Morbidity After Diagnosis and Treatment of Breast Cancer Patients

Completed

• Conditions: Breast Cancer; Shoulder; Fatigue; Lymphedema

• Registration Number: NCT00027118
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

This study will examine the frequency and severity of problems in women with breast cancer for 2 years following initial medical treatment, including:

* Physical impairments, such as loss of strength or flexibility, increased weight and swelling.

* Symptom distress, such as pain, fatigue and weakness.

* Functional limitations and disabilities, such as loss of independence in activities of daily living (e.g., grooming, bathing, dressing, driving a car), work and social and recreational activities.

It will identify factors associated with these problems and try to determine their relationship to them.

Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible for this study. Women who have a breast biopsy negative for cancer will also be enrolled as control subjects. Participants will be drawn from patients referred to the National Naval Medical Center for diagnosis and treatment during 2001-2003.

Participants will be evaluated over a 2-year period during an initial baseline visit (before medical treatment or biopsy) and follow-up visits at 1, 3, 6, 12, 18 and 24 months following procedures:

* Interview about past medical history and present illness, social and recreational activities, functional independence at work and during activities of daily living.

* Completion of questionnaires including health survey, upper limb disability questionnaire, and physical activity questionnaire. (Questionnaires are completed only at baseline and 12 and 24 months after medical treatment begins.) The questionnaires take about 30 to 40 minutes to complete.

* Upper body examination, including pain measurement using a 10-point scale, active and passive range of motion measures, manual muscle testing measures using a 10-point scale, timed upper limb lift test, and measures of upper limb volume and girth.

Detailed Description

Patients and healthy participants will undergo an interview at the beginning of the study and 1,3,6,9, 12, 18 and 24 months and answer questions about their medical history; family history; current problem and treatment; pain history; and social, physical and recreational activities. At the visit, they will also undergo an upper body physical exam by a physical therapist. Patients and the healthy participants will also fill out questionnaires about arm disability, quality of life, and physical activity at the beginning of the study and at 12, 18, and 24 months.

Study Timeline

• Study Start: 2001-11-16
• Study First Submitted: 2001-11-20
• Study First Submitted QC: 2001-11-20
• Study First Posted: 2001-11-21
• Status Verified: 2016-08-17
• Study Completion: 2016-08-17
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life questionnaire	0, 12, 18, 24 months
Upper limb strength	1,3,6,9, 12, 18 24 months
Upper limb volume	1,3,6,9, 12, 18 24 months
Upper limb range of motion	1,3,6,9, 12, 18 24 months
Arm disability questionnaire	0, 12, 18, 24 months
Physical activity questionnaire	0, 12, 18, 24 months

Trial Locations

Locations (1)

National Naval Medical Center; 🇺🇸 Bethesda, Maryland, United States