NCT02073045

Brief Summary

This pilot clinical trial studies intensive education in increasing understanding of lymphedema in patients with breast cancer undergoing surgery. Lymphedema is the build-up of fluids in the arm (or other extremity) after surgery. Providing written educational handouts and verbal education on the risk factors and symptoms of lymphedema may improve patients' ability to identify symptoms of lymphedema after surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

2.1 years

First QC Date

February 25, 2014

Last Update Submit

October 22, 2015

Conditions

Breast CancerLymphedema

Outcome Measures

Primary Outcomes (2)

  • Improvement in participant's knowledge of lymphedema

    Quantitative data regarding number of correct answers to the survey questions pre-surgery and at the post-surgery 3 month re-test will be compared to assess if the lymphedema education improved the participant's knowledge of lymphedema.

    Baseline to 3 months post-surgery

  • Total girth differences as assessed by BUE circumferential measurements using the National Lymphedema Network (NLN) guidelines

    If a \> 2 cm difference is noted in girth from pre to post surgery measures, a referral will be forwarded to the physician by the study investigators and treatment options provided to the participant.

    Baseline to 3 months post-surgery

Study Arms (1)

Supportive care (lymphedema education)

EXPERIMENTAL

In an educational intervention, participants complete a five question lymphedema survey, designed by the Occupational Therapy staff, as an instrument to assess a patient's knowledge of lymphedema signs/symptoms before surgery. An OT, PT, and/or CLT provide written handouts to participants on the pathophysiology, signs, symptoms, and treatment of lymphedema. Participants repeat the survey at 3 months post-surgery. BUE circumferential measurements are also collected before surgery and at 3 months post-surgery.

Other: educational interventionOther: lymphedema survey

Interventions

educational interventionOTHER

Receive educational handouts

Also known as: intervention, educational
Supportive care (lymphedema education)
lymphedema surveyOTHER

Ancillary studies

Supportive care (lymphedema education)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be diagnosed with breast cancer; the participants will be scheduled for a lumpectomy or a mastectomy at UH GMC Seidman Cancer Center
  • They must understand written, verbal, and/or recorded survey questioning English

You may not qualify if:

  • Individuals with previous radiation treatments to the breast or axilla areas
  • Prior diagnosis of lymphedema
  • Persons that do not speak English
  • Those unwilling to participate in the follow-up call 3 months post-surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Interventions

Early Intervention, EducationalMethods

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative Techniques

Study Officials

  • Dotti Thompson

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 27, 2014

Study Start

August 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 23, 2015

Record last verified: 2015-10

Locations

US(1)