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NCT00429286 · ClinicalTrials.gov registry record

Preserving Function in Breast Cancer Patients

A clinical trial of Breast Cancer, sponsored by Dartmouth-Hitchcock Medical Center.

Completed
Registry status
30
Enrollment target
1
Study location

NCT00429286 is a study of Breast Cancer that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00429286, a study of Breast Cancer, has completed, sponsored by Dartmouth-Hitchcock Medical Center.

COMPLETED
Registry status
30 participants
Enrollment target
1
Study location

Study 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 d

Conditions Studied

Interventions

  • BEHAVIORAL Problem Solving Training

Study Locations (1)

New Hampshire

  • Dartmouth-Hitchcock Medical Center - Lebanon

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2007-05
Est. Completion 2009-08

Sponsor

Dartmouth-Hitchcock Medical Center

427 total trials

What the Registry Record Tells You About NCT00429286

The ClinicalTrials.gov registry entry for NCT00429286 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Problem Solving Training is the first listed.

NCT00429286 reports 1 study location spanning 1 distinct geographic area - top geographies include New Hampshire.

Frequently Asked Questions

What is clinical trial NCT00429286 about?

NCT00429286 is a clinical study titled "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...

What is the current status of trial NCT00429286?

This trial is currently completed. The enrollment target is 30 participants. The study started on 2007-05. Estimated completion is 2009-08.

What conditions does trial NCT00429286 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00429286?

The interventions under investigation include: Problem Solving Training (BEHAVIORAL).

Who is sponsoring clinical trial NCT00429286?

This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00429286 being conducted?

This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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