Preserving Function in Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00429286
First received: January 29, 2007
Last updated: October 24, 2011
Last verified: October 2011

January 29, 2007
October 24, 2011
May 2007
August 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00429286 on ClinicalTrials.gov Archive Site
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Preserving Function in Breast Cancer Patients
Preserving Function in Rural Breast Cancer Patients Undergoing Chemotherapy

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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Breast cancer patients undergoing chemotherapy at the Norris Cotton Cancer Center in Lebanon, NH.

Breast Cancer
Behavioral: Problem Solving Training
A systematic cognitive-behavioral intervention teaching problem solving skills for addressing functional impairment related to breast cancer and its treatment.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00429286
1 R03 CA124200-01
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
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Principal Investigator: Mark T Hegel, PhD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP