Participation Restrictions in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Participation Restrictions in Young-Middle Adult Rural Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225328
• Other study ID #: D1032
• Status: Completed
• Phase: N/A
• First received: October 19, 2010
• Last updated: December 18, 2014
• Start date: October 2010
• Est. completion date: April 2014

Study information

• Verified date: February 2014
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Behavioral activation/problem-solving (BA/PS)
Six weekly telephone sessions to train participant in BA/PS procedures

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	six weeks	No
Secondary	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.	baseline, six weeks, 12 weeks, 18 weeks	No
Secondary	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.	baseline, six weeks, 12 weeks, 18 weeks	No
Secondary	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.	baseline, six weeks, 12 weeks, 18 weeks	No