Self-Care for Lymphedema in Patients With Breast Cancer

Sponsor
Vanderbilt University (Other)
Overall Status
Completed
CT.gov ID
NCT00670644
Collaborator
National Cancer Institute (NCI) (NIH)
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire administration
  • Other: survey administration
  • Procedure: quality-of-life assessment

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

Study Type:
Observational
Actual Enrollment :
51 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Breast Cancer Treatment Related Lymphedema Self Care Practices
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
Mar 1, 2011

Outcome Measures

Primary Outcome Measures

  1. Identification and description of barriers to completing recommended at home self-care of lymphedema [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 [one time only for approximately 15 minutes]

  3. Identification of current at home self-care practices for lymphedema [one time only for approximately 15 minutes]

Secondary Outcome Measures

  1. Relationship between at home self-care activities, symptoms, and quality of life in breast cancer survivors with lymphedema [one time only for approximately 15 minutes]

  2. Identification of patient-perceived benefits to at home self-care [one time only for approximately 15 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt-Ingram Cancer Center - Cool Springs Nashville Tennessee United States 37064
2 Vanderbilt-Ingram Cancer Center at Franklin Nashville Tennessee United States 37064
3 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838

Sponsors and Collaborators

  • Vanderbilt University
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Shiela H. Ridner, MSN, PhD, RN, Vanderbilt-Ingram Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheila Ridner, Professor, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00670644
Other Study ID Numbers:
  • CDR0000587714
  • P30CA068485
  • VU-VICC-SUPP-0628
  • VU-VICC-060480
First Posted:
May 2, 2008
Last Update Posted:
Apr 10, 2017
Last Verified:
Apr 1, 2017

Study Results

No Results Posted as of Apr 10, 2017