Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027118
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2001-11-20
Brief Title:
Morbidity After Diagnosis and Treatment of Breast Cancer Patients
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-08-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg 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
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 eg 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
Detailed Description:
Patients and healthy participants will undergo an interview at the beginning of the study and 1369 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CC-0045 | None | None | None |