Clinical trial NCT00769821: The Impact of Lymphedema on Breast Cancer Survivors
Official title: The Impact of Lymphedema on Local and Overall Functioning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Cancer Survivor
Lymphedema
Perioperative/Postoperative Complications
Keywords: 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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-10-09
Enrollment: 145
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer survivors

Brief summary: 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.

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 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

Primary outcomes:
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)
timeFrame: study visit approximately 5 hours
measure: 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
timeFrame: study visit approximately 5 hours
measure: 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])
timeFrame: study visit approximately 5 hours
measure: 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
timeFrame: study visit approximately 5 hours
measure: Quality of life (QOL) as assessed by Multidimensional QOL Scale
timeFrame: study visit approximately 5 hours
measure: Comorbidity as assessed by Charleston Comorbidity Scale
timeFrame: study visit approximately 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco School of Nursing
state: California
Study officials:
affiliation: University of California, San Francisco
name: Marylin J. Dodd, RN, PhD, FAAN
role: PRINCIPAL_INVESTIGATOR
References: