Promoting Adherence to Lymphedema Self-care

NCT01779063 | Completed

• 1 other identifier: 124137-RSG-13-022-01-CPPB
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema Self-care

Keywords

lymphedema; self-care; breast cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• coping

  change between baseline and 1, 3, 6, and 12 months post-intervention

• self-care activities

  Change between baseline 1, 3, 6, and 12 months post-intervention

• stress

  change between baseline and 1, 3, 6, and 12 months post-intervention

• self-efficacy

  change between baseline and 1, 3, 6, and 12 months post-intervention

• social support

  change between baseline and 1, 3, 6, and 12 months post-intervention

Study Arms (2)

web based multimedia intervention

EXPERIMENTAL

interactive,web based multimedia intervention

Behavioral: web based multimedia intervention

education booklet

ACTIVE COMPARATOR

printed educational booklet

Other: educational booklet

Interventions

web based multimedia intervention BEHAVIORAL

cognitive therapy based web intervention

web based multimedia intervention

educational booklet OTHER

patient education booklet

education booklet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a history of breast cancer;
• previous diagnosis of lymphedema;
• 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);
• be age 18 or older;
• be able to see and read printed documents in English; and for stage 2 only,
• have access to the Internet or a smart phone.

You may not qualify if:

• undergoing chemotherapy or radiation, or

Sponsors & Collaborators

• Vanderbilt University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Vanderbilt Univeristy School of Nursing

Nashville, Tennessee, 37072, United States

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• sheila h ridner, Phd

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)