Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Orthopedic |
| Therapuetic Areas: | Oncology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/6/2019 |
| Start Date: | November 16, 2001 |
| End Date: | August 17, 2016 |
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 study will examine the frequency and severity of problems in women with breast cancer
during the first year after 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. Participants will be drawn from patients referred to the National Naval
Medical Center for diagnosis and treatment during 2000-20001.
Participants will be interviewed and their medical records reviewed for past medical history,
history of the present illness and social and recreational history. They will be seen five
times over a 1-year period (initial visit and at 3, 6, 9, and 12 months), for 30-minute
visits, which will include the following:
- Interview about past medical history and present illness, social and recreational
activities, functional independence at work and during activities of daily living.
- Complete health survey and upper limb disability questionnaire; physical activity
questionnaire to be completed at 6 and 12 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, an upper limb
lift test, and measures of upper limb volume and girth.
during the first year after 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. Participants will be drawn from patients referred to the National Naval
Medical Center for diagnosis and treatment during 2000-20001.
Participants will be interviewed and their medical records reviewed for past medical history,
history of the present illness and social and recreational history. They will be seen five
times over a 1-year period (initial visit and at 3, 6, 9, and 12 months), for 30-minute
visits, which will include the following:
- Interview about past medical history and present illness, social and recreational
activities, functional independence at work and during activities of daily living.
- Complete health survey and upper limb disability questionnaire; physical activity
questionnaire to be completed at 6 and 12 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, an upper limb
lift test, and measures of upper limb volume and girth.
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).
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.
EXCLUSION CRITERIA:
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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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