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Completed

NCT Number: NCT01779063

Promoting Adherence to Lymphedema Self-care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt Univeristy School of Nursing

Nashville, Tennessee, 37072, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

will not be:

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

Treatment and study plan

web based multimedia intervention

Behavioral

cognitive therapy based web intervention

educational booklet

Other

patient education booklet

Primary outcomes

  1. symptom burden

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

    self-report of symptoms will be documented on study instruments

  2. function

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

    Self-report functional data using a validated instrument

  3. psychological well-being

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

    self-report using a validated instrument

Secondary outcomes

  1. coping

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

    self-report using validated instrument

  2. self-care activities

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

    self report using a self-care checklist

  3. stress

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

    self-report using a validated instrument

  4. self-efficacy

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

    self-report using a validated instrument

  5. social support

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

    self-report using a validated instrument

  6. extracellular fluid

    Time frame: change between baseline and 3, 6, and 12 months post-intervention

    bioelectrical impedence measurement for sub set of participants

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2013
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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