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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Lymphedema Self-care
- 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 group | Role | What they receive |
|---|---|---|
| web based multimedia intervention | Experimental | interactive,web based multimedia intervention Receives: Behavioral: web based multimedia intervention |
| education booklet | Active comparator | printed educational booklet Receives: Other: educational booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
function
Self-report functional data using a validated instrument
Measured: change between baseline and 1, 3, 6, and 12 months post-intervention
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)
coping
self-report using validated instrument
Measured: change between baseline and 1, 3, 6, and 12 months post-intervention
self-care activities
self report using a self-care checklist
Measured: Change between baseline 1, 3, 6, and 12 months post-intervention
stress
self-report using a validated instrument
Measured: change between baseline and 1, 3, 6, and 12 months post-intervention
self-efficacy
self-report using a validated instrument
Measured: change between baseline and 1, 3, 6, and 12 months post-intervention
social support
self-report using a validated instrument
Measured: change between baseline and 1, 3, 6, and 12 months post-intervention
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.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema Self-careStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Sheila Ridner, Vanderbilt University
- Investigators
- sheila h ridner, Phd, Principal investigator, Vanderbilt University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01779063
- Acronym / sponsor ID
- 124137-RSG-13-022-01-CPPB
- Conditions
- Lymphedema Self-care
- Keywords
- lymphedema, self-care, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Jan 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| web based multimedia intervention | Experimental | Behavioral: web based multimedia interventioninteractive,web based multimedia intervention |
| education booklet | Active comparator | Other: educational bookletprinted educational booklet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- undergoing chemotherapy or radiation, or
- receiving hospice care. Additional exclusion criteria for local participants undergoing bioelectrical impedance measurements: pregnancy, metal implants, and defibrillator implants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web based multimedia interventioncognitive therapy based web intervention | Behavioural | web based multimedia intervention |
| educational bookletpatient education booklet | Other | education booklet |
Primary outcome
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
function
Time frame: change between baseline and 1, 3, 6, and 12 months post-intervention
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
self-report using a validated instrument
6 secondary outcomes
coping
Time frame: change between baseline and 1, 3, 6, and 12 months post-intervention
self-care activities
Time frame: Change between baseline 1, 3, 6, and 12 months post-intervention
stress
Time frame: change between baseline and 1, 3, 6, and 12 months post-intervention
self-efficacy
Time frame: change between baseline and 1, 3, 6, and 12 months post-intervention
social support
Time frame: change between baseline and 1, 3, 6, and 12 months post-intervention
extracellular fluid
Time frame: change between baseline and 3, 6, and 12 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
Related trials for Lymphedema Self-care
Enrolling by invitation
Effectiveness of Self-Physiotherapy in the Management of Lymphedema
Breast Cancer, Lymphedema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sheila h ridner, Phd principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
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.