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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

18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

This retrospective (case-control) outcome study will investigate the frequency and severity
of morbidities in a population of approximately 160 patients diagnosed with breast cancer
before and after medical and surgical treatment. Subjects will be followed for one-year
with quarterly examinations (baseline [pre-medical treatment] and at 1, 3 months, 6 months,
9 months and 12 months after treatment). In order for cancer survivors to understand the
risk of impairment and functional limitations, and disability; and for health care providers
to determine the risk of physical impairment, functional limitations, and loss of
independence (morbidity) in patients with breast cancer; it is necessary to study these
patients from the point of diagnosis (before surgery) to a reasonable period following the
completion of the primary treatment program (1 year after medical treatment). Although
pain, numbness, fatigue, lymphedema and diminished physical function are described as
prevalent and debilitating conditions, remarkably few clinical studies are published
describing the associated physical impairments, functional limitations or on methods for
their control with measures prior to medical intervention and long-term follow-up. While
several past reports have identified the impact of medical and surgical intervention on
symptom distress and functional capacity of these patients, these studies do not provide
sufficient evidence to identify the: 1) level of physical impairment that predicts morbidity
in these patients, 2) individual factors that are specific predictors of morbidity in these
patients, or 3) time period in which these morbidities occur. The majority of previous
studies investigating morbidity of patients with breast cancer following medical and
surgical intervention are cross-sectional, case series, retrospective analysis without a
comparison/control group and without baseline measures prior to intervention. The proposed
outcome study will include: 1) a retrospective review of specific medical record
information such as staging conference information and the standard clinical quarterly
examination during a one year period, and 2) administration of a follow-up outcome
questionnaire, a physical activity questionnaire and a quality of life questionnaire at the
6 and 12 months time points. The outcome survey is an upper limb disability questionnaire
developed as an outcome measure for this project. Data available in these measurement
domains will allow the researchers to determine the: 1) frequency and severity of: a)
symptom distress (fatigue, pain including chronic pain, aching, weakness, burning, tingling,
numbness, anxiety, and depression) and pathological conditions (adhesive capsulitis,
weakness and atrophy, neuropathy, scar/skin adhesions, lymphedema), b) physical impairments
(diminished upper extremity and trunk range of motion/flexibility, strength, coordination
and increased girth), and c) functional imitations and disabilities during the course of the
medical treatment (loss of independence in or ability to perform routine activities of daily
living i.e., grooming, bathing, dressing, driving an automobile, and in some cases, return
to their regular work, recreational and social activities). 2) level of impairment at which
these patients have lost independence in function and identity those patients at higher risk
for the loss of independence in function (e.g., ADL's).

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 2000-2001, are eligible to participate in the study.

Subjects must be over age 18. This age ensures they are 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 five follow-up visits of 30 minutes in
duration during the next year.


Subject's medical records are unavailable and clinical examination forms are incomplete.

Subjects choose not to participate in the study.

Subjects are unable to complete the questionnaires.

Subjects are under age 18.

Men are not excluded from the study.

Type of Study:


Study Design:


Principal Investigator

Minal Jain, R.P.T.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institutes of Health Clinical Center (CC)


United States: Federal Government

Study ID:




Start Date:

November 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Conserving Surgery
  • Cancer
  • Functional Status
  • Lymphedema
  • Quality of Life
  • Breast Cancer
  • Breast Cancer Surgery
  • Breast Neoplasms



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892
National Naval Medical Center Bethesda, Maryland  20889