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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: Completed NA study, sponsored by Vanderbilt University.

NCT01779063 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 160 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

self-report of symptoms will be documented on study instruments

Interventions

  • BEHAVIORAL web based multimedia intervention
  • OTHER educational booklet

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2013-01
Est. Completion 2016-12
Phase NA
Vanderbilt University

430 total trials

What the finished NCT01779063 record still lists

NCT01779063 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which web based multimedia intervention is the first listed.

NCT01779063 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01779063's enrollment target sits among peer trials

160 628th of 2000 higher than 1,347 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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Source: ClinicalTrials.gov NCT01779063, the US trial registry maintained by the National Library of Medicine. NCT01779063 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.