Participation Restrictions in Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Behavioral activation/problem-solving (BA/PS)

• Registration Number: NCT01225328
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-19
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Status Verified: 2014-02
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

1. Female breast cancer patient stages I-III.
2. Age 18-59.
3. Completion of definitive breast cancer treatment (i.e., subsequent to loco-regional surgical treatment and completion of adjuvant or neo-adjuvant chemotherapy with or without radiation) within the past 3-6 months.
4. Screen positive for a moderate or worse level of participation restriction (Work and Social Adjustment Scale score > 10) within 6 months following cancer treatment.
5. English speaking.
6. Have a land-based phone or reliable cell phone reception.

Exclusion Criteria

1. Non-correctable hearing loss.
2. Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
3. Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder) or active substance abuse.
4. Medical record documentation of a physical disorder with associated functional impairment (e.g., Parkinson's disease, stroke, congestive heart failure, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Behavioral activation/problem-solving (BA/PS)	Telephone-delivered Behavioral Activation/Problem Solving (BA/PS) intervention

Primary Outcome Measures

Name	Time	Method
Feasibility	six weeks	* 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).

Secondary Outcome Measures

Name	Time	Method
Affective symptoms	baseline, six weeks, 12 weeks, 18 weeks	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.
Quality of life	baseline, six weeks, 12 weeks, 18 weeks	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.
Functional status	baseline, six weeks, 12 weeks, 18 weeks	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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States