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Lymphedema Self-careNCT01779063

Promoting Adherence to Lymphedema Self-care

A study testing web based multimedia intervention and educational booklet in people with Lymphedema Self-care, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphedema Self-care
What is being tested?
web based multimedia intervention and educational booklet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
Jan 2013to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt Univeristy School of Nursing

    Nashville, Tennessee, 37072

Other trials in United States

About this study

Official title: Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors

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.

Being tested
web based multimedia intervention, educational booklet
Keywords
lymphedema, self-care, breast cancer
Medical subject headings
Lymphedema, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • web based multimedia interventionBehavioural

    cognitive therapy based web intervention

  • educational bookletOther

    patient education booklet

Study groups in NCT01779063
Study groupRoleWhat they receive
web based multimedia interventionExperimentalinteractive,web based multimedia intervention
Receives: Behavioral: web based multimedia intervention
education bookletActive comparatorprinted educational booklet
Receives: Other: educational booklet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. symptom burden

    self-report of symptoms will be documented on study instruments

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

  2. function

    Self-report functional data using a validated instrument

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

  3. psychological well-being

    self-report using a validated instrument

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

Secondary outcomes (6)
  1. coping

    self-report using validated instrument

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

  2. self-care activities

    self report using a self-care checklist

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

  3. stress

    self-report using a validated instrument

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

  4. self-efficacy

    self-report using a validated instrument

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

  5. social support

    self-report using a validated instrument

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

  6. extracellular fluid

    bioelectrical impedence measurement for sub set of participants

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01779063
Sponsor's protocol ID
124137-RSG-13-022-01-CPPB
Status last verified
Apr 2017
First submitted
23 Jan 2013
Last updated
10 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing web based multimedia intervention and educational booklet in people with Lymphedema Self-care, run by Vanderbilt University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

symptom burden (time frame: change between baseline and 1, 3, 6, and 12 months post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017; AzTrials last refreshed its copy on 30 Oct 2026.

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