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Effects of Cancer Symptoms on Minority Caregivers


N/A
18 Years
N/A
Open (Enrolling)
Both
Psychosocial

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Trial Information

Effects of Cancer Symptoms on Minority Caregivers


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, M. D.
Anderson, and locations in the community identified by the participant and the study team.
Up to 40 will be enrolled at M. D. 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, M. D. Anderson
and locations in the community identified by the participant and study team. Up to 40 will
be enrolled at M. D. Anderson.


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Difference in reduction in psychological (depression, anxiety, stress) and physical symptoms (fatigue, sleep disturbance) between 3 groups of caregivers: African American, Latinos, and white non-Latinos

Outcome Time Frame:

20 weeks

Safety Issue:

No

Principal Investigator

Guadalupe Palos, DrPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005-0404

NCT ID:

NCT00351988

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Psychosocial
  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Breast Cancer
  • Psychosocial
  • Behavioral
  • Caregiver
  • Interview
  • Questionnaire
  • Minority Caregiver
  • Non-Minority Caregiver
  • Survey

Name

Location
Ben Taub General Hospital Houston, Texas  77030
U.T.M.D. Anderson Cancer Center Houston, Texas  77030
Jackson Memorial Miami, Florida  33136
Lyndon Baines Johnson Hospital Houston, Texas  77026