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

ABSTRACT: 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.

SUBMITTER: Nelson CJ

PROVIDER: S-EPMC6476184 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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

Nelson Christian J CJ Saracino Rebecca M RM Roth Andrew J AJ Harvey Elizabeth E Martin Anne A Moore Mark M Marcone Dana D Poppito Shannon R SR Holland Jimmie J

Psycho-oncology 20181107 1

<h4>Objective</h4>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.<h4>Method</h4>Eligible patients were ≥70 years old; ≥6 months post-diagnosis of lung, prostate, breast, lymphoma, or gynecological cancer; on active cance ...[more]

PMID: 30296337

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Project description:BackgroundOncologists often struggle with managing the unique care needs of older adults with cancer. This study sought to determine the feasibility of delivering a transdisciplinary intervention targeting the geriatric-specific (physical function and comorbidity) and palliative care (symptoms and prognostic understanding) needs of older adults with advanced cancer.MethodsPatients aged ?65 years with incurable gastrointestinal or lung cancer were randomly assigned to a transdisciplinary intervention or usual care. Those in the intervention arm received 2 visits with a geriatrician, who addressed patients' palliative care needs and conducted a geriatric assessment. We predefined the intervention as feasible if >70% of eligible patients enrolled in the study and >75% of eligible patients completed study visits and surveys. At baseline and week 12, we assessed patients' quality of life (QoL), symptoms, and communication confidence. We calculated mean change scores in outcomes and estimated intervention effect sizes (ES; Cohen's d) for changes from baseline to week 12, with 0.2 indicating a small effect, 0.5 a medium effect, and 0.8 a large effect.ResultsFrom February 2017 through June 2018, we randomized 62 patients (55.9% enrollment rate [most common reason for refusal was feeling too ill]; median age, 72.3 years; cancer types: 56.5% gastrointestinal, 43.5% lung). Among intervention patients, 82.1% attended the first visit and 79.6% attended both. Overall, 89.7% completed all study surveys. Compared with usual care, intervention patients had less QoL decrement (-0.77 vs -3.84; ES = 0.21), reduced number of moderate/severe symptoms (-0.69 vs +1.04; ES = 0.58), and improved communication confidence (+1.06 vs -0.80; ES = 0.38).ConclusionsIn this pilot trial, enrollment exceeded 55%, and >75% of enrollees completed all study visits and surveys. The transdisciplinary intervention targeting older patients' unique care needs showed encouraging ES estimates for enhancing patients' QoL, symptom burden, and communication confidence.

Project description:BACKGROUND:Oncology clinicians often struggle with managing medications and vaccinations in older adults with cancer. We sought to demonstrate the feasibility and preliminary efficacy of integrating pharmacists into the care of older adults with cancer to enhance medication management and vaccination administration. METHODS:We randomly assigned patients aged ?65 years with breast, gastrointestinal, or lung cancer receiving first-line chemotherapy to the pharmacy intervention or usual care. Patients assigned to the intervention met with a pharmacist once during their second or third chemotherapy infusion. We obtained information about patients' medications and vaccinations via patient report and from the electronic health record (EHR) at baseline and week 4. We determined the number of discrepant (difference between patient report and EHR) and potentially inappropriate (Beers Criteria assessed by nonintervention pharmacists blinded to group assignment) medications. We defined the intervention as feasible if >75% of patients enrolled in the study and received the pharmacist visit. RESULTS:From January 17, 2017, to October 27, 2017, we enrolled and randomized 60 patients (80.1% of patients approached). Among those assigned to the intervention, 96.6% received the pharmacist visit. At week 4, intervention patients had higher rates of acquiring vaccinations for pneumonia (27.6% vs. 0.0%, p = .002) and influenza (27.6% vs. 0.0%, p = .002) compared with usual care. Intervention patients had fewer discrepant (5.82 vs. 8.07, p = .094) and potentially inappropriate (3.46 vs. 4.80, p = .069) medications at week 4, although differences were not significant. CONCLUSION:Integrating pharmacists into the care of older adults with cancer is feasible with encouraging preliminary efficacy for enhancing medication management and improving vaccination rates. IMPLICATIONS FOR PRACTICE:Results of this study showed the feasibility, acceptability, and preliminary efficacy of an intervention integrating pharmacists into the care of older adults with cancer. Notably, patients assigned to the intervention had fewer discrepant medications and were more likely to acquire vaccinations for pneumonia and influenza. Importantly, this work represents the first randomized controlled trial involving the integration of pharmacists into the outpatient oncologic care of older adults with cancer. In the future, a larger randomized trial is needed to demonstrate the efficacy of this care model to enhance medication management and improve vaccination outcomes for older patients with cancer.

Project description:BackgroundThere is a need to improve psychotherapeutic approaches to treatment for vulnerable older adults with depression in terms of both clinical practice and health care supply. Against this background, PSY-CARE is testing the feasibility and effectiveness of outpatient psychotherapy for home-living older adults in need of care with depression in Berlin, Germany, and neighboring suburban areas.MethodsIn a two-arm single-center pragmatic randomized controlled trial (RCT), manual-guided outpatient psychotherapy will be compared to brief psychosocial counseling. The study population will be compromised of older adults with clinically significant depressive symptoms who have a long-term care grade, as assessed by the German compulsory state nursing care insurance. In the intervention group, individual cognitive-behavioral psychotherapy tailored to the specific needs of this population will be offered by residential psychotherapists as part of the regular healthcare service. In the active control group, participants will receive individual psychosocial telephone counselling and a self-help guide. The planned sample size is N = 130 (n = 65 participants per group). The reduction of depressive symptoms (primary outcome) as well as the maintaining of activities of daily living, quality of life, and functioning will be assessed with questionnaires provided at baseline, after the end of the intervention and after three months. Feasibility and process evaluation will be conducted qualitatively based on documentation and interviews with psychotherapists, gatekeepers and the participants.DiscussionPSY-CARE investigates the potentials and limitations of providing outpatient psychotherapeutic treatment meeting the demands of vulnerable home-living older adults with depression under the real conditions of the health care system. The study will provide practical implications to improve access to and quality of outpatient psychotherapy for this poorly supplied population.Trial registrationThe trial is registered at ISRCTN55646265 ; February 15, 2019.

Dataset Information

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

Publications

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

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