- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00027118
Morbidity After Diagnosis and Treatment of Breast Cancer Patients
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)
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20889
- National Naval Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Upper limb strength
Time Frame: 1,3,6,9, 12, 18 24 months
|
1,3,6,9, 12, 18 24 months
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Upper limb range of motion
Time Frame: 1,3,6,9, 12, 18 24 months
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1,3,6,9, 12, 18 24 months
|
Upper limb volume
Time Frame: 1,3,6,9, 12, 18 24 months
|
1,3,6,9, 12, 18 24 months
|
Arm disability questionnaire
Time Frame: 0, 12, 18, 24 months
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0, 12, 18, 24 months
|
Quality of life questionnaire
Time Frame: 0, 12, 18, 24 months
|
0, 12, 18, 24 months
|
Physical activity questionnaire
Time Frame: 0, 12, 18, 24 months
|
0, 12, 18, 24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Minal Jain, R.P.T., National Institutes of Health Clinical Center (CC)
Publications and helpful links
General Publications
- King KB, Nail LM, Kreamer K, Strohl RA, Johnson JE. Patients' descriptions of the experience of receiving radiation therapy. Oncol Nurs Forum. 1985 Jul-Aug;12(4):55-61. No abstract available.
- Meyerowitz BE, Watkins IK, Sparks FC. Quality of life for breast cancer patients receiving adjuvant chemotherapy. Am J Nurs. 1983 Feb;83(2):232-5. No abstract available.
- Carter BJ. Women's experiences of lymphedema. Oncol Nurs Forum. 1997 Jun;24(5):875-82.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 020045
- 02-CC-0045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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