Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351988
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2006-07-12
Brief Title:
Effects of Cancer Symptoms on Caregivers
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Effects of Cancer Symptoms on Minority Caregivers
Status:
COMPLETED
Status Verified Date:
2022-02
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:
The primary objectives are to
11 identify and compare the experiences of minority and nonminority caregivers including the prevalence and severity of physical fatigue sleep disturbance and psychologic depression anxiety stress symptoms and their influence on caregiver symptom burden and to
12 assess the relationship between caregivers symptoms physical and psychologic and the patients symptoms at multiple time points over the patients treatment regimen for advanced solid tumors lung breast cervical and others
A secondary objective is to
13 describe the experience of being a minority African AmericanBlack or Latino or nonminority person caring for a medically underserved patient with advanced solids tumors lung breast cervical or others over the course of the patients treatment regimen and follow-up clinic visits
11 identify and compare the experiences of minority and nonminority caregivers including the prevalence and severity of physical fatigue sleep disturbance and psychologic depression anxiety stress symptoms and their influence on caregiver symptom burden and to
12 assess the relationship between caregivers symptoms physical and psychologic and the patients symptoms at multiple time points over the patients treatment regimen for advanced solid tumors lung breast cervical and others
A secondary objective is to
13 describe the experience of being a minority African AmericanBlack or Latino or nonminority person caring for a medically underserved patient with advanced solids tumors lung breast cervical or others over the course of the patients treatment regimen and follow-up clinic visits
Detailed Description:
Caregiver
If you choose to take part in this study you will be asked to complete 3 study visits over a period of about 20 weeks the first visit followed by 2 more visits usually 3-8 weeks apart During the first and third visits you will be asked to take part in an interview that will include questions about your experience as a caregiver to a patient with cancer The interview will last about 30-45 minutes and will be tape recorded The text of the interviews will be copied from the tapes to a written format The study staff will review the content to look for key caregiver concerns and experiences The PI and study staff will be the only ones who will have access to the tapes and transcripts All tapes will be destroyed after the study is finished
You will also be asked to complete some brief surveys about your physical and psychological health your reactions to being a caregiver and your beliefs about symptoms and their control It will take about 30-45 minutes to complete the surveys each time
Each study visit will take about 60-90 minutes If you can not come to the clinic trained research study staff will contact you by telephone or by a home visit with your permission to complete the surveys and interview After the last of the 3 study visits your participation will be ended in this study
This is an investigational study Up to 125 participants will take part in this multicenter study at 4 sites Lyndon Baines Johnson Hospital Ben Taub General Hospital MD Anderson and locations in the community identified by the participant and the study team Up to 40 will be enrolled at MD Anderson
Patient
If you choose to take part in this study you will be asked to complete 3 study visits over a period of about 20 weeks the first visit followed by 2 more visits usually 3-8 weeks apart During the visits you will also be asked to complete some surveys about your physical and psychological health your reactions to your caregiver and your beliefs about symptoms and their control It will take about 30 minutes to complete the surveys each time
Each study visit will take about 45 minutes If you can not come to the clinic trained research study staff will contact you by telephone or by a home visit with your permission to complete the surveys and interview After the last of the 3 study visits your participation in this study will end
This is an investigational study Up to 125 patients will take part in this multicenter study at 4 sites Lyndon Baines Johnson Hospital Ben Taub General Hospital MD Anderson and locations in the community identified by the participant and study team Up to 40 will be enrolled at MD Anderson
If you choose to take part in this study you will be asked to complete 3 study visits over a period of about 20 weeks the first visit followed by 2 more visits usually 3-8 weeks apart During the first and third visits you will be asked to take part in an interview that will include questions about your experience as a caregiver to a patient with cancer The interview will last about 30-45 minutes and will be tape recorded The text of the interviews will be copied from the tapes to a written format The study staff will review the content to look for key caregiver concerns and experiences The PI and study staff will be the only ones who will have access to the tapes and transcripts All tapes will be destroyed after the study is finished
You will also be asked to complete some brief surveys about your physical and psychological health your reactions to being a caregiver and your beliefs about symptoms and their control It will take about 30-45 minutes to complete the surveys each time
Each study visit will take about 60-90 minutes If you can not come to the clinic trained research study staff will contact you by telephone or by a home visit with your permission to complete the surveys and interview After the last of the 3 study visits your participation will be ended in this study
This is an investigational study Up to 125 participants will take part in this multicenter study at 4 sites Lyndon Baines Johnson Hospital Ben Taub General Hospital MD Anderson and locations in the community identified by the participant and the study team Up to 40 will be enrolled at MD Anderson
Patient
If you choose to take part in this study you will be asked to complete 3 study visits over a period of about 20 weeks the first visit followed by 2 more visits usually 3-8 weeks apart During the visits you will also be asked to complete some surveys about your physical and psychological health your reactions to your caregiver and your beliefs about symptoms and their control It will take about 30 minutes to complete the surveys each time
Each study visit will take about 45 minutes If you can not come to the clinic trained research study staff will contact you by telephone or by a home visit with your permission to complete the surveys and interview After the last of the 3 study visits your participation in this study will end
This is an investigational study Up to 125 patients will take part in this multicenter study at 4 sites Lyndon Baines Johnson Hospital Ben Taub General Hospital MD Anderson and locations in the community identified by the participant and study team Up to 40 will be enrolled at MD Anderson
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 |
|---|---|---|---|
| 5 KO7 CA 102482-02 | OTHER_GRANT | NCI | None |