Promoting Adherence to Lymphedema Self-care

Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema Self-care
• Intervention / Treatment: Behavioral: web based multimedia intervention; Other: educational booklet

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37072
      • Vanderbilt Univeristy School Of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: web based multimedia intervention; interactive,web based multimedia intervention	Behavioral: web based multimedia intervention; cognitive therapy based web intervention
Active Comparator: education booklet; printed educational booklet	Other: educational booklet; patient education booklet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: American Cancer Society, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 25, 2013
• First Posted (Estimate): January 30, 2013

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: breast cancer; lymphedema; self-care
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 124137-RSG-13-022-01-CPPB