Morbidity After Diagnosis and Treatment of Breast Cancer Patients

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT00027118

Collaborator

(none)

326

Enrollment

Location

177

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Shoulder Lymphedema Fatigue

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 Design

Study Type:

Observational

Actual Enrollment :

326 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective (Cohort) Study to Identify Factors Affecting Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer: A Multi-Institutional Study Between the National Institutes of Health (NIH) Rehabilitation Medicine Department (RMD) and the Walter Reed National Military Medical Center (WRNMMC) Breast Care Center (BCC)

Study Start Date :

Nov 16, 2001

Study Completion Date :

Aug 17, 2016

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:

Population/Subjects: Individuals with breast cancer are identified among the patient population at National Naval Medical Center (NNMC). Patients referred to the NNMC Breast Care Center) NNMC-BCC for diagnosis and management (surgical treatment and radiation treatment or chemotherapy) of histologically established breast cancer (stage I, II, III, or IV) during 2001-2003, are eligible to participate in the study.

Healthy female individuals will be controls.

Subjects must be over 18 years of age and post-puberty as breast cancer does not occur prior to puberty; and been seen pre-surgical or medical intervention for baseline measurements and agree to participate in six follow-up visits of 30-45 minutes in duration during the next two-years.