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NCT01225328 · ClinicalTrials.gov registry record · NA
Participation Restrictions in Breast Cancer Survivors
A NA study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT01225328: Completed NA study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT01225328 is a NA study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01225328, a NA study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
This project will develop and preliminarily evaluate an intervention to assist young-middle adult rural breast cancer survivors to overcome functional impairments related to their cancer treatment. Younger breast cancer survivors (below age 60) have ongoing family, social and vocational responsibilities and recreational interests and are at increased risk of developing long-term difficulties performing these valued activities (participation restrictions). Rural cancer survivors are medically underserved and due to distance and geographic isolation face significant barriers to accessing traditional rehabilitation services. Alternative rehabilitation approaches are sorely needed for this population. Based on previous research with cancer and other medical populations a working draft of a treatment manual using a telephone-delivered Behavioral Activation and Problem Solving (BA/PS) intervention has been designed. Prior to testing the intervention in a randomized clinical trial, additional work must be completed. The specific aims of this study are to a. refine the BA/PS treatment manual, b. develop and apply treatment integrity measures for the BA/PS manual, c. assess participation restrictions and associated outcomes, d. preliminarily assess the immediate and maintenance effects of BA/PS, and e. examine mediators and moderators of BA/PS effects based on our "Self Regulation" model of functional recovery. 188 young-middle adult breast cancer survivors will be screened for participation restrictions following cancer treatment and 40 survivors with participation restrictions will receive BA/PS delivered by phone. BA/PS participants will be assessed for treatment effectiveness and interviewed regarding their experiences during treatment to provide information for refining the manual. The long-term objective of this line of research is to develop effective and feasible treatments for the medical and psychosocial consequences of cancer and its treatment in medically underse
Primary Outcome
* of patients evaluated for enrollment / # of patients approached. * of patients meeting eligibility criteria / # of patients evaluated. * of patients enrolled / # of patients meeting eligibility criteria * of patients completing 6 weeks of BA/PS treatment. * of patients completing each study assessment point (T1, T2, T3, T4).
Interventions
- BEHAVIORAL Behavioral activation/problem-solving (BA/PS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-04 |
| Phase | NA |
What the finished NCT01225328 record still lists
NCT01225328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Behavioral activation/problem-solving (BA/PS) is the first listed.
NCT01225328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01225328 about?
NCT01225328 is a clinical study titled "Participation Restrictions in Breast Cancer Survivors". This project will develop and preliminarily evaluate an intervention to assist young-middle adult rural breast cancer survivors to overcome functional impairments related to their cancer treatment. Younger breast cancer survivors (below age 60) have ongoing family, social and vocational responsibili...
What is the current status of trial NCT01225328?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2010-10. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01225328?
The interventions under investigation include: Behavioral activation/problem-solving (BA/PS) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01225328?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01225328's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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