- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00429286
Preserving Function in Breast Cancer Patients
October 24, 2011 updated by: Dartmouth-Hitchcock Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Breast cancer patients undergoing chemotherapy at the Norris Cotton Cancer Center in Lebanon, NH.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mark T Hegel, PhD, Dartmouth-Hitchcock Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
January 29, 2007
First Submitted That Met QC Criteria
January 30, 2007
First Posted (Estimate)
January 31, 2007
Study Record Updates
Last Update Posted (Estimate)
October 26, 2011
Last Update Submitted That Met QC Criteria
October 24, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R03CA124200-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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