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The Impact of Lymphedema on Breast Cancer Survivors

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00769821
First received: October 8, 2008
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  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 Survivor
Lymphedema
Perioperative/Postoperative Complications
 Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: bioimpedance spectroscopy
Procedure: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Lymphedema on Local and Overall Functioning

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

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) [ Time Frame: study visit approximately 5 hours ] [ 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 [ Time Frame: study visit approximately 5 hours ] [ Designated as safety issue: No ]
  • Local upper extremity function by tests & questionnaires (e.g., hand dominance; strength; range of motion & neurodynamics; fine motor control/finger coordination; skin exam; skin & scar sensation [Semmes-Weinstein Monofilament]) [ Time Frame: study visit approximately 5 hours ] [ 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 [ Time Frame: study visit approximately 5 hours ] [ Designated as safety issue: No ]
  • Quality of life (QOL) as assessed by Multidimensional QOL Scale [ Time Frame: study visit approximately 5 hours ] [ Designated as safety issue: No ]
  • Comorbidity as assessed by Charleston Comorbidity Scale [ Time Frame: study visit approximately 5 hours ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: February 2007
Study Completion Date: February 2009
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
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer survivors

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
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
Principal Investigator: Marylin J. Dodd, RN, PhD, FAAN University of California, San Francisco
  More Information

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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00769821     History of Changes
Obsolete Identifiers: NCT00501436
Other Study ID Numbers: CDR0000616135, USCF-H452-29674-03
Study First Received: October 8, 2008
Last Updated: December 11, 2012
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of California, San Francisco:
lymphedema
perioperative/postoperative complications
cancer survivor
stage I breast cancer
stage II breast cancer
 stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Postoperative Complications
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Lymphatic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013