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Completed

NCT Number: NCT00429286

Preserving Function in Breast Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Problem Solving Training

Behavioral

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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Preserving Function in Rural Breast Cancer Patients Undergoing Chemotherapy

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 31, 2007
Registry last updated
Oct 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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