Morbidity After Diagnosis and Treatment of Breast Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00027118|
Recruitment Status : Completed
First Posted : November 21, 2001
Last Update Posted : April 17, 2018
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|
|Breast Cancer Shoulder Lymphedema Fatigue|
|Study Type :||Observational|
|Actual Enrollment :||326 participants|
|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 :||November 16, 2001|
|Study Completion Date :||August 17, 2016|
- Upper limb strength [ Time Frame: 1,3,6,9, 12, 18 24 months ]
- Upper limb range of motion [ Time Frame: 1,3,6,9, 12, 18 24 months ]
- Upper limb volume [ Time Frame: 1,3,6,9, 12, 18 24 months ]
- Arm disability questionnaire [ Time Frame: 0, 12, 18, 24 months ]
- Quality of life questionnaire [ Time Frame: 0, 12, 18, 24 months ]
- Physical activity questionnaire [ Time Frame: 0, 12, 18, 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027118
|United States, Maryland|
|National Naval Medical Center|
|Bethesda, Maryland, United States, 20889|
|Principal Investigator:||Minal Jain, R.P.T.||National Institutes of Health Clinical Center (CC)|