NCT00670644

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

May 1, 2008

Last Update Submit

April 7, 2017

Conditions

Keywords

male breast cancerrecurrent breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (3)

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

    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

    one time only for approximately 15 minutes

  • Identification of current at home self-care practices for lymphedema

    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

    one time only for approximately 15 minutes

  • Identification of patient-perceived benefits to at home self-care

    one time only for approximately 15 minutes

Interventions

Completed self-report form

Completed self-report form-other

Completed self-report form qol

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Shiela H. Ridner, MSN, PhD, RN

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 2, 2008

Study Start

May 1, 2006

Primary Completion

May 1, 2007

Study Completion

March 1, 2011

Last Updated

April 10, 2017

Record last verified: 2017-04

Locations