Clinical trial NCT01779063: Promoting Adherence to Lymphedema Self-care
Official title: Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema Self-care
Keywords: lymphedema
self-care
breast cancer
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2013-01-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: symptom burden
timeFrame: change between baseline and 1, 3, 6, and 12 months post-intervention
measure: function
timeFrame: change between baseline and 1, 3, 6, and 12 months post-intervention
measure: psychological well-being
timeFrame: change between baseline and 1, 3, 6, and 12 months post-intervention
Secondary outcomes:
measure: coping
timeFrame: change between baseline and 1, 3, 6, and 12 months post-intervention
measure: self-care activities
timeFrame: Change between baseline 1, 3, 6, and 12 months post-intervention
measure: stress
timeFrame: change between baseline and 1, 3, 6, and 12 months post-intervention
measure: self-efficacy
timeFrame: change between baseline and 1, 3, 6, and 12 months post-intervention
measure: social support
timeFrame: change between baseline and 1, 3, 6, and 12 months post-intervention
measure: extracellular fluid
timeFrame: change between baseline and 3, 6, and 12 months post-intervention
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Univeristy School of Nursing
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: sheila h ridner, Phd
role: PRINCIPAL_INVESTIGATOR
References: