The Impact of Lymphedema on Breast Cancer Survivors - Full Text View

Sponsors and Collaborators:	UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00769821

Purpose

RATIONALE: Gathering information from breast cancer survivors about lymphedema; its symptoms and their impact on shoulder, arm, and hand functioning; and quality of life may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying the impact of lymphedema on breast cancer survivors.

Condition	Intervention
Breast Cancer Cancer-Related Problem/Condition	Procedure: assessment of therapy complications Procedure: bioimpedance spectroscopy Procedure: quality-of-life assessment Procedure: questionnaire administration

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Breast Cancer Cancer Lymphedema

U.S. FDA Resources

Study Type:	Observational
Official Title:	The Impact of Lymphedema on Local and Overall Functioning

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Degree of lymphedema as assessed by the Norman Questionnaire, Jane M. Armer's Lymphedema and Breast Cancer Questionnaire, arm circumference, and bioimpedance spectroscopy (BIS) [ Designated as safety issue: No ]
Lymphedema-associated symptoms by Symptoms in the Affected Breast/Mastectomy site questionnaire; Symptoms in the Shoulder, Arm, or Hand on the Affected Side questionnaire; and General Symptom Experience questionnaire [ Designated as safety issue: No ]
Local upper extremity funct by tests & questionnaires (e.g., hand dominance; strength; range of motion & neurodynamics; fine motor ctrl/finger coord; skin exam; skin & scar sensation [Semmes-Weinstein Monofilament]) [ Designated as safety issue: No ]
Overall health-related functioning as assessed by Medical Outcomes Study-Short Form 36 (MOS-SF36), graded exercise test using a treadmill stress test, and cardio-respiratory fitness using peak VO2 [ Designated as safety issue: No ]
Quality of life (QOL) as assessed by Multidimensional QOL Scale [ Designated as safety issue: No ]
Comorbidity as assessed by Charleston Comorbidity Scale [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	February 2007
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To determine the relationship between degree of lymphedema, lymphedema-associated symptoms, and local upper extremity functioning.
To determine the relationship between degree of lymphedema, lymphedema-associated symptoms, local upper extremity functioning, and overall health-related functioning.
To determine the relationship between degree of lymphedema, lymphedema-associated symptoms, local upper extremity functioning, overall health-related functioning, and quality of life.

OUTLINE: Patients are stratified according to presence of lymphedema (yes vs no).

Patients complete self-reporting questionnaires to assess the degree of lymphedema using the Norman Questionnaire and Jane M. Armer's Lymphedema and Breast Cancer Questionnaire; lymphedema-associated symptoms using Symptoms in the Affected Breast/Mastectomy site questionnaire, Symptoms in the Shoulder, Arm, or Hand on the Affected Side questionnaire, and General Symptom Experience questionnaire; local upper extremity functioning using hand dominance questionnaire and the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire; quality of life (QOL) using the Multidimensional QOL Scale; and comorbidity using the Charleston Comorbidity Scale. Patients undergo a 3.5-hour testing to assess the degree of lymphedema by arm circumference and bioimpedance spectroscopy (BIS); local upper extremity functioning by strength testing, range of movement and neurodynamic testing using a goniometer, a skin examination, skin sensation and sensation at scar using the Semmes-Weinstein Monofilament test, and fine motor control/finger coordination using the Purdue Pegboard, Finger Tapper, and Vibration Threshold; and overall health-related functioning using a graded exercise test.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer
- No breast cancer on both sides
- No recurrence of breast cancer (local or distant)
Completed active treatment for breast cancer (i.e., surgery and/or radiotherapy and/or chemotherapy) for ≥ 6 months
- No prior contralateral or bilateral mastectomy
No pre-existing lymphedema prior to breast cancer diagnosis
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
Weight < 300 pounds
Mentally and physically able to participate
No current infection or lymphangitis involving the affected arm
No pre-existing neuromuscular conditions that would affect local upper extremity or overall health-related functioning
No contraindications to bioimpedance spectroscopy (BIS) testing, including the application of electrode adhesive pads to the skin (i.e., unable to lie supine, allergy to electrode adhesive pads, have sunburn, or have open wound)
No contraindications to exercise testing as outlined by the American Heart Association and the American College of Sports Medicine

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769821

Locations

United States, California
University of California, San Francisco School of Nursing	Recruiting
San Francisco, California, United States, 94115
Contact: Marylin J. Dodd, RN, PhD, FAAN 415-476-4320

Sponsors and Collaborators

UCSF Helen Diller Family Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Marylin J. Dodd, RN, PhD, FAAN

University of California, San Francisco

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	University of California, San Francisco School of Nursing ( Regulatory Protocol Associate )
Study ID Numbers:	CDR0000616135, USCF-H452-29674-03
Study First Received:	October 8, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00769821
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

lymphedema
perioperative/postoperative complications
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
lymphedema

Study placed in the following topic categories:

Lymphedema
Lymphatic Diseases
Skin Diseases

Postoperative Complications
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009