The Impact of Lymphedema on Breast Cancer Survivors

NCT00769821 | Completed

• 2 other identifiers: CDR0000616135USCF-H452-29674-03
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• Quality of life (QOL) as assessed by Multidimensional QOL Scale

  study visit approximately 5 hours

• Comorbidity as assessed by Charleston Comorbidity Scale

  study visit approximately 5 hours

Interventions

questionnaire administration OTHER

assessment of therapy complications PROCEDURE

bioimpedance spectroscopy PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer survivors

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco School of Nursing

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema; Postoperative Complications

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marylin J. Dodd, RN, PhD, FAAN

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: February 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

US (1)