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Completed

NCT Number: NCT00027118

Morbidity After Diagnosis and Treatment of Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Fatigue Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Shoulder Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Naval Medical Center

Bethesda, Maryland, 20889, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Exclusion criteria

Subject chooses to not participate in the study.

Subjects are unable to complete the clinical examination tests.

Subjects are unable to complete the questionnaires/surveys.

Subjects are under age 18.

Treatment and study plan

Primary outcomes

  1. Upper limb strength

    Time frame: 1,3,6,9, 12, 18 24 months

  2. Upper limb range of motion

    Time frame: 1,3,6,9, 12, 18 24 months

  3. Upper limb volume

    Time frame: 1,3,6,9, 12, 18 24 months

  4. Arm disability questionnaire

    Time frame: 0, 12, 18, 24 months

  5. Quality of life questionnaire

    Time frame: 0, 12, 18, 24 months

  6. Physical activity questionnaire

    Time frame: 0, 12, 18, 24 months

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Registry information

Official study 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)

Important dates

Study start
2001
Study completion
2016
First posted
Nov 21, 2001
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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