Promoting Adherence to Lymphedema Self-care

Not Applicable

Completed

• Conditions: Lymphedema Self-care
• Interventions: Behavioral: web based multimedia intervention; Other: educational booklet

• Registration Number: NCT01779063
• Lead Sponsor: Vanderbilt University

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 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 (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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-30
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. have a history of breast cancer;
2. previous diagnosis of lymphedema;
3. Stage II lymphedema based upon International Society of Lymphedema (the limb is firm in places, elevation does not reduce swelling, it may or may not pit with pressure, and skin changes may be noted);
4. be age 18 or older;
5. be able to see and read printed documents in English; and for stage 2 only,
6. have access to the Internet or a smart phone.

Exclusion Criteria

will not be:

1. undergoing chemotherapy or radiation, or
2. receiving hospice care. Additional exclusion criteria for local participants undergoing bioelectrical impedance measurements: pregnancy, metal implants, and defibrillator implants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
web based multimedia intervention	web based multimedia intervention	interactive,web based multimedia intervention
education booklet	educational booklet	printed educational booklet

Primary Outcome Measures

Name	Time	Method
symptom burden	change between baseline and 1, 3, 6, and 12 months post-intervention	self-report of symptoms will be documented on study instruments
psychological well-being	change between baseline and 1, 3, 6, and 12 months post-intervention	self-report using a validated instrument
function	change between baseline and 1, 3, 6, and 12 months post-intervention	Self-report functional data using a validated instrument

Secondary Outcome Measures

Name	Time	Method
extracellular fluid	change between baseline and 3, 6, and 12 months post-intervention	bioelectrical impedence measurement for sub set of participants
self-efficacy	change between baseline and 1, 3, 6, and 12 months post-intervention	self-report using a validated instrument
stress	change between baseline and 1, 3, 6, and 12 months post-intervention	self-report using a validated instrument
self-care activities	Change between baseline 1, 3, 6, and 12 months post-intervention	self report using a self-care checklist
coping	change between baseline and 1, 3, 6, and 12 months post-intervention	self-report using validated instrument
social support	change between baseline and 1, 3, 6, and 12 months post-intervention	self-report using a validated instrument

Trial Locations

Locations (1)

Vanderbilt Univeristy School of Nursing; 🇺🇸 Nashville, Tennessee, United States