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NCT01779063 · ClinicalTrials.gov registry record · NA
Promoting Adherence to Lymphedema Self-care
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 160
- Enrollment target
NCT01779063 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 160 participants.
The verdict
NCT01779063, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
Study Summary
Lymphedema is a chronic condition that causes physical and emotional challenges to breast cancer survivors. As a progressive condition, lymphedema can result in swelling/fibrosis that can impair function, promote infection, and cause discomfort and emotional distress. Daily self-care that is required to manage lymphedema is time-consuming, burdensome, and lifelong. Previous studies found that about half of breast cancer survivors with lymphedema do not complete self-care as directed. Feelings of being helpless to manage the condition, a desire to be normal, lack of noticeable results from self-care, and poor social/healthcare professional support are barriers to performing self-care on a regular basis. There is a need to develop and test interventions to promote effective self-care. Experts suggest the best self-care interventions should include patient perspectives and be available a readily accessible format. Technological advancements support use of innovative, creative approaches, such as Web-based multimedia interventions. Web-based interventions can be used in rural and urban settings. The investigators are proposing to develop a Web-based, multimedia intervention and a "take home" manual to support self-care in breast cancer survivors with lymphedema. The investigators plan to conduct focus groups with these survivors to determine the content and delivery format(s) and to help us identify breast cancer survivors with lymphedema for the video component. The investigators will then develop an intervention that will include self-care demonstrations and other supportive information to help patients to cope with the challenges of self-care. The focus groups will reconvene, review the intervention, and give us feedback on modifying and refining the intervention. After finalizing the intervention, The investigators will recruit more breast cancer survivors with lymphedema and provide one half of them an education booklet and the other half the Web-based intervention
Interventions
- BEHAVIORAL web based multimedia intervention
- OTHER educational booklet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01779063
The ClinicalTrials.gov registry entry for NCT01779063 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which web based multimedia intervention is the first listed.
NCT01779063 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01779063 about?
NCT01779063 is a clinical study titled "Promoting Adherence to Lymphedema Self-care". Lymphedema is a chronic condition that causes physical and emotional challenges to breast cancer survivors. As a progressive condition, lymphedema can result in swelling/fibrosis that can impair function, promote infection, and cause discomfort and emotional distress. Daily self-care that is require...
What is the current status of trial NCT01779063?
This trial is currently completed. It is a NA study. The enrollment target is 160 participants. The study started on 2013-01. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01779063?
The interventions under investigation include: web based multimedia intervention (BEHAVIORAL), educational booklet (OTHER).
Who is sponsoring clinical trial NCT01779063?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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