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Morbidity After Diagnosis and Treatment of Breast Cancer Patients

NCT00027118 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 326

Last updated 2019-12-16

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Minal Jain, R.P.T. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-11-16
Completion
2016-08-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00027118 on ClinicalTrials.gov