Participation Restrictions in Breast Cancer Survivors

NCT01225328 | Completed DMC

• 1 other identifier: D1032
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Functional status

  baseline, six weeks, 12 weeks, 18 weeks

• Quality of life

  baseline, six weeks, 12 weeks, 18 weeks

• Affective symptoms

  baseline, six weeks, 12 weeks, 18 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Telephone-delivered Behavioral Activation/Problem Solving (BA/PS) intervention

Behavioral: Behavioral activation/problem-solving (BA/PS)

Interventions

Behavioral activation/problem-solving (BA/PS) BEHAVIORAL

Six weekly telephone sessions to train participant in BA/PS procedures

Intervention

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female breast cancer patient stages I-III.
• Age 18-59.
• 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.
• Screen positive for a moderate or worse level of participation restriction (Work and Social Adjustment Scale score \> 10) within 6 months following cancer treatment.
• English speaking.
• Have a land-based phone or reliable cell phone reception.

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark T Hegel, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 21, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 19, 2014

Record last verified: 2014-02

Locations

US (1)