Psychosocial Clinical Trial
NCT00351988
| Observational
This study is looking to recruit 250 Participants
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.
Details for the study
Population
Three groups of caregivers: African American, Latinos, and white non-Latinos.
Brief Title
Effects of Cancer Symptoms on Caregivers
Official Title
Effects of Cancer Symptoms on Minority Caregivers
Brief Summary
The primary objectives are to:
<br />
<br /> 1.1 identify and compare the experiences of minority and nonminority caregivers, including
<br /> the prevalence and severity of physical (fatigue, sleep disturbance) and psychologic
<br /> (depression, anxiety, stress) symptoms and their influence on caregiver symptom burden; and
<br /> to
<br />
<br /> 1.2 assess the relationship between caregiver's symptoms (physical and psychologic) and the
<br /> patient's symptom's at multiple time points over the patient's treatment regimen for advanced
<br /> solid tumors (lung, breast, cervical, and others).
<br />
<br /> A secondary objective is to:
<br />
<br /> 1.3 describe the experience of being a minority (African American/Black or Latino) or
<br /> nonminority person caring for a medically underserved patient with advanced solids tumors
<br /> (lung, breast, cervical, or others) over the course of the patient's treatment regimen and
<br /> 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.
Treatments and/or Procedures
Quantitative interviews
Part 2 will collect quantitative data to determine the prevalence and severity of symptoms experienced by caregivers and their contribution to caregiver burden.
Phenomenological interviews
Part 1 will collect phenomenologic data to understand the meaning of caregiver burden, and the positive experiences faced when caring for a underserved patient with advanced lung cancer.
Study Criteria
Inclusion Criteria:
1. Caregiver inclusion criteria includes: provides care and/or assistance to a patient
receiving new or current treatment - Single or combined chemotherapy, radiotherapy,
and/or targeted therapy for advanced solid tumors (lung, breast, cervical, and other).
2. 18 years of age or older;
3. self-identified as African-American/Black, Latino, or white, non-Latino;
4. able to speak English or Spanish (as applicable);
5. able to read and complete forms or be willing to have the forms read to them by a
trained interviewer;
6. accessible through personal or telephone contact for the duration of the study.
7. Patient inclusion criteria: Receiving new or current treatment - Single or combined -
chemotherapy, radiotherapy, and/or targeted therapy for advanced solid tumors (lung,
breast, cervical, and others). Criteria 2-6 are the same as listed under Caregiver
Criteria.
Exclusion Criteria: None