Ignite Creation Date:
2024-05-06 @ 1:17 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01779063
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2013-01-23
Brief Title:
Promoting Adherence to Lymphedema Self-care
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lymphedema is a chronic condition that causes physical and emotional challenges to breast cancer survivors As a progressive condition lymphedema can result in swellingfibrosis 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 socialhealthcare 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 formats 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 or an alternative format such as DVD Then over 12 months the investigators will periodically assess and compare both groups on self-care behaviors physical and emotional concerns and other issues such as money spent on lymphedema treatment The group that receives the education booklet will be given access to the Web-based intervention after the 12 month follow-up is done but the investigators will not ask them to complete any more forms
This project builds upon the investigators prior work that has provided information about lymphedema self-care problems and the investigators previous experience in developing patient education videos and manuals By providing accessible detailed self-care instructions and a psychosocial component this intervention has the potential to improve lymphedema self-care If successful this intervention can be offered to the larger national and international community of breast cancer survivors with lymphedema
This project builds upon the investigators prior work that has provided information about lymphedema self-care problems and the investigators previous experience in developing patient education videos and manuals By providing accessible detailed self-care instructions and a psychosocial component this intervention has the potential to improve lymphedema self-care If successful this intervention can be offered to the larger national and international community of breast cancer survivors with lymphedema
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None