Lymphedema Self-care Clinical Trial
Official title:
Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors
| Verified date | April 2017 |
| Source | Vanderbilt University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Vanderbilt Univeristy School of Nursing | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Vanderbilt University | American Cancer Society, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | symptom burden | self-report of symptoms will be documented on study instruments | change between baseline and 1, 3, 6, and 12 months post-intervention | |
| Primary | function | Self-report functional data using a validated instrument | change between baseline and 1, 3, 6, and 12 months post-intervention | |
| Primary | psychological well-being | self-report using a validated instrument | change between baseline and 1, 3, 6, and 12 months post-intervention | |
| Secondary | coping | self-report using validated instrument | change between baseline and 1, 3, 6, and 12 months post-intervention | |
| Secondary | self-care activities | self report using a self-care checklist | Change between baseline 1, 3, 6, and 12 months post-intervention | |
| Secondary | stress | self-report using a validated instrument | change between baseline and 1, 3, 6, and 12 months post-intervention | |
| Secondary | self-efficacy | self-report using a validated instrument | change between baseline and 1, 3, 6, and 12 months post-intervention | |
| Secondary | social support | self-report using a validated instrument | change between baseline and 1, 3, 6, and 12 months post-intervention | |
| Secondary | extracellular fluid | bioelectrical impedence measurement for sub set of participants | change between baseline and 3, 6, and 12 months post-intervention |