Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00351988 |
| Other study ID # |
2005-0404 |
| Secondary ID |
5 KO7 CA 102482- |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 26, 2006 |
| Est. completion date |
January 20, 2022 |
Study information
| Verified date |
February 2022 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The primary objectives are to:
1.1 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
1.2 assess the relationship between caregiver's symptoms (physical and psychologic) and the
patient's symptom's at multiple time points over the patient's treatment regimen for advanced
solid tumors (lung, breast, cervical, and others).
A secondary objective is to:
1.3 describe the experience of being a minority (African American/Black 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 patient's treatment regimen and
follow-up clinic visits.
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.
