The Impact of Lymphedema on Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

The Impact of Lymphedema on Local and Overall Functioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769821
• Other study ID #: CDR0000616135
• Secondary ID: USCF-H452-29674-
• Status: Completed
• Phase: N/A
• First received: October 8, 2008
• Last updated: December 11, 2012
• Start date: February 2007
• Est. completion date: February 2009

Study information

• Verified date: December 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00501436

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• questionnaire administration

Procedure:
• assessment of therapy complications

• bioimpedance spectroscopy

• quality-of-life assessment

Locations

Country	Name	City	State
United States	University of California, San Francisco School of Nursing	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of lymphedema as assessed by the Norman Questionnaire, Jane M. Armer's Lymphedema and Breast Cancer Questionnaire, arm circumference, and bioimpedance spectroscopy (BIS)		study visit approximately 5 hours	No
Primary	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		study visit approximately 5 hours	No
Primary	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])		study visit approximately 5 hours	No
Primary	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		study visit approximately 5 hours	No
Primary	Quality of life (QOL) as assessed by Multidimensional QOL Scale		study visit approximately 5 hours	No
Primary	Comorbidity as assessed by Charleston Comorbidity Scale		study visit approximately 5 hours	No