Promoting Adherence to Lymphedema Self-care

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Sheila H. Ridner, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01779063
First received: January 23, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Lymphedema Self-care
Behavioral: web based multimedia intervention
Other: educational booklet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • symptom burden [ Time Frame: change between baseline and 1, 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
    self-report of symptoms will be documented on study instruments

  • function [ Time Frame: change between baseline and 1, 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
    Self-report functional data using a validated instrument

  • psychological well-being [ Time Frame: change between baseline and 1, 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
    self-report using a validated instrument


Secondary Outcome Measures:
  • coping [ Time Frame: change between baseline and 1, 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
    self-report using validated instrument

  • self-care activities [ Time Frame: Change between baseline 1, 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
    self report using a self-care checklist

  • stress [ Time Frame: change between baseline and 1, 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
    self-report using a validated instrument

  • self-efficacy [ Time Frame: change between baseline and 1, 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
    self-report using a validated instrument

  • social support [ Time Frame: change between baseline and 1, 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
    self-report using a validated instrument

  • extracellular fluid [ Time Frame: change between baseline and 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
    bioelectrical impedence measurement for sub set of participants


Estimated Enrollment: 110
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: web based multimedia intervention
interactive,web based multimedia intervention
Behavioral: web based multimedia intervention
Active Comparator: education booklet
printed educational booklet
Other: educational booklet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779063

Locations
United States, Tennessee
Vanderbilt Univeristy School of Nursing
Nashville, Tennessee, United States, 37072
Sponsors and Collaborators
Vanderbilt University
American Cancer Society, Inc.
Investigators
Principal Investigator: sheila h ridner, Phd Vanderbilt University
  More Information

No publications provided

Responsible Party: Sheila H. Ridner, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01779063     History of Changes
Other Study ID Numbers: 124137-RSG-13-022-01-CPPB
Study First Received: January 23, 2013
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
lymphedema
self-care
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014