Questionnaire administration and survey administration and quality-of-life assessment in Breast Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Breast Cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Identification and description of barriers to completing recommended at home self-care of lymphedema Time Frame: one time only for approximately 15 minutes	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	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	one time only for approximately 15 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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	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	one time only for approximately 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 1, 2008

First Submitted That Met QC Criteria