Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268502
Status:
COMPLETED
Last Update Posted:
2015-11-16
First Post:
2005-12-20
Brief Title:
Quality of Life in African-American or Caucasian Female Breast Cancer Survivors
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Survey of the Quality of Life of Women
Status:
COMPLETED
Status Verified Date:
2015-11
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:
RATIONALE Studying quality of life in cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future cancer survivors
PURPOSE This clinical trial is studying the quality of life in African-American or Caucasian female breast cancer survivors
PURPOSE This clinical trial is studying the quality of life in African-American or Caucasian female breast cancer survivors
Detailed Description:
OBJECTIVES
Compare disease-specific generic and global quality of life measures in African-American survivors of breast cancer with Caucasian survivors of breast cancer
Compare these quality of life measures in African-American survivors of breast cancer with control group of African-American women with no history of breast cancer
OUTLINE Patients and healthy participants complete a battery of quality of life QOL questionnaires over approximately 65 minutes by mail or over the phone including the Sexual Function Index Functional Assessment of Cancer Therapy - Fatigue Concerns About Recurrence Scale and other measures of symptomsside effects including sleep problems the RAND Physical Functioning -10 Scale Center for Epidemiologic Studies - Depression Scale assessment of family functionsocial support ENRICH Marital Satisfaction Scale Reed Spiritual Perspective Scale assessments of coping and body image Post-Traumatic Growth Inventory and the Index of Well-being Demographic disease treatment and comorbidity information as well as menstrual and gynecological history work status and insurance history and a measure of health care provider communication is collected using questionnaires and medical chart review
PROJECTED ACCRUAL A total of 195 patients and healthy participants will be accrued for this study
Compare disease-specific generic and global quality of life measures in African-American survivors of breast cancer with Caucasian survivors of breast cancer
Compare these quality of life measures in African-American survivors of breast cancer with control group of African-American women with no history of breast cancer
OUTLINE Patients and healthy participants complete a battery of quality of life QOL questionnaires over approximately 65 minutes by mail or over the phone including the Sexual Function Index Functional Assessment of Cancer Therapy - Fatigue Concerns About Recurrence Scale and other measures of symptomsside effects including sleep problems the RAND Physical Functioning -10 Scale Center for Epidemiologic Studies - Depression Scale assessment of family functionsocial support ENRICH Marital Satisfaction Scale Reed Spiritual Perspective Scale assessments of coping and body image Post-Traumatic Growth Inventory and the Index of Well-being Demographic disease treatment and comorbidity information as well as menstrual and gynecological history work status and insurance history and a measure of health care provider communication is collected using questionnaires and medical chart review
PROJECTED ACCRUAL A total of 195 patients and healthy participants will be accrued for this study
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 |
|---|---|---|---|
| CDR0000459904 | REGISTRY | None | None |
| IUMC-0502-01B | Registry Identifier | PDQ Physician Data Query | None |