Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, Jan 28, 2015
This systematic literature review evaluated the clinical efficacy and safety of interventions use... more This systematic literature review evaluated the clinical efficacy and safety of interventions used in relapsed/refractory follicular lymphoma. Primary efficacy outcomes were objective response rate, progression-free survival and overall survival. Safety endpoints were grade 3/4 toxicities, serious adverse events and withdrawals or deaths due to toxicity. Studies were selected if they were randomized controlled trials reporting on the efficacy or safety of treatments for relapsed or refractory follicular lymphoma, and if outcomes were reported separately from trials that included other lymphoid neoplasms. We used the Bucher method for conducting adjusted indirect comparisons within a meta-analysis. We identified 10 randomized controlled trials of treatments for relapsed/refractory follicular lymphoma. The most prominent drug investigated (alone or in combination) was rituximab. Most trials did not report median overall survival. Two trials reported median event-free survival (range, ...
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2005
The somatic, neurocognitive, and psychiatric side effects of biological response modifiers (BRMs)... more The somatic, neurocognitive, and psychiatric side effects of biological response modifiers (BRMs) have been documented in specific patient samples. Although these side effects likely have a predictable impact on patients quality of life (QOL), no instrument currently measures the cumulative effect of the various complaints patients' report. The current study investigated the reliability and validity of the Functional Assessment of Cancer Treatment-Biological Response Modifier (FACT-BRM) scale for measuring QOL in a sample of melanoma patients receiving interferon. Measures of distress, depression, and fatigue were also obtained using standardized, well-validated instruments. Results indicate increased symptom burden, depression, and fatigue, and decreased quality of life over 4 months of IFN therapy. The FACT-BRM demonstrated good psychometrics and sensitivity to change, and thus appears to be a good instrument for measuring QOL in patients receiving BRMs.
Respo nse styles theory (Nolen-Hoeksem a, 1987) provid ed the im petus for recent research effort... more Respo nse styles theory (Nolen-Hoeksem a, 1987) provid ed the im petus for recent research efforts in vestigatin g the effects of rum in atio n an d distractio n on depressed m ood. This study elab orates on previo us research by exam in in g th e sequential effects of engagin g in rum in atin g an d distractin g tasks. Resu lts from tw o stu dies in dicated that in itially engagin g in a rum in atin g task m ain tain ed postin duction levels of dysphoric m ood, w hereas in itially engagin g in a d istractin g task reduced levels o f dysphoric m ood. More im portan t, ho wever, w ere the effects of task order on m ood. When particip an ts engaged in a distractin g task follo w in g a rum in atin g task, dysp horic m ood, w hich had been m ain tain ed w ith a rum in atin g task, w as red uced to premo odin duction levels. O f equal im portan ce, in divid uals w ho rum in ated after distractin g m ain tain ed their cu rrent m o od an d did not report an in crease in depressed m oo d. In the second stud y, engagin g in sequential rum in atio n tasks further prolo nged depressed m ood, w hereas engagin g in sequential distractio n tasks reduced depressed m ood. The results suggest that, alth ough engagin g in a rum in atio n task m ain tain s depressed m ood an d engagin g in a distractio n task redu ces it, th e order in w hich these tasks are perform ed is also im portan t. The im plicatio ns of these results for resp onse styles theory are d iscussed.
This systematic literature review was designed to assess information on the clinical efficacy and... more This systematic literature review was designed to assess information on the clinical efficacy and safety of interventions used in the treatment of refractory or relapsed diffuse large B-cell lymphoma (R/R DLBCL) and to perform a metaanalysis if possible. We searched databases (PubMed, EMBASE, and Cochrane Library for articles from 1997 to August 2, 2012 reported in English), conference abstracts, bibliographic reference lists, and the ClinicalTrials.gov database for phase II to IV studies with results. Studies had to report on patients with R/R DLBCL who were not eligible to receive high-dose therapy (HDT) with stem cell transplantation (SCT) (autologous or allogeneic). Mixed-type non-Hodgkin lymphoma (NHL) studies were required to report R/R DLBCL outcomes separately. We identified 55 studies that presented outcomes data separately for patients with R/R DLBCL. Of 7 comparative studies, only 4 were randomized controlled trials (RCTs). In the 2 RCTs with a common regimen, the patient populations differed too greatly to perform a valid meta-analysis. The 48 single-arm studies identified were typically small (n < 50 in most), with 31% reporting median progression-free survival (PFS) or overall survival (OS) specifically for the R/R DLBCL population. In these studies, median OS ranged from 4 to 13 months. The small number of RCTs in R/R DLBCL precludes identifying optimal treatments. Small sample size, infrequent reporting of OS and PFS separated by histologic type, and limited information on patient characteristics also hinder comparison of results. Randomized studies are needed to demonstrate which current therapies have advantages for improving survival and other important clinical outcomes in patients with R/R DLBCL.
This systematic literature review was designed to assess information on the clinical efficacy and... more This systematic literature review was designed to assess information on the clinical efficacy and safety of interventions used in the treatment of refractory or relapsed diffuse large B-cell lymphoma (R/R DLBCL) and to perform a metaanalysis if possible. We searched databases (PubMed, EMBASE, and Cochrane Library for articles from 1997 to August 2, 2012 reported in English), conference abstracts, bibliographic reference lists, and the ClinicalTrials.gov database for phase II to IV studies with results. Studies had to report on patients with R/R DLBCL who were not eligible to receive high-dose therapy (HDT) with stem cell transplantation (SCT) (autologous or allogeneic). Mixed-type non-Hodgkin lymphoma (NHL) studies were required to report R/R DLBCL outcomes separately. We identified 55 studies that presented outcomes data separately for patients with R/R DLBCL. Of 7 comparative studies, only 4 were randomized controlled trials (RCTs). In the 2 RCTs with a common regimen, the patient populations differed too greatly to perform a valid meta-analysis. The 48 single-arm studies identified were typically small (n < 50 in most), with 31% reporting median progression-free survival (PFS) or overall survival (OS) specifically for the R/R DLBCL population. In these studies, median OS ranged from 4 to 13 months. The small number of RCTs in R/R DLBCL precludes identifying optimal treatments. Small sample size, infrequent reporting of OS and PFS separated by histologic type, and limited information on patient characteristics also hinder comparison of results. Randomized studies are needed to demonstrate which current therapies have advantages for improving survival and other important clinical outcomes in patients with R/R DLBCL.
This systematic literature review with meta-analysis was conducted on the clinical efficacy and s... more This systematic literature review with meta-analysis was conducted on the clinical efficacy and safety of interventions used in the treatment of chronic lymphocytic leukemia (CLL). We systematically searched databases (PubMed, Cochrane Library, and Embase; 1997 to August 2, 2012), conference abstracts, bibliographic reference lists, recent reviews, and Clinicaltrials.gov. Primary efficacy outcomes were objective response rate, progression-free survival, and overall survival. Safety end points were Grade 3/4 toxicities, serious adverse events, withdrawals because of toxicity, and deaths due to toxicity. Studies were selected if they were randomized controlled trials (RCTs) reporting on the efficacy or safety of relapsed or refractory CLL and if outcomes for CLL were reported separately from trials that included other lymphoid neoplasms. We used the Bucher method for conducting adjusted indirect comparisons within a meta-analysis. We identified 6 RCTs of pharmacologic treatment for relapsed/refractory CLL. The most common drugs investigated (alone or in combination) were fludarabine and cyclophosphamide. When reported, median overall survival ranged from 27.3 to 52.9 months, and overall response rate from 58% to 82%. Although meta-analysis of efficacy results was considered, details are not presented because only 3 studies qualified and the common comparator treatment was not clinically relevant. The relatively small number of RCTs, few overlapping treatment arms, and variability in end points studied make it difficult to formally compare therapies for relapsed/refractory CLL. Significant variability in RCT features presents a further challenge to meaningful comparisons. Additional well-designed RCTs are needed to fully understand the relative efficacy and safety of older and more recently developed therapies.
Journal of Clinical Psychology in Medical Settings - J CLIN PSYCHOL MED SETTINGS, 2002
This study presents a retrospective assessment of a psychological intervention examined for its p... more This study presents a retrospective assessment of a psychological intervention examined for its potential cost-effectiveness if implemented into standard care. It discusses (1) the cost of instituting a psychological intervention for distressed melanoma patients, (2) the effectiveness of that intervention for reducing distress when compared with a standard care group, and (3) the costs of providing the treatment as compared to costs of physician time to answer distress-driven questions as part of standard care. Although the per-minute cost of providing the psychological intervention was marginally greater than standard care, providing the intervention was significantly cheaper in terms of distress reduction. Inclusion of 60% payer reimbursement rates for the intervention further suggested that incorporating a psychological intervention into standard medical care for melanoma patients would potentially generate revenue.
OBJECTIVES: Through advances in molecular biology, new treatment options for patients with metast... more OBJECTIVES: Through advances in molecular biology, new treatment options for patients with metastatic renal cell carcinoma (RCC) have become available. Although the efficacy of these new treatments has been demonstrated in large randomised controlled trials, their effectiveness in daily practice is currently unknown. The aim of this study was to evaluate the use of new treatment options for patients with metastatic RCC in Dutch daily practice. METHODS: A populationbased registry has been created to collect data about patients diagnosed with metastatic RCC in 2008, 2009 and 2010. This registry contains data on patient and tumour characteristics, treatment details (e.g., dosing) and response to treatment. All patients living within the regions of four Dutch Cancer Registries are being included in this study. Together these registries cover 55% of The Netherlands. RESULTS: Forty-three patients, all diagnosed with metastatic RCC in 2008, are currently included in our registry. Of these, 47% received systemic therapy (mostly sunitinib), while all others received surgery or palliative care. Patients treated with sunitinib in Dutch daily practice were five years older and had a worse ECOG performance status than patients treated with sunitinib in the pivotal phase 3 trial. While the mean daily dose seen in Dutch daily practice in the first cycle was comparable to the recommended dose (50 mg), the mean daily dose in the second cycle was lower, i.e. 44 mg. CONCLUSIONS: The number of Dutch patients with metastatic RCC treated with systemic therapy will increase because of new treatments available since 2008. This study suggests that patients treated with systemic therapy in daily practice have a different profile and receive different dose schedules than patients treated in the pivotal trial. Consequently, the effectiveness of the new treatment options in Dutch daily practice may also differ from what was seen in the trial.
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire ... more The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) is a widely used quality-of-life measure in oncology. The ability to translate QLQ-C30 responses into utility scores would further expand its use in medical decision-making. The aims of this study were to: 1) map QLQ-C30 responses onto patient time trade-off utility scores; and 2) compare a multiattribute approach to a global evaluation approach to modeling utility scores. Methods: Two distinct approaches were applied to data from 1432 cancer patients. The multiattribute approach used psychometric analysis and expert input to select a subset of functioning and symptom scale items for modeling. The second approach focused on global health and quality-oflife items based on a conceptual model. Model selection criteria included parsimony, statistical significance and logical consistency of parameter estimates, predictive accuracy, number of states described, and scale range.
Low lipid levels have been found in some studies to be associated with non-illness deaths (i.e. s... more Low lipid levels have been found in some studies to be associated with non-illness deaths (i.e. suicides, homicides and accidents). Likewise, low lipids have been associated with measures of emotional distress (e.g. anxiety, depression, hostility) in medical, psychiatric and forensic populations whose age, health status and/or personal habits make interpretation of the association problematic. The present study examined the relationship of lipid levels to emotional distress in young, healthy, male college students. To investigate possible confounding/mediating relationships, a number of clinical risk factors and demographic variables were also studied (age, drug use, alcohol use, nicotine use, exercise, obesity and resting hemodynamic values). Bivariate correlations showed that measures of emotional distress (SCL-90-R subscales, Toronto Alexithymia Scale) and clinical/demographic factors (alcohol use, age, blood pressure, weight and heart rate) were associated with lipid levels. In a hierarchical set multiple regression, only alcohol use, age, resting systolic blood pressure and the positive symptom total from the SCL-90-R were unique correlates of total cholesterol. These results add additional support to the growing evidence of an association between lipid levels and emotional functioning. Importantly, this relationship appears to exist apart from other risk factors. While various studies have focused on speci®c dimensions of emotional distress (i.e. anxiety, depression, hostility), the results of the present study suggest that more global measures of emotional distress might better account for the association with lipid levels.
This study examined the impact of personal and family cancer history on psychological distress. R... more This study examined the impact of personal and family cancer history on psychological distress. Regression analyses were conducted on a nationally representative sample of adult individuals who participated in the 2000 National Health Interview Survey, USA. Effects on distress of a personal cancer history, any family cancer history, or mother, father, sister or brother with a cancer history were examined. The interaction of personal and family cancer histories and three-way interactions with gender were also assessed. Analyses indicate that having either a personal or family cancer history is linked with significantly greater psychological distress and there is evidence of an interaction. Three-way interactions with gender were not found. Consistent with prior research, results demonstrated that cancer survivors are more distressed than the general population. Results extend prior research by indicating that having a first-degree relative with cancer increases risk for distress, and having personal and family cancer histories may exert a synergistic effect on distress.
The somatic, neurocognitive, and psychiatric side effects of biological response modifiers (BRMs)... more The somatic, neurocognitive, and psychiatric side effects of biological response modifiers (BRMs) have been documented in specific patient samples. Although these side effects likely have a predictable impact on patients quality of life (QOL), no instrument currently measures the cumulative effect of the various complaints patients' report. The current study investigated the reliability and validity of the Functional Assessment of Cancer Treatment-Biological Response Modifier (FACT-BRM) scale for measuring QOL in a sample of melanoma patients receiving interferon. Measures of distress, depression, and fatigue were also obtained using standardized, well-validated instruments. Results indicate increased symptom burden, depression, and fatigue, and decreased quality of life over 4 months of IFN therapy. The FACT-BRM demonstrated good psychometrics and sensitivity to change, and thus appears to be a good instrument for measuring QOL in patients receiving BRMs.
Intrusive thoughts about cancer, often identified as 'cancer-specific worries' or 'cancer-specifi... more Intrusive thoughts about cancer, often identified as 'cancer-specific worries' or 'cancer-specific distress', have been postulated to be associated with dysfunction in women at increased risk of developing breast or ovarian cancer. The current study discusses the development and validation of a measure designed to assess women's perceptions of the interference such worries create in their daily functioning. Analyses revealed that approximately two-thirds of a high-risk breast cancer clinic sample perceived worries about breast cancer as interfering with their functioning across a variety of life domains. Multiple regression analyses indicated that worry interference scores predicted Profile of Mood States (POMS) Anxiety and Confusion, and Short Form-36 (SF-36) Role-Emotional and Mental Health scores after the effects of other variables such as frequency of worry about breast cancer, and having a family history of cancer had been considered. Women who perceived their worries as interfering with their functioning reported higher levels of anxiety and confusion, and diminished mental health and role functioning. The results add to the expanding area of anxiety/distress in at-risk populations by providing (1) a direct measure of the perceived interference associated with breast cancer-specific thoughts, (2) a validation of the measure via its associations with standard measures of emotional distress and health functioning, and (3) evidence of the measure's incremental predictive value in explaining distress and quality of life, after consideration of background variables, such as having a family history of cancer.
Treatment of malignant melanoma with interferon-alpha has been associated with a variety of side ... more Treatment of malignant melanoma with interferon-alpha has been associated with a variety of side effects ranging from fatigue to depression, and a concomitant impact on quality of life (QOL), in a variety of case reports and cross-sectional clinical trials. Few, if any, studies have been conducted with the express purpose of assessing the longitudinal course of depression, fatigue, and QOL before and during interferon therapy. The current study reports on 16 patients who were assessed at 6 points in time: baseline, post high dose, and 1, 2, 3, and 6 months post high dose treatment with interferon-alpha with the Brief Symptom Inventory, Beck Depression Inventory, Revised Piper Fatigue Scale, and Functional Assessment of Cancer Therapy-Biological Response Modifiers. Results revealed consistent changes from baseline through 6 month assessment. Specifically, increased somatic complaints, depression, and fatigue were observed on the BSI, BDI, and RPFS, respectively. Additional reductions in QOL on the FACT-BRM were also identified. The findings suggest that IFN has a significant effect on QOL, but that it may be the somatic symptoms of fatigue that contribute to changes on measures of mood. Limiting the amount of fatigue and depression would appear to be significant if individuals are to successfully complete IFN therapy.
Objective: Although evidence mounts regarding the beneficial effects of physical activity (PA) in... more Objective: Although evidence mounts regarding the beneficial effects of physical activity (PA) interventions for breast cancer survivors, not all interventions have produced significant improvement in mood. Relaxation training may be a promising strategy for enhancing mood effects from these interventions. The goals of Be Calm and Move On were to assess the feasibility, acceptability and preliminary effects of a 12-week combined PA and relaxation intervention for breast cancer survivors.
Background: Pancreatic cancer is the fourth leading cause of cancer-related death in the United S... more Background: Pancreatic cancer is the fourth leading cause of cancer-related death in the United States, unsuccessful in significantly improving 5-year survival. A diagnosis of pancreatic cancer may be associated with increased psychological distress, yet remarkably little is known about the degree of psychological distress experienced by these patients at the time of diagnosis and treatment.
Testicular cancer is the most common cancer in white males between the ages of 15 and 45 years. T... more Testicular cancer is the most common cancer in white males between the ages of 15 and 45 years. Treatment may include the administration of chemotherapy which has been associated with changes in emotional distress, quality of life, and symptom distress in other cancers. The current study was designed to evaluate the course of these constructs in a sample of testicular cancer patients undergoing chemotherapy. Patients completed measures of emotional distress and quality of life prior to, during, and after chemotherapy, with symptom distress measured during chemotherapy. Thirty percent of patients reported moderate to high levels of distress at pre-treatment baseline that was associated with worse quality of life. Initial anxiety and distress decreased and stayed low through chemotherapy and post-treatment follow-up. There were no significant changes in fatigue, nausea or change in appearance during chemotherapy. The results suggest that some patients evidence pre-treatment anxiety and distress that appears to be primarily anticipatory, decreases over the course of chemotherapy, and occurs in the context of improved quality of life and reduced symptom severity. Deleterious changes in emotional distress, quality of life, and symptom distress seen in other cancer populations were not apparent in our sample of testicular cancer patients.
Professional Psychology: Research and Practice, 2004
Efficacy research is insufficient and ineffective in changing practice, despite a large supportin... more Efficacy research is insufficient and ineffective in changing practice, despite a large supporting psychotherapy efficacy literature. Concurrently, demand for supporting data and the burden on everyday practice for generating these data is increasing. The disconnect between efficacy and effectiveness is due to a lack of conceptual and methodological tools for testing efficacious procedures in real-world settings, particularly medical contexts. This
Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, Jan 28, 2015
This systematic literature review evaluated the clinical efficacy and safety of interventions use... more This systematic literature review evaluated the clinical efficacy and safety of interventions used in relapsed/refractory follicular lymphoma. Primary efficacy outcomes were objective response rate, progression-free survival and overall survival. Safety endpoints were grade 3/4 toxicities, serious adverse events and withdrawals or deaths due to toxicity. Studies were selected if they were randomized controlled trials reporting on the efficacy or safety of treatments for relapsed or refractory follicular lymphoma, and if outcomes were reported separately from trials that included other lymphoid neoplasms. We used the Bucher method for conducting adjusted indirect comparisons within a meta-analysis. We identified 10 randomized controlled trials of treatments for relapsed/refractory follicular lymphoma. The most prominent drug investigated (alone or in combination) was rituximab. Most trials did not report median overall survival. Two trials reported median event-free survival (range, ...
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2005
The somatic, neurocognitive, and psychiatric side effects of biological response modifiers (BRMs)... more The somatic, neurocognitive, and psychiatric side effects of biological response modifiers (BRMs) have been documented in specific patient samples. Although these side effects likely have a predictable impact on patients quality of life (QOL), no instrument currently measures the cumulative effect of the various complaints patients' report. The current study investigated the reliability and validity of the Functional Assessment of Cancer Treatment-Biological Response Modifier (FACT-BRM) scale for measuring QOL in a sample of melanoma patients receiving interferon. Measures of distress, depression, and fatigue were also obtained using standardized, well-validated instruments. Results indicate increased symptom burden, depression, and fatigue, and decreased quality of life over 4 months of IFN therapy. The FACT-BRM demonstrated good psychometrics and sensitivity to change, and thus appears to be a good instrument for measuring QOL in patients receiving BRMs.
Respo nse styles theory (Nolen-Hoeksem a, 1987) provid ed the im petus for recent research effort... more Respo nse styles theory (Nolen-Hoeksem a, 1987) provid ed the im petus for recent research efforts in vestigatin g the effects of rum in atio n an d distractio n on depressed m ood. This study elab orates on previo us research by exam in in g th e sequential effects of engagin g in rum in atin g an d distractin g tasks. Resu lts from tw o stu dies in dicated that in itially engagin g in a rum in atin g task m ain tain ed postin duction levels of dysphoric m ood, w hereas in itially engagin g in a d istractin g task reduced levels o f dysphoric m ood. More im portan t, ho wever, w ere the effects of task order on m ood. When particip an ts engaged in a distractin g task follo w in g a rum in atin g task, dysp horic m ood, w hich had been m ain tain ed w ith a rum in atin g task, w as red uced to premo odin duction levels. O f equal im portan ce, in divid uals w ho rum in ated after distractin g m ain tain ed their cu rrent m o od an d did not report an in crease in depressed m oo d. In the second stud y, engagin g in sequential rum in atio n tasks further prolo nged depressed m ood, w hereas engagin g in sequential distractio n tasks reduced depressed m ood. The results suggest that, alth ough engagin g in a rum in atio n task m ain tain s depressed m ood an d engagin g in a distractio n task redu ces it, th e order in w hich these tasks are perform ed is also im portan t. The im plicatio ns of these results for resp onse styles theory are d iscussed.
This systematic literature review was designed to assess information on the clinical efficacy and... more This systematic literature review was designed to assess information on the clinical efficacy and safety of interventions used in the treatment of refractory or relapsed diffuse large B-cell lymphoma (R/R DLBCL) and to perform a metaanalysis if possible. We searched databases (PubMed, EMBASE, and Cochrane Library for articles from 1997 to August 2, 2012 reported in English), conference abstracts, bibliographic reference lists, and the ClinicalTrials.gov database for phase II to IV studies with results. Studies had to report on patients with R/R DLBCL who were not eligible to receive high-dose therapy (HDT) with stem cell transplantation (SCT) (autologous or allogeneic). Mixed-type non-Hodgkin lymphoma (NHL) studies were required to report R/R DLBCL outcomes separately. We identified 55 studies that presented outcomes data separately for patients with R/R DLBCL. Of 7 comparative studies, only 4 were randomized controlled trials (RCTs). In the 2 RCTs with a common regimen, the patient populations differed too greatly to perform a valid meta-analysis. The 48 single-arm studies identified were typically small (n < 50 in most), with 31% reporting median progression-free survival (PFS) or overall survival (OS) specifically for the R/R DLBCL population. In these studies, median OS ranged from 4 to 13 months. The small number of RCTs in R/R DLBCL precludes identifying optimal treatments. Small sample size, infrequent reporting of OS and PFS separated by histologic type, and limited information on patient characteristics also hinder comparison of results. Randomized studies are needed to demonstrate which current therapies have advantages for improving survival and other important clinical outcomes in patients with R/R DLBCL.
This systematic literature review was designed to assess information on the clinical efficacy and... more This systematic literature review was designed to assess information on the clinical efficacy and safety of interventions used in the treatment of refractory or relapsed diffuse large B-cell lymphoma (R/R DLBCL) and to perform a metaanalysis if possible. We searched databases (PubMed, EMBASE, and Cochrane Library for articles from 1997 to August 2, 2012 reported in English), conference abstracts, bibliographic reference lists, and the ClinicalTrials.gov database for phase II to IV studies with results. Studies had to report on patients with R/R DLBCL who were not eligible to receive high-dose therapy (HDT) with stem cell transplantation (SCT) (autologous or allogeneic). Mixed-type non-Hodgkin lymphoma (NHL) studies were required to report R/R DLBCL outcomes separately. We identified 55 studies that presented outcomes data separately for patients with R/R DLBCL. Of 7 comparative studies, only 4 were randomized controlled trials (RCTs). In the 2 RCTs with a common regimen, the patient populations differed too greatly to perform a valid meta-analysis. The 48 single-arm studies identified were typically small (n < 50 in most), with 31% reporting median progression-free survival (PFS) or overall survival (OS) specifically for the R/R DLBCL population. In these studies, median OS ranged from 4 to 13 months. The small number of RCTs in R/R DLBCL precludes identifying optimal treatments. Small sample size, infrequent reporting of OS and PFS separated by histologic type, and limited information on patient characteristics also hinder comparison of results. Randomized studies are needed to demonstrate which current therapies have advantages for improving survival and other important clinical outcomes in patients with R/R DLBCL.
This systematic literature review with meta-analysis was conducted on the clinical efficacy and s... more This systematic literature review with meta-analysis was conducted on the clinical efficacy and safety of interventions used in the treatment of chronic lymphocytic leukemia (CLL). We systematically searched databases (PubMed, Cochrane Library, and Embase; 1997 to August 2, 2012), conference abstracts, bibliographic reference lists, recent reviews, and Clinicaltrials.gov. Primary efficacy outcomes were objective response rate, progression-free survival, and overall survival. Safety end points were Grade 3/4 toxicities, serious adverse events, withdrawals because of toxicity, and deaths due to toxicity. Studies were selected if they were randomized controlled trials (RCTs) reporting on the efficacy or safety of relapsed or refractory CLL and if outcomes for CLL were reported separately from trials that included other lymphoid neoplasms. We used the Bucher method for conducting adjusted indirect comparisons within a meta-analysis. We identified 6 RCTs of pharmacologic treatment for relapsed/refractory CLL. The most common drugs investigated (alone or in combination) were fludarabine and cyclophosphamide. When reported, median overall survival ranged from 27.3 to 52.9 months, and overall response rate from 58% to 82%. Although meta-analysis of efficacy results was considered, details are not presented because only 3 studies qualified and the common comparator treatment was not clinically relevant. The relatively small number of RCTs, few overlapping treatment arms, and variability in end points studied make it difficult to formally compare therapies for relapsed/refractory CLL. Significant variability in RCT features presents a further challenge to meaningful comparisons. Additional well-designed RCTs are needed to fully understand the relative efficacy and safety of older and more recently developed therapies.
Journal of Clinical Psychology in Medical Settings - J CLIN PSYCHOL MED SETTINGS, 2002
This study presents a retrospective assessment of a psychological intervention examined for its p... more This study presents a retrospective assessment of a psychological intervention examined for its potential cost-effectiveness if implemented into standard care. It discusses (1) the cost of instituting a psychological intervention for distressed melanoma patients, (2) the effectiveness of that intervention for reducing distress when compared with a standard care group, and (3) the costs of providing the treatment as compared to costs of physician time to answer distress-driven questions as part of standard care. Although the per-minute cost of providing the psychological intervention was marginally greater than standard care, providing the intervention was significantly cheaper in terms of distress reduction. Inclusion of 60% payer reimbursement rates for the intervention further suggested that incorporating a psychological intervention into standard medical care for melanoma patients would potentially generate revenue.
OBJECTIVES: Through advances in molecular biology, new treatment options for patients with metast... more OBJECTIVES: Through advances in molecular biology, new treatment options for patients with metastatic renal cell carcinoma (RCC) have become available. Although the efficacy of these new treatments has been demonstrated in large randomised controlled trials, their effectiveness in daily practice is currently unknown. The aim of this study was to evaluate the use of new treatment options for patients with metastatic RCC in Dutch daily practice. METHODS: A populationbased registry has been created to collect data about patients diagnosed with metastatic RCC in 2008, 2009 and 2010. This registry contains data on patient and tumour characteristics, treatment details (e.g., dosing) and response to treatment. All patients living within the regions of four Dutch Cancer Registries are being included in this study. Together these registries cover 55% of The Netherlands. RESULTS: Forty-three patients, all diagnosed with metastatic RCC in 2008, are currently included in our registry. Of these, 47% received systemic therapy (mostly sunitinib), while all others received surgery or palliative care. Patients treated with sunitinib in Dutch daily practice were five years older and had a worse ECOG performance status than patients treated with sunitinib in the pivotal phase 3 trial. While the mean daily dose seen in Dutch daily practice in the first cycle was comparable to the recommended dose (50 mg), the mean daily dose in the second cycle was lower, i.e. 44 mg. CONCLUSIONS: The number of Dutch patients with metastatic RCC treated with systemic therapy will increase because of new treatments available since 2008. This study suggests that patients treated with systemic therapy in daily practice have a different profile and receive different dose schedules than patients treated in the pivotal trial. Consequently, the effectiveness of the new treatment options in Dutch daily practice may also differ from what was seen in the trial.
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire ... more The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) is a widely used quality-of-life measure in oncology. The ability to translate QLQ-C30 responses into utility scores would further expand its use in medical decision-making. The aims of this study were to: 1) map QLQ-C30 responses onto patient time trade-off utility scores; and 2) compare a multiattribute approach to a global evaluation approach to modeling utility scores. Methods: Two distinct approaches were applied to data from 1432 cancer patients. The multiattribute approach used psychometric analysis and expert input to select a subset of functioning and symptom scale items for modeling. The second approach focused on global health and quality-oflife items based on a conceptual model. Model selection criteria included parsimony, statistical significance and logical consistency of parameter estimates, predictive accuracy, number of states described, and scale range.
Low lipid levels have been found in some studies to be associated with non-illness deaths (i.e. s... more Low lipid levels have been found in some studies to be associated with non-illness deaths (i.e. suicides, homicides and accidents). Likewise, low lipids have been associated with measures of emotional distress (e.g. anxiety, depression, hostility) in medical, psychiatric and forensic populations whose age, health status and/or personal habits make interpretation of the association problematic. The present study examined the relationship of lipid levels to emotional distress in young, healthy, male college students. To investigate possible confounding/mediating relationships, a number of clinical risk factors and demographic variables were also studied (age, drug use, alcohol use, nicotine use, exercise, obesity and resting hemodynamic values). Bivariate correlations showed that measures of emotional distress (SCL-90-R subscales, Toronto Alexithymia Scale) and clinical/demographic factors (alcohol use, age, blood pressure, weight and heart rate) were associated with lipid levels. In a hierarchical set multiple regression, only alcohol use, age, resting systolic blood pressure and the positive symptom total from the SCL-90-R were unique correlates of total cholesterol. These results add additional support to the growing evidence of an association between lipid levels and emotional functioning. Importantly, this relationship appears to exist apart from other risk factors. While various studies have focused on speci®c dimensions of emotional distress (i.e. anxiety, depression, hostility), the results of the present study suggest that more global measures of emotional distress might better account for the association with lipid levels.
This study examined the impact of personal and family cancer history on psychological distress. R... more This study examined the impact of personal and family cancer history on psychological distress. Regression analyses were conducted on a nationally representative sample of adult individuals who participated in the 2000 National Health Interview Survey, USA. Effects on distress of a personal cancer history, any family cancer history, or mother, father, sister or brother with a cancer history were examined. The interaction of personal and family cancer histories and three-way interactions with gender were also assessed. Analyses indicate that having either a personal or family cancer history is linked with significantly greater psychological distress and there is evidence of an interaction. Three-way interactions with gender were not found. Consistent with prior research, results demonstrated that cancer survivors are more distressed than the general population. Results extend prior research by indicating that having a first-degree relative with cancer increases risk for distress, and having personal and family cancer histories may exert a synergistic effect on distress.
The somatic, neurocognitive, and psychiatric side effects of biological response modifiers (BRMs)... more The somatic, neurocognitive, and psychiatric side effects of biological response modifiers (BRMs) have been documented in specific patient samples. Although these side effects likely have a predictable impact on patients quality of life (QOL), no instrument currently measures the cumulative effect of the various complaints patients' report. The current study investigated the reliability and validity of the Functional Assessment of Cancer Treatment-Biological Response Modifier (FACT-BRM) scale for measuring QOL in a sample of melanoma patients receiving interferon. Measures of distress, depression, and fatigue were also obtained using standardized, well-validated instruments. Results indicate increased symptom burden, depression, and fatigue, and decreased quality of life over 4 months of IFN therapy. The FACT-BRM demonstrated good psychometrics and sensitivity to change, and thus appears to be a good instrument for measuring QOL in patients receiving BRMs.
Intrusive thoughts about cancer, often identified as 'cancer-specific worries' or 'cancer-specifi... more Intrusive thoughts about cancer, often identified as 'cancer-specific worries' or 'cancer-specific distress', have been postulated to be associated with dysfunction in women at increased risk of developing breast or ovarian cancer. The current study discusses the development and validation of a measure designed to assess women's perceptions of the interference such worries create in their daily functioning. Analyses revealed that approximately two-thirds of a high-risk breast cancer clinic sample perceived worries about breast cancer as interfering with their functioning across a variety of life domains. Multiple regression analyses indicated that worry interference scores predicted Profile of Mood States (POMS) Anxiety and Confusion, and Short Form-36 (SF-36) Role-Emotional and Mental Health scores after the effects of other variables such as frequency of worry about breast cancer, and having a family history of cancer had been considered. Women who perceived their worries as interfering with their functioning reported higher levels of anxiety and confusion, and diminished mental health and role functioning. The results add to the expanding area of anxiety/distress in at-risk populations by providing (1) a direct measure of the perceived interference associated with breast cancer-specific thoughts, (2) a validation of the measure via its associations with standard measures of emotional distress and health functioning, and (3) evidence of the measure's incremental predictive value in explaining distress and quality of life, after consideration of background variables, such as having a family history of cancer.
Treatment of malignant melanoma with interferon-alpha has been associated with a variety of side ... more Treatment of malignant melanoma with interferon-alpha has been associated with a variety of side effects ranging from fatigue to depression, and a concomitant impact on quality of life (QOL), in a variety of case reports and cross-sectional clinical trials. Few, if any, studies have been conducted with the express purpose of assessing the longitudinal course of depression, fatigue, and QOL before and during interferon therapy. The current study reports on 16 patients who were assessed at 6 points in time: baseline, post high dose, and 1, 2, 3, and 6 months post high dose treatment with interferon-alpha with the Brief Symptom Inventory, Beck Depression Inventory, Revised Piper Fatigue Scale, and Functional Assessment of Cancer Therapy-Biological Response Modifiers. Results revealed consistent changes from baseline through 6 month assessment. Specifically, increased somatic complaints, depression, and fatigue were observed on the BSI, BDI, and RPFS, respectively. Additional reductions in QOL on the FACT-BRM were also identified. The findings suggest that IFN has a significant effect on QOL, but that it may be the somatic symptoms of fatigue that contribute to changes on measures of mood. Limiting the amount of fatigue and depression would appear to be significant if individuals are to successfully complete IFN therapy.
Objective: Although evidence mounts regarding the beneficial effects of physical activity (PA) in... more Objective: Although evidence mounts regarding the beneficial effects of physical activity (PA) interventions for breast cancer survivors, not all interventions have produced significant improvement in mood. Relaxation training may be a promising strategy for enhancing mood effects from these interventions. The goals of Be Calm and Move On were to assess the feasibility, acceptability and preliminary effects of a 12-week combined PA and relaxation intervention for breast cancer survivors.
Background: Pancreatic cancer is the fourth leading cause of cancer-related death in the United S... more Background: Pancreatic cancer is the fourth leading cause of cancer-related death in the United States, unsuccessful in significantly improving 5-year survival. A diagnosis of pancreatic cancer may be associated with increased psychological distress, yet remarkably little is known about the degree of psychological distress experienced by these patients at the time of diagnosis and treatment.
Testicular cancer is the most common cancer in white males between the ages of 15 and 45 years. T... more Testicular cancer is the most common cancer in white males between the ages of 15 and 45 years. Treatment may include the administration of chemotherapy which has been associated with changes in emotional distress, quality of life, and symptom distress in other cancers. The current study was designed to evaluate the course of these constructs in a sample of testicular cancer patients undergoing chemotherapy. Patients completed measures of emotional distress and quality of life prior to, during, and after chemotherapy, with symptom distress measured during chemotherapy. Thirty percent of patients reported moderate to high levels of distress at pre-treatment baseline that was associated with worse quality of life. Initial anxiety and distress decreased and stayed low through chemotherapy and post-treatment follow-up. There were no significant changes in fatigue, nausea or change in appearance during chemotherapy. The results suggest that some patients evidence pre-treatment anxiety and distress that appears to be primarily anticipatory, decreases over the course of chemotherapy, and occurs in the context of improved quality of life and reduced symptom severity. Deleterious changes in emotional distress, quality of life, and symptom distress seen in other cancer populations were not apparent in our sample of testicular cancer patients.
Professional Psychology: Research and Practice, 2004
Efficacy research is insufficient and ineffective in changing practice, despite a large supportin... more Efficacy research is insufficient and ineffective in changing practice, despite a large supporting psychotherapy efficacy literature. Concurrently, demand for supporting data and the burden on everyday practice for generating these data is increasing. The disconnect between efficacy and effectiveness is due to a lack of conceptual and methodological tools for testing efficacious procedures in real-world settings, particularly medical contexts. This
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