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Morbidity After Diagnosis and Treatment of Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00027118
First received: November 20, 2001
Last updated: August 18, 2016
Last verified: August 2016

November 20, 2001
August 18, 2016
November 2001
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  • Upper limb strength [ Time Frame: 1,3,6,9, 12, 18 24 months ] [ Designated as safety issue: No ]
  • Upper limb range of motion [ Time Frame: 1,3,6,9, 12, 18 24 months ] [ Designated as safety issue: No ]
  • Upper limb volume [ Time Frame: 1,3,6,9, 12, 18 24 months ] [ Designated as safety issue: No ]
  • Arm disability questionnaire [ Time Frame: 0, 12, 18, 24 months ] [ Designated as safety issue: No ]
  • Quality of life questionnaire [ Time Frame: 0, 12, 18, 24 months ] [ Designated as safety issue: No ]
  • Physical activity questionnaire [ Time Frame: 0, 12, 18, 24 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00027118 on ClinicalTrials.gov Archive Site
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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.
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.
Observational
Time Perspective: Prospective
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  • Breast Cancer
  • Shoulder
  • Lymphedema
  • Fatigue
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
August 2016
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  • 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.

Both
18 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00027118
020045, 02-CC-0045
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National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
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Principal Investigator: Minal Jain, R.P.T. National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP