Preserving Function in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00429286
Recruitment Status : Completed
First Posted : January 31, 2007
Last Update Posted : October 26, 2011
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: Problem Solving Training

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preserving Function in Rural Breast Cancer Patients Undergoing Chemotherapy
Study Start Date : May 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Intervention Details:
    Behavioral: Problem Solving Training
    A systematic cognitive-behavioral intervention teaching problem solving skills for addressing functional impairment related to breast cancer and its treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Breast cancer patients undergoing chemotherapy at the Norris Cotton Cancer Center in Lebanon, NH.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00429286

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Principal Investigator: Mark T Hegel, PhD Dartmouth-Hitchcock Medical Center

Additional Information:
Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00429286     History of Changes
Other Study ID Numbers: 1R03CA124200-01 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2007    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: October 2011

Keywords provided by Dartmouth-Hitchcock Medical Center:
Health Services Research

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases