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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)


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

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 longitudinal, prospective (cohort) outcome study will describe the frequency and
severity of morbidities and investigate the risk factors for development of morbidity
defined as upper limb impairments, functional limitations and disability in a treatment
group of approximately 300 patients diagnosed with breast cancer before and after medical
and surgical treatment compared to a control group of 300 healthy women.

Subjects will be followed for two-years with periodic examinations (baseline
[pre-surgical/medical treatment] and at 1, 3, 6, 12, 18 and 24 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 (2 years 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 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 symptom distress and 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 five year longitudinal,
prospective design that includes a control groups, 2) specific patient process variables
such as demographics, medical data, e.g. staging conference information, and the standard
upper body clinical examination, and 2) administration of self-report surveys/questionnaires
that measure upper limb functional limitations and disabilities, physical activity and
quality of life at baseline and follow-up at 1, 3, 6, 12, 18 and 24 months. 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
identify those patients at higher risk for the loss of independence in function (e.g.
ADL's), and

3. risk factors for loss of function and disability.

Inclusion Criteria


- 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Minal Jain, R.P.T.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institutes of Health Clinical Center (CC)

Authority:

United States: Federal Government

Study ID:

020045

NCT ID:

NCT00027118

Start Date:

November 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Conserving Surgery
  • Functional Status
  • Cancer
  • Lymphedema
  • Quality of Life
  • Breast Cancer
  • Breast Cancer Surgery
  • Healthy Volunteer
  • HV
  • Normal Control
  • Breast Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892
National Naval Medical CenterBethesda, Maryland  20889