Cognitive effects of long-term androgen deprivation therapy in older men with prostate cancer.

OBJECTIVE: Androgen deprivation therapy (ADT) is a common treatment for prostate cancer (PCa), with increasing numbers of men on ADT for longer. Limited evidence suggests ADT impacts cognition. This study addressed gaps in the literature by focusing on older men with PCa and assessing ADT usage longer than 1 year. METHODS: This study of 133 men ≥65 years of age with PCa included two groups: (1) men on ADT for 1-3 years (ADT-exposed), and (2) a comparison group of men with PCa not on ADT (ADT-unexposed). Group comparisons on individual neuropsychological test scores are reported, as well as effect sizes (Cohen's d). RESULTS: Half (n = 67) of the sample was ADT-exposed and half (n = 66) were unexposed. The average age was 72 years, most were White, and over 50% had at least secondary education. There were no statistically significant differences between groups by age, race, or education. Unadjusted analyses showed the ADT-exposed group, compared with the ADT-unexposed group, performed significantly lower in domains of verbal learning (d = 0.45-0.52, p = 0.01 to <0.01), verbal recall (d = 0.33-0.54, p = 0.06 to <0.01), and possible effects in visuospatial construction (d = 0.33, p = 0.08 to 0.06). When controlling for age and education, similar patterns emerged. The ADT exposed-group performed significantly lower in domains of verbal learning (d = 0.45-0.52, p = 0.06 to 0.03) and verbal recall (d = 0.33-0.54, p = 0.11 to 0.03), and possible effects in visuospatial construction d = 0.33, p = 0.18 to 0.13. CONCLUSIONS: This study suggests long-term ADT exposure impacts verbal learning, verbal recall, and possibly visuospatial abilities in older men (≥65) with PCa. The potential cognitive effects of ADT should be discussed with older patients considering long-term use of ADT.

A survey of statistical methods utilized for analysis of randomized controlled trials of behavioral interventions.

OBJECTIVES: Given the many statistical analysis options used for randomized controlled trials (RCTs) of behavioral interventions and the lack of clear guidance for analysis selection, the present study aimed to characterize the predominate statistical analyses utilized in RCTs in palliative care and behavioral research and to highlight the relative strengths and weaknesses of each of these methods as guidance for future researchers and reform. METHODS: All RCTs published between 2015 and 2021 were systematically extracted from 4 behavioral medicine journals and analyzed based on prespecified inclusion criteria. Two independent raters classified each of the manuscripts into 1 of 5 RCT analysis strategies. RESULTS: There was wide variation in the methods used. The 2 most prevalent analyses for RCTs were longitudinal modeling and analysis of covariance. Application of method varied significantly by sample size. SIGNIFICANCE OF RESULTS: Each statistical analysis presents its own unique strengths and weaknesses. The information resulting from this research may prove helpful for researchers in palliative care and behavioral medicine in navigating the variety of statistical methods available. Future discussion around best practices in RCT analyses is warranted to compare the relative impact of interventions in a more standardized way.

Psychosocial well-being among patients with malignant pleural mesothelioma.

OBJECTIVES: The investigators conducted a psychosocial needs assessment of mesothelioma patients through self-report measures of quality of life (QOL), coping, depression, and social support. METHODS: Patients with malignant pleural mesothelioma (MPM) (N = 67) completed a battery of assessments at a single timepoint after being approached during routine medical oncology clinic appointments or by letter. RESULTS: Participants were predominately male (70.0%; n = 47) and ranged in age from 35 to 83 years old (M = 65.61, SD = 9.71). Most participants were white (88.0%; n = 59), and 10.0% (n = 7) were identified as Hispanic. The majority were married or living with a partner (93.0%; n = 62) and had some college or more education (64.0%; n = 43). Fourteen percent of participants (n = 11) endorsed significantly elevated depression symptoms. No significant demographic or clinical differences in depressed compared to nondepressed participants were observed, with a trend toward those identifying as Hispanic and those who were divorced as being more likely to be depressed. For the total sample, the most frequently endorsed coping strategies were active coping, emotional support, and acceptance. SIGNIFICANCE OF RESULTS: The present study did not identify any clear correlates of depression or QOL among patients with MPM. This research contributes to the small literature on psychosocial functioning in patients with MPM and provides putative directions for future larger studies and the development of interventions to provide appropriate support to diverse patients with MPM.

How patients with advanced cancer conceptualize prognosis: A phenomenological qualitative inquiry.

BACKGROUND: Despite the importance of accurate prognostic understanding in patients with advanced cancer, there is little consensus around how to conceptualize and measure the multidimensional construct. Most studies focus on single aspects of prognostic understanding (e.g., curability) that clinicians have identified as important; no previous research has asked patients how they define "prognosis." AIM: The present study examined how patients with advanced cancer conceptualize their "prognosis." It also explored how patients assigned value to prognostic information and the impact of prognosis on life perspectives. DESIGN: A phenomenological approach was used to analyze semi-structured interviews with individuals with advanced cancer to examine how patients define prognosis. SETTING/PARTICIPANTS: English and Spanish-speaking patients with advanced cancer (N = 29) were recruited from ambulatory clinics at a comprehensive cancer center in New York City. RESULTS: To conceptualize prognosis, patients focused on concrete medical data, anticipated survival and quality of life, impact on meaningful life events, uncertainty, and physician affect. They discussed the importance of maintaining normalcy despite prognosis, knowledge as a form of coping, information reframing, and altered decision-making as means of coping with prognostic information. CONCLUSIONS: Given the range of ways patients define prognosis and assign value to prognostic information, clinicians should incorporate a thorough assessment of patient information preferences, values, and coping styles when engaging in end-of-life discussions. Trainings should emphasize the importance of nonverbal cues (i.e., affect management, body language) in prognostic disclosure.

On taking up space: a qualitative inquiry of depression in older adults with cancer.

OBJECTIVE: To identify the phenomenology of depression in older adults with cancer (OACs) in order to improve the accuracy of depression screening for this population. METHOD: Inclusion criteria were: ≥70 years old, history of cancer, no cognitive impairment or severe psychopathology. Participants completed a demographic questionnaire, a diagnostic interview, and a qualitative interview. Using a Thematic Content Analysis framework, critical themes, passages, and phrases used by patients to describe their perceptions of depression and how it is experienced were identified. Particular attention was paid to divergences between depressed and non-depressed participants. RESULTS: Among 26 OACs (13 depressed, 13 non-depressed), qualitative analyses revealed four major themes indicative of depression (i.e. anhedonia, reduction in social relationships/loneliness, lack of meaning and purpose, lack of usefulness/feeling like a burden) and four minor themes (i.e. attitude towards treatment, mood, regret/guilt, physical symptoms/limitations). Themes of adaptation and acceptance of symptoms also emerged. CONCLUSIONS: Of the eight themes identified, only two overlap with DSM criteria. This supports the need to develop assessment methods of depression in OACs that are less reliant on DSM criteria and distinct from existing measures. This may improve the ability to identify depression in this population.

Prognostic implications of depression and inflammation in patients with metastatic lung cancer.

Background: Lung cancer-related inflammation is associated with depression. Both elevated inflammation and depression are associated with worse survival. However, outcomes of patients with concomitant depression and elevated inflammation are not known. Materials & methods: Patients with metastatic lung cancer (n = 123) were evaluated for depression and inflammation. Kaplan-Meier plots and Cox proportional hazard models provided survival estimations. Results: Estimated survival was 515 days for the cohort and 323 days for patients with depression (hazard ratio: 1.12; 95% CI: 1.05-1.179), 356 days for patients with elevated inflammation (hazard ratio: 2.85, 95% CI: 1.856-4.388), and 307 days with both (χ2 = 12.546; p < 0.001]). Conclusion: Depression and inflammation are independently associated with inferior survival. Survival worsened by inflammation is mediated by depression-a treatable risk factor.

Is screening for psychosocial risk factors associated with mental health care in older adults with cancer undergoing surgery?

BACKGROUND: Surgery is a notable stressor for older adults with cancer, who often are medically and psychosocially complex. The current study examined rates of preoperative psychosocial risk factors in older adults with cancer who were undergoing elective surgery and the relationship between these risk factors and the provision of mental health services during the postoperative hospitalization. METHODS: A total of 1211 patients aged ≥75 years who were referred to the geriatrics service at a comprehensive cancer center were enrolled. Patients underwent elective surgery with a length of stay of ≥3 days and were followed for at least 30 days after surgery. A comprehensive geriatric assessment was administered as part of routine preoperative care. Bivariate relationships between demographic and surgical characteristics and the preoperative comprehensive geriatric assessment and the receipt of mental health services during the postoperative hospitalization period were examined. Characteristics with bivariate relationships that were significant at the level of P < .10 were entered into a multivariable regression predicting postoperative mental health service use. RESULTS: Approximately one-fifth of the total sample (20.6%) received postoperative mental health services. In multivariable analyses, high distress (P = .007) and poor social support (P = .02) were found to be associated with a greater likelihood of the receipt of mental health services. Of those patients with high distress and poor social support, only approximately one-quarter (24.6%-25.5%) received mental health care. CONCLUSIONS: Distressed older adults and those with low levels of support preoperatively were found to be more likely to receive mental health services after surgery. Nevertheless, less than one-third of these patients received inpatient postoperative mental health care, indicating that barriers to translating screening into the provision of psychosocial services remain.

Confirmatory Factor Analysis of the Center for Epidemiologic Studies Depression Scale in Oncology With Examination of Invariance Between Younger and Older Patients.

Accurate measurement of depressive symptoms in the cancer setting is critical for ensuring optimal quality of life and patient outcomes. The present study compared the one-factor, correlated two-factor, correlated four-factor, and second-order factor models of the Center for Epidemiologic Studies Depression Scale (CES-D), a commonly used measure in oncology settings. Given the importance of adequate psychometric performance of the CES-D across age groups, a second aim was to examine measurement invariance between younger and older adults with cancer. Participants (N = 663) were recruited from outpatient clinics at a large cancer center. Over one-fourth of the sample endorsed clinically significant depressive symptoms (25.9%, n = 165). Confirmatory factor analysis of the CES-D supported the hypothesized correlated four-factor model as the best fit. The second-order factor also demonstrated good fit, but interpretations of the factors were more complex. Factors were highly correlated (range = .38-.91). There was also support for full scalar invariance between age groups, suggesting that regardless of age, respondents endorse the same response category for the same level of the latent trait (i.e., depression) on the CES-D. Taken together, the results suggest that the CES-D is a viable depression screening option for oncology settings and does not require scoring adjustments for respondent age.

Acceptance and Commitment Therapy to Increase Adherence to Penile Injection Therapy-Based Rehabilitation After Radical Prostatectomy: Pilot Randomized Controlled Trial.

INTRODUCTION: Despite the importance of using penile injections as part of a penile rehabilitation program, men have difficulty complying with these programs. AIM: To test a novel psychological intervention based on Acceptance and Commitment Therapy for erectile dysfunction (ACT-ED) to help men utilize penile injections. METHODS: This pilot randomized controlled trial (RCT) recruited men who were beginning a standard care (SC) structured penile rehabilitation program following radical prostatectomy. The SC program instructed patients to use penile injections 2 to 3 times per week. Participants were randomized to SC+ACT-ED or SC+enhanced monitoring (EM). Over 4 months, patients in the SC+ACT-ED group received SC plus 4 ACT sessions and 3 ACT phone calls; those in the EM group received SC plus 7 phone calls from an experienced sexual medicine nurse practitioner. Participants were assessed at study entry and at 4 and 8 months. For this pilot study, the goal was to determine initial efficacy (ie, effect sizes, where d = 0.2 is small, d = 0.5 is medium, and d = 0.8 is large). MAIN OUTCOME MEASURE: Primary outcomes were feasibility and use of penile injections. Secondary outcomes were ED treatment satisfaction (ie, Erectile Dysfunction Inventory of Treatment Satisfaction, or EDITS), sexual Self-Esteem and Relationship (SEAR) quality, sexual bother (SB), and prostate cancer treatment regret. RESULTS: The 53 participants were randomized (ACT, n = 26; EM, n = 27). The study acceptance rate was 61%. At 4 months, the ACT-ED group utilized more penile injections per week (1.7) compared to the EM group (0.9) (d = 1.25; P = .001) and was more adherent to penile rehabilitation compared to the EM group (ACT, 44%; EM, 10%; relative risk [RR], 4.4; P = .02). These gains were maintained at 8 months for injections per week (ACT, 1.2; EM, 0.7; d = 1.08; P = .03) and approached significance for adherence (ACT, 18%; EM, 0%; P = .10). At 4 months, ACT-ED, compared to EM, reported moderate effects for greater satisfaction with ED treatment (d = 0.41; P = .22), greater sexual self-esteem (d = 0.54; P = .07) and sexual confidence (d = 0.48; P = .07), lower sexual bother (d = 0.43; P = .17), and lower prostate cancer treatment regret (d = 0.74; P = .02). At 8 months, moderate effects in favor of ACT-ED were maintained for greater sexual self-esteem (d = 0.40; P = .19) and less treatment regret (d = 0.47; P = .16). CLINICAL IMPLICATIONS: ACT concepts may help men utilize penile injections and cope with the effects of ED. STRENGTHS AND LIMITATIONS: Strengths include use of an innovative intervention utilizing ACT concepts and pilot RCT. Limitations include the pilot nature of the study (eg, small samples size, lack of statistical power). CONCLUSION: ACT-ED is feasible and significantly increases the use of penile injections. ACT-ED also shows promise (moderate effects) for increasing satisfaction with penile injections and sexual self-esteem while decreasing sexual bother and prostate cancer treatment regret. Nelson CJ, Saracino RM, Napolitano S, et al. Acceptance and Commitment Therapy to Increase Adherence to Penile Injection Therapy-Based Rehabilitation After Radical Prostatectomy: Pilot Randomized Controlled Trial. J Sex Med 2019; 19:1398-1408.

Cancer and Aging: Reflections for Elders (CARE): A pilot randomized controlled trial of a psychotherapy intervention for older adults with cancer.

OBJECTIVE: Cancer and Aging: Reflections for Elders (CARE) is a novel, telephone-delivered intervention designed to alleviate distress in older cancer patients. This pilot randomized controlled trial tested the feasibility and initial efficacy of CARE, drawing from age-appropriate developmental themes and well-established coping theory. METHOD: Eligible patients were ≥70 years old; ≥6 months post-diagnosis of lung, prostate, breast, lymphoma, or gynecological cancer; on active cancer treatment or within 6 months of ending cancer treatment; and had elevated scores on the Distress Thermometer (≥4) or Hospital Anxiety and Depression Scale (≥6). Participants completed five sessions of psychotherapy over 7 weeks with assessments at study entry, post-intervention, and 2 months post-intervention. Primary outcomes were feasibility and initial efficacy on anxiety and depression; secondary outcomes included demoralization, coping, loneliness, and spiritual well-being. RESULTS: Fifty-nine participants were randomized to either the CARE arm (n = 31) or the enhanced Social Work Control arm (n = 28). The intervention was feasible and tolerable, meeting a priori criteria for rates of eligibility, acceptance, retention, assessment, and treatment fidelity. Upon completion of the intervention, participants in the CARE arm demonstrated lower mean depression scores (d = 0.58 [CI: 0.04-1.12], P = 0.01) and trended towards increased coping-planning (d = 0.30 [CI: -0.83 to 0.24], P = 0.18). Promising trends in anxiety (d = 0.41 [CI: -0.17 to 0.98], P = 0.10) emerged at 2 months post-intervention; effects for coping-planning dissipated. CONCLUSION: These pilot data suggest the CARE intervention is feasibly delivered, potentially impacts important psychosocial variables, and is accessible for older, frail patients with cancer. Future research will evaluate this intervention on a larger scale.

Psychotherapy at the End of Life.

Dr. Elisabeth Kübler-Ross is credited as one of the first clinicians to formalize recommendations for working with patients with advanced medical illnesses. In her seminal book, On Death and Dying, she identified a glaring gap in our understanding of how people cope with death, both on the part of the terminally ill patients that face death and as the clinicians who care for these patients. Now, 50 years later, a substantial and ever-growing body of research has identified "best practices" for end of life care and provides confirmation and support for many of the therapeutic practices originally recommended by Dr. Kübler-Ross. This paper reviews the empirical study of psychological well-being and distress at the end of life. Specifically, we review what has been learned from studies of patient desire for hastened death and the early debates around physician assisted suicide, as well as demonstrating how these studies, informed by existential principles, have led to the development of manualized psychotherapies for patients with advanced disease. The ultimate goal of these interventions has been to attenuate suffering and help terminally ill patients and their families maintain a sense of dignity, meaning, and peace as they approach the end of life. Two well-established, empirically supported psychotherapies for patients at the end of life, Dignity Therapy and Meaning Centered Psychotherapy are reviewed in detail.

The feasibility of a group stress management Liver SMART intervention for patients with end-stage liver disease: A pilot study.

OBJECTIVE: Structured, empirically supported psychological interventions are lacking for patients who require organ transplantation. This stage IA psychotherapy development project developed and tested the feasibility, acceptability, tolerability, and preliminary efficacy of an 8-week group cognitive behavioral stress management intervention adapted for patients with end-stage liver disease awaiting liver transplantation. METHOD: Twenty-nine English-speaking United Network for Organ Sharing-registered patients with end-stage liver disease from a single transplantation center enrolled in 8-week, group cognitive-behavioral liver stress management and relaxation training intervention adapted for patients with end-stage liver disease. Patients completed pre- and postintervention surveys that included the Beck Depression Inventory II and the Beck Anxiety Inventory. Feasibility, acceptability, tolerability, and preliminary efficacy were assessed.ResultAttendance rate was 69.40%. The intervention was rated as "good" to "excellent" by 100% of participants who completed the postintervention survey in teaching them new skills to relax and to cope with stress, and by 94.12% of participants in helping them feel supported while waiting for a liver transplant. No adverse events were recorded over the course of treatment. Attrition was 13.79%. Anxious and depressive symptoms were not statistically different after the intervention.Significance of resultsThe liver stress management and relaxation training intervention is feasible, acceptable, and tolerable to end-stage liver disease patients within a transplant clinic setting. Anxious and depressive symptoms remained stable postintervention. Randomized controlled trials are needed to study the intervention's effectiveness in this population.

Individual meaning-centered psychotherapy for the treatment of psychological and existential distress: A randomized controlled trial in patients with advanced cancer.

BACKGROUND: Patients with advanced cancer have high rates of psychological distress, including depression, anxiety, and spiritual despair. This study examined the effectiveness of individual meaning-centered psychotherapy (IMCP) in comparison with supportive psychotherapy (SP) and enhanced usual care (EUC) in improving spiritual well-being and quality of life and reducing psychological distress in patients with advanced cancer. METHODS: Patients (n = 321) were randomly assigned to IMCP (n = 109), SP (n = 108), or EUC (n = 104). Assessments were conducted at 4 time points: before intervention, midtreatment (4 weeks), 8 weeks after treatment, and 16 weeks after treatment. RESULTS: Significant treatment effects (small to medium in magnitude) were observed for IMCP, in comparison with EUC, for 5 of 7 outcome variables (quality of life, sense of meaning, spiritual well-being, anxiety, and desire for hastened death), with Cohen's d ranging from 0.1 to 0.34; no significant improvement was observed for patients receiving SP (d < 0.15 and P > .05 for all variables). The effect of IMCP was significantly greater than the effect of SP for quality of life and sense of meaning (d = 0.19) but not for the remaining study variables. CONCLUSIONS: This study provides further support for the efficacy of IMCP as a treatment for psychological and existential/spiritual distress in patients with advanced cancer. Significant treatment effects (small to moderate effect sizes) were observed in comparison with usual care, and somewhat more modest differences in improvement (small effect sizes) were observed in comparison with SP. Thus, the benefits of meaning-centered psychotherapy appear to be unique to the intervention and highlight the importance of addressing existential issues with patients approaching the end of life. Cancer 2018. © 2018 American Cancer Society.

Geriatric palliative care: Meeting the needs of a growing population.

The implementation of effective geriatric palliative care (PC) services will be increasingly important as the number of patients ages ≥65 years continues to grow. However, literature characterizing the utilization of PC services by older adults remains scant. The objective of these analyses was to characterize the nature and outcomes of PC services for older adults. A retrospective analysis of records of inpatient PC consultations provided to patients ≥65 years at an academic hospital was performed (N = 743). Logistic regressions identified factors associated with goals of care discussions (GOC), end-of-life (EOL) coordination, and hospital readmission. Differences between older adult subgroups (i.e., 65-84 years and 85 years and older) were also examined. Discharge to home was associated with higher odds of readmission and discharge to hospice or having a GOC discussion was associated with lower odds of readmission. Those patients who were 85 years or older were significantly less likely to have cancer or to be referred for pain management, and more likely to be referred for GOC discussions and discharged to hospice. This study revealed dynamic factors associated with PC consultation for older adults. GOC discussions in initial PC consultations for older patients might reduce the odds of hospital readmission. Additionally, the needs of patients ages 85 and older appear distinct from the traditional PC cancer model.

Patient-Reported Physical Function Measures in Cancer Clinical Trials.

Patient-reported outcomes (PROs) are increasingly used to monitor treatment-related symptoms and physical function decrements in cancer clinical trials. As more patients enter survivorship, it is important to capture PRO physical function throughout trials to help restore pretreatment levels of function. We completed a systematic review of PRO physical function measures used in cancer clinical trials and evaluated their psychometric properties on the basis of guidelines from the US Food and Drug Administration. Five databases were searched through October 2015: PubMed/MEDLINE, EMBASE, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Health and Psychosocial Instruments, and Cochrane. From an initial total of 10,233 articles, we identified 108 trials that captured PRO physical function. Within these trials, approximately 67% used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and 25% used the Medical Outcomes Study Short Form 36. Both the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Medical Outcomes Study Short Form 36 instruments generically satisfy most Food and Drug Administration requirements, although neither sought direct patient input as part of item development. The newer Patient-Reported Outcomes Measurement Information System physical function short form may be a brief, viable alternative. Clinicians should carefully consider the psychometric properties of these measures when incorporating PRO instrumentation into clinical trial design to provide a more comprehensive understanding of patient function.

Assessing depression in a geriatric cancer population.

OBJECTIVE: To examine the ability of three popular self-report measures of depression to assess depression in a geriatric cancer setting. METHOD: Cancer patients 70 years or older and on active treatment completed the Geriatric Depression Scale-Short Form, the Hospital Anxiety and Depression Scale, and the Center for Epidemiological Studies Depression Scale-Revised, and were interviewed using the depression module of the Structured Clinical Interview for DSM disorders (SCID) as the 'gold standard.' Analyses included calculating internal consistency, ROC curves, and the sensitivity and specificity to detect major depression (MDD) or minor depression (i.e. subthreshold depression). RESULTS: In a sample of 201 cancer patients (85% White; 64% completed college degree or higher), all three of the self-report measures produced adequate internal consistency and predicted depression greater than chance. However, the published cutoff scores for detecting MDD produced inadequate sensitivity, suggesting these scores will miss as many as 33%-83% of geriatric cancer patients who are depressed. Revised cutoff scores were lower than published cutoff scores. CONCLUSION: Although these measures produced good internal consistency and were better than chance at predicting depression in a geriatric cancer sample, the published cutoff scores for these measures did not perform well in predicting MDD nor minor depression. Of the three measures, the CES-D appeared to have the most utility. This data suggests that these popular screening measures may be inadequate for reliably identifying depression in a geriatric cancer population. Researchers and clinicians, therefore, should use caution when selecting depression measures for geriatric cancer patients and consider using the lower cut-off scores presented here.

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review.

PURPOSE: Symptomatic adverse events (AEs) are monitored by clinicians as part of all US-based clinical trials in cancer via the U.S. National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) for the purposes of ensuring patient safety. Recently, there has been a charge toward capturing the patient perspective for those AEs amenable to patient self-reporting via patient-reported outcomes (PRO). The aim of this review was to summarize the empirically reported association between analogous CTCAE and PRO ratings. METHODS: A systematic literature search was conducted using PubMed, EMBASE, Web of Science, and Cochrane databases through July 2015. From a total of 5658 articles retrieved, 28 studies met the inclusion criteria. RESULTS: Across studies, patients were of mixed cancer types, including anal, breast, cervical, chronic myeloid leukemia, endometrial, hematological, lung, ovarian, pelvic, pharyngeal, prostate, and rectal. Given this mixture, the AEs captured were variable, with many common across studies (e.g., dyspnea, fatigue, nausea, neuropathy, pain, vomiting), as well as several that were disease-specific (e.g., erectile dysfunction, hemoptysis). Overall, the quantified association between CTCAE and PRO ratings fell in the fair to moderate range and had a large variation across the majority of studies (n = 21). CONCLUSIONS: The range of measures used and symptoms captured varied greatly across the reviewed studies. Regardless of concordance metric employed, reported agreement between CTCAE and PRO ratings was moderate at best. To assist with reconciliation and interpretation of these differences toward ultimately improving patient care, an important next step is to explore approaches to integrate PROs with clinician reporting of AEs.

Towards a new conceptualization of depression in older adult cancer patients: a review of the literature.

OBJECTIVES: Identifying depression in older adults with cancer presents a set of unique challenges, as it combines the confounding influences of cancer and its treatment with the developmental changes associated with aging. This paper reviews the phenomenology of depression in older adults, and individuals diagnosed with cancer. METHOD: PsychInfo, PubMed, Web of Science, and Google Scholar databases were searched for English-language studies addressing the phenomenology, symptoms, or assessment of depression in older adults and those with cancer. RESULTS: The Diagnostic and Statistical Manual for Mental Disorders (DSM) criteria that appear to be relevant to both older adults and cancer patients are anhedonia, concentration difficulties, sleep disturbances, psychomotor retardation/agitation, and loss of energy. Possible alternative criteria that may be important considerations included constructs such as loss of purpose, loneliness, and irritability in older adults. Among cancer patients, tearfulness, social withdrawal, and not participating in treatment despite ability to do so were identified as potentially important symptoms. CONCLUSIONS: Current DSM criteria may not adequately assess depression in older cancer patients and alternative criteria may be important to inform the understanding and identification of depression in this population. Enhancing diagnostic accuracy of depression is important as both the over-diagnosis and under-diagnosis is accompanied with significant costs. Thus, continued research exploring the phenomenology and identifying effective indicators of depression in older cancer patients is needed.

The level of association between functional performance status measures and patient-reported outcomes in cancer patients: a systematic review.

PURPOSE: The process of assessing patient symptoms and functionality using patient-reported outcomes (PROs) and functional performance status (FPS) is an essential aspect of patient-centered oncology research and care. However, PRO and FPS measures are often employed separately or inconsistently combined. Thus, the purpose of this study was to conduct a systematic review of the level of association between PRO and FPS measures to determine their differential or combined utility. METHODS: A systematic search was conducted using five databases (1966 to February 2014) to identify studies that described an association between PRO and FPS. Studies were excluded if they were non-cancer specific, did not include adults aged 18 or older, or were review articles. Publications were selected for review by consensus among two authors, with a third author arbitrating as needed. RESULTS: A total of 18 studies met inclusion criteria. FPS was primarily assessed by clinicians using the ECOG Performance Status or Karnofsky Performance Status measures. PROs were captured using a variety of measures, with numerous domains assessed (e.g., pain, fatigue, and general health status). Concordance between PROs and FPS measures was widely variable, falling in the low to moderate range (0.09-0.72). CONCLUSIONS: Despite consistency in the method of capture of PROs or FPS, domain capture varied considerably across reviewed studies. Irrespective of the method of capturing PROs or FPS, the quantified level of association between these two areas was moderate at best, providing evidence that FPS and PRO assessments offer unique information to assist clinicians in their decision-making.

Protocol for a randomized controlled trial of brief behavioral activation among older adult cancer survivors.

INTRODUCTION: As many as 35% of older adult cancer survivors (OACS; i.e., ≥65 years old) have clinically significant depression. OACS often experience fatigue, mild cognitive impairment, and increased medical comorbidities post-cancer that make them susceptible to depression. Behavioral activation (BA) is an empirically supported depression treatment in geriatric psychiatry that guides individuals to reengage in pleasurable and rewarding activities and has great potential for addressing the needs of OACS. This manuscript presents the protocol for a pilot randomized controlled trial (RCT) testing the efficacy of a brief BA intervention adapted to address the needs of OACS (BBA-OACS) by telephone and videoconference delivery. MATERIALS AND METHODS: An RCT will be conducted at Memorial Sloan Kettering Cancer Center (MSK) in New York City. Participants will be randomized to either BA as a target intervention or supportive psychotherapy (SP) as a standard of care control intervention for outpatient oncology. The target intervention includes 10 weekly sessions of BA consisting of psychoeducation about depression and the rationale for BA, life areas and values assessment, compilation of a list of enjoyable and important activities across values, activity scheduling, and self-monitoring of satisfaction and mood. The standard of care control intervention includes 10 weekly sessions of SP consisting of reassurance, guidance, encouragement, and support for patients with cancer. OACS who have a history of cancer, report elevated depressive symptoms, are fluent in English, and can communicate via telephone or videoconference will be recruited from the MSK Survivorship Clinics across all disease types. Seventy participants will be recruited for the study (10 training cases, 30 in each RCT arm). The primary aim is to evaluate implementation outcomes (i.e., acceptability, feasibility, and fidelity) of BA, relative to SP, for cancer survivorship. The secondary aim is to determine the preliminary effects of BA on depressive symptoms (primary outcome), anxiety, coping, and increased activity level (secondary outcomes) compared to SP. Participants will be asked to complete a set of three surveys pre- and post-intervention. DISCUSSION: If successful, BBA-OACS would provide frontline clinicians with an accessible, evidence-based treatment for OACS. Future research will evaluate the efficacy of BA in a larger trial and its impact on depression and other healthcare outcomes. TRIAL REGISTRATION: This study is registered under ClinicalTrials.gov (ID NCT05574127).