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Preserving Function in Breast Cancer Patients

NCT ID: NCT00429286

Last Updated: 2011-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-08-31

Brief Summary

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Breast cancer patients experience functional limitations related to the cancer and treatment side effects. Early functional limitations affect short- and long-term quality of life, and may lead to long-term complications. Patients living in rural areas are at particular risk because they do not have easy access to services. Therefore, early intervention is indicated to have an impact on the overall public health. Problem solving training (PST) is a standardized manual driven intervention that may be ideally suited to assist breast cancer patients to preserve their valued activities and to comply with recommended symptom management regimens (e.g., physical therapy, aerobic exercise and relaxation/guided imagery) that improve function. Telephone-based PST provided from a centralized location (such as the comprehensive cancer center) may improve access and outcomes in a cost-effective manner. We propose to conduct a feasibility study of a PST intervention with 30 rural breast cancer patients undergoing adjuvant treatment randomly assigned to PST or to usual care. The intervention group will receive weekly phone-based PST sessions for six consecutive weeks. The specific aims of this R03 small grant application are to:1) Test the feasibility of enrolling and retaining newly diagnosed breast cancer patients in a clinical trial to assess telephone-based PST. 2) Collect preliminary data on outcome measures of function to determine effect size estimates that will inform power analyses for a full scale randomized controlled study. Primary outcome measures will be acceptance rates for enrollment in the study, retention rates across both intervention arms, and satisfaction levels with the PST intervention. Assessments will be conducted at baseline, and at six weeks (end of PST intervention) and 3 months following baseline. The long-term goal of this line of investigation is to develop practical, widely applicable rehabilitation models of care to preserve function and decrease distress in cancer patients undergoing treatment.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Problem Solving Training

A systematic cognitive-behavioral intervention teaching problem solving skills for addressing functional impairment related to breast cancer and its treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Females, age \> 18 years.
2. First breast cancer diagnosis, Stages 1-3.
3. Beginning the second chemotherapy cycle.
4. English speaking and literate.

Exclusion Criteria

1. Previous or concurrent malignancy, except for non-melanotic skin cancers.
2. Lifetime diagnosis of schizophrenia or bipolar disorder.
3. Moderate-severe cognitive impairment indicated by a score \< 3 on a 6-item cognitive screener.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark T Hegel, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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1R03CA124200-01

Identifier Type: NIH

Identifier Source: org_study_id

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