Breast CancerNCT00670644
Self-Care for Lymphedema in Patients With Breast Cancer
An observational study of Breast Cancer, run by Vanderbilt University at 3 sites in United States.
Trial summary
RATIONALE: Identifying why patients don't do self care for lymphedema may help doctors plan better at-home self-care treatment. PURPOSE: This research study is looking at self-care practices for lymphedema in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- questionnaire administration, survey administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2006to Mar 2011
- Phase
- Observational
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast Cancer patients
DISEASE CHARACTERISTICS:
- History of breast cancer
- Lymphedema in one or both arms that occurred during or after breast cancer treatment
- Must have received prior lymphedema treatment by a healthcare professional
- Patients with self-reported arm swelling subsequent to breast cancer treatment that has not been treated by a healthcare professional are not eligible
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- English speaking
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Breast Cancer Treatment Related Lymphedema Self Care Practices
RATIONALE: Identifying why patients don't do self care for lymphedema may help doctors plan better at-home self-care treatment.
PURPOSE: This research study is looking at self-care practices for lymphedema in patients with breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To systematically identify and describe the barriers to completing recommended at home self-care of lymphedema in patients with breast cancer.
- To identify patient recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others.
- To identify the current at home self-care practices of breast cancer survivors with treatment treated lymphedema.
Secondary
- To examine the relationship between at home self-care activities and symptoms in breast cancer survivors with lymphedema.
- To examine the relationship between at home self-care activities and quality of life in breast cancer survivors with lymphedema.
- To identify patient-perceived benefits to at home self-care.
OUTLINE: Patients complete questionnaires about their breast cancer diagnosis and treatment history, lymphedema history and problems, and years of education and income. Patients also complete surveys about home self-care practices for lymphedema and any benefits, burdens, or barriers of at home care.
- Conditions
- Breast Cancer
- Being tested
- questionnaire administration, survey administration, quality-of-life assessment
- Keywords
- male breast cancer, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Completed self-report form
survey administrationOther
Completed self-report form-other
quality-of-life assessmentProcedure or surgery
Completed self-report form qol
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and description of barriers to completing recommended at home self-care of lymphedema
Measured: one time only for approximately 15 minutes
Identification of patients recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others
Measured: one time only for approximately 15 minutes
Identification of current at home self-care practices for lymphedema
Measured: one time only for approximately 15 minutes
Secondary outcomes (2)
Relationship between at home self-care activities, symptoms, and quality of life in breast cancer survivors with lymphedema
Measured: one time only for approximately 15 minutes
Identification of patient-perceived benefits to at home self-care
Measured: one time only for approximately 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startMay 2006
- Primary completionMay 2007
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sheila Ridner, Vanderbilt University
- Investigators
- Shiela H. Ridner, MSN, PhD, RN, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670644
- Sponsor's protocol ID
- CDR0000587714
- Other IDs
- P30CA068485, VU-VICC-SUPP-0628, VU-VICC-060480
- Status last verified
- Apr 2017
- First submitted
- 1 May 2008
- 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
- Breast Cancer Treatment Related Lymphedema Self Care Practices
- ClinicalTrials.gov ID
- NCT00670644
- Acronym / sponsor ID
- CDR0000587714
- Conditions
- Breast Cancer
- Keywords
- male breast cancer, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 2 May 2008 (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.
RATIONALE: Identifying why patients don't do self care for lymphedema may help doctors plan better at-home self-care treatment.
PURPOSE: This research study is looking at self-care practices for lymphedema in patients with breast cancer.
Detailed description
OBJECTIVES:
Primary
- To systematically identify and describe the barriers to completing recommended at home self-care of lymphedema in patients with breast cancer.
- To identify patient recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others.
- To identify the current at home self-care practices of breast cancer survivors with treatment treated lymphedema.
Secondary
- To examine the relationship between at home self-care activities and symptoms in breast cancer survivors with lymphedema.
- To examine the relationship between at home self-care activities and quality of life in breast cancer survivors with lymphedema.
- To identify patient-perceived benefits to at home self-care.
OUTLINE: Patients complete questionnaires about their breast cancer diagnosis and treatment history, lymphedema history and problems, and years of education and income. Patients also complete surveys about home self-care practices for lymphedema and any benefits, burdens, or barriers of at home care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer patients
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 |
|---|---|---|
| questionnaire administrationCompleted self-report form | Other | – |
| survey administrationCompleted self-report form-other | Other | – |
| quality-of-life assessmentCompleted self-report form qol | Procedure or surgery | – |
Primary outcome
Identification and description of barriers to completing recommended at home self-care of lymphedema
Time frame: one time only for approximately 15 minutes
Identification of patients recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others
Time frame: one time only for approximately 15 minutes
Identification of current at home self-care practices for lymphedema
Time frame: one time only for approximately 15 minutes
2 secondary outcomes
Relationship between at home self-care activities, symptoms, and quality of life in breast cancer survivors with lymphedema
Time frame: one time only for approximately 15 minutes
Identification of patient-perceived benefits to at home self-care
Time frame: one time only for approximately 15 minutes
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.
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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.
Shiela H. Ridner, MSN, PhD, RN study chair
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Vanderbilt University at 3 sites 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?
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 3 sites 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?
Identification and description of barriers to completing recommended at home self-care of lymphedema (time frame: one time only for approximately 15 minutes). 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 7 Nov 2026.