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The Impact of Lymphedema on Local and Overall Functioning


N/A
21 Years
N/A
Not Enrolling
Female
Breast Cancer, Cancer Survivor, Lymphedema, Perioperative/Postoperative Complications

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Trial Information

The Impact of Lymphedema on Local and Overall Functioning


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Degree of lymphedema as assessed by the Norman Questionnaire, Jane M. Armer's Lymphedema and Breast Cancer Questionnaire, arm circumference, and bioimpedance spectroscopy (BIS)

Outcome Time Frame:

study visit approximately 5 hours

Safety Issue:

No

Principal Investigator

Marylin J. Dodd, RN, PhD, FAAN

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Data and Safety Monitoring Board

Study ID:

CDR0000616135

NCT ID:

NCT00769821

Start Date:

February 2007

Completion Date:

February 2009

Related Keywords:

  • Breast Cancer
  • Cancer Survivor
  • Lymphedema
  • Perioperative/Postoperative Complications
  • 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
  • Breast Neoplasms
  • Lymphedema
  • Postoperative Complications

Name

Location

University of California, San Francisco School of NursingSan Francisco, California  94115