An interventional study of Behavioral activation/problem-solving (BA/PS) in Breast Cancer, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2014-12-19.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable and Interventional
This project will develop and preliminarily evaluate an intervention to assist young-middle adult rural breast cancer survivors to overcome functional impairments related to their cancer treatment. Younger breast cancer survivors (below age 60) have ongoing family, social and vocational responsibilities and recreational interests and are at increased risk of developing long-term difficulties performing these valued activities (participation restrictions). Rural cancer survivors are medically underserved and due to distance and geographic isolation face significant barriers to accessing traditional rehabilitation services. Alternative rehabilitation approaches are sorely needed for this population. Based on previous research with cancer and other medical populations a working draft of a treatment manual using a telephone-delivered Behavioral Activation and Problem Solving (BA/PS) intervention has been designed. Prior to testing the intervention in a randomized clinical trial, additional work must be completed. The specific aims of this study are to a. refine the BA/PS treatment manual, b. develop and apply treatment integrity measures for the BA/PS manual, c. assess participation restrictions and associated outcomes, d. preliminarily assess the immediate and maintenance effects of BA/PS, and e. examine mediators and moderators of BA/PS effects based on our "Self Regulation" model of functional recovery. 188 young-middle adult breast cancer survivors will be screened for participation restrictions following cancer treatment and 40 survivors with participation restrictions will receive BA/PS delivered by phone. BA/PS participants will be assessed for treatment effectiveness and interviewed regarding their experiences during treatment to provide information for refining the manual. The long-term objective of this line of research is to develop effective and feasible treatments for the medical and psychosocial consequences of cancer and its treatment in medically underserved cancer survivors (e.g., rural populations).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 24 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
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Exclusion Criteria:
Telephone-delivered Behavioral Activation/Problem Solving (BA/PS) intervention
Behavioral: Behavioral activation/problem-solving (BA/PS)
Six weekly telephone sessions to train participant in BA/PS procedures
Feasibility
* of patients evaluated for enrollment / # of patients approached. * of patients meeting eligibility criteria / # of patients evaluated. * of patients enrolled / # of patients meeting eligibility criteria * of patients completing 6 weeks of BA/PS treatment. * of patients completing each study assessment point (T1, T2, T3, T4).
Time frame: six weeks
Functional status
The Medical Outcomes Short Form-36 (MOS SF-36) consists of eight scales (physical functioning, role limitations - physical, role limitations - emotional, vitality, well being, social functioning, bodily pain, and general health) and two standardized component summary scores (physical and mental). The physical and mental factors account for 80-85% of the variance in the scales. We will use the Physical Component Summary (PCS) Score as the primary outcome measure.
Time frame: baseline, six weeks, 12 weeks, 18 weeks
Quality of life
The Functional Assessment of Cancer Therapy-Breast Cancer + Arm Morbidity (FACT-B+4) is a 41-item self-report measure of health-related quality of life specifically designed for breast cancer patients.
Time frame: baseline, six weeks, 12 weeks, 18 weeks
Affective symptoms
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report measure of depressive and anxiety symptoms specifically designed for medical patients. The HADS contains only the cognitive symptoms of depression and anxiety, thus eliminating the somatic symptoms that are poor indicators of psychiatric distress in the medically ill.
Time frame: baseline, six weeks, 12 weeks, 18 weeks
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center