Participation Restrictions in Breast Cancer Survivors
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).
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Participation Restrictions in Young-Middle Adult Rural Breast Cancer Survivors|
- Feasibility [ Time Frame: six weeks ] [ Designated as safety issue: No ]
- 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).
- Functional status [ Time Frame: baseline, six weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]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.
- Quality of life [ Time Frame: baseline, six weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]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.
- Affective symptoms [ Time Frame: baseline, six weeks, 12 weeks, 18 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225328
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Mark T Hegel, PhD||Dartmouth-Hitchcock Medical Center|