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CompletedNCT00670644Updated Apr 10, 2017

Self-Care for Lymphedema in Patients With Breast Cancer

An observational study in Breast Cancer, sponsored by Vanderbilt University. Completed at 3 sites in United States. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-04-10.

Sponsored by Vanderbilt University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
51
Ages
18 Years to 120 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 51 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Breast Cancer patients

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
51 participants (actual)

Interventions

  • Otherquestionnaire administration

    Completed self-report form

  • Othersurvey administration

    Completed self-report form-other

  • Procedurequality-of-life assessment

    Completed self-report form qol

06

What researchers measure

Primary outcomes

  1. Identification and description of barriers to completing recommended at home self-care of lymphedema

    Time frame: one time only for approximately 15 minutes

  2. 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

  3. Identification of current at home self-care practices for lymphedema

    Time frame: one time only for approximately 15 minutes

Secondary outcomes

  1. 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

  2. Identification of patient-perceived benefits to at home self-care

    Time frame: one time only for approximately 15 minutes

07

Study locations

3 sites
  • Vanderbilt-Ingram Cancer Center - Cool Springs
    Nashville, Tennessee 37064, United States
  • Vanderbilt-Ingram Cancer Center at Franklin
    Nashville, Tennessee 37064, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00670644
Lead sponsor
Vanderbilt University
Collaborators
National Cancer Institute (NCI)
Responsible party
Sheila Ridner (Professor, Vanderbilt University) — Principal investigator
First posted
May 2, 2008
Start date
May 2006
Primary completion
May 2007
Completion
Mar 2011
Last update
Apr 10, 2017

Study contacts

Shiela H. Ridner, MSN, PhD, RN
study chair · Vanderbilt-Ingram Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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