Effects of Cancer Symptoms on Caregivers

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00351988
First received: July 12, 2006
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Psychosocial
Behavioral: Phenomenological Interviews
Behavioral: Quantitative Interviews

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effects of Cancer Symptoms on Minority Caregivers

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2006
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
African American caregivers
African American caregivers for patients with advanced non-small cell lung cancer or breast cancer.
Behavioral: 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.
Behavioral: 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.
Other Name: Questionnaire
Latino caregivers
Latino caregivers for patients with advanced non-small cell lung cancer or breast cancer.
Behavioral: 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.
Behavioral: 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.
Other Name: Questionnaire
White non-Latino caregivers
White non-Latino caregivers for patients with advanced non-small cell lung cancer or breast cancer.
Behavioral: 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.
Behavioral: 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.
Other Name: Questionnaire

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Three groups of caregivers: African American, Latinos, and white non-Latinos.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351988

Contacts
Contact: Guadalupe Palos, DrPH 713-745-3470

Locations
United States, Florida
Jackson Memorial Recruiting
Miami, Florida, United States, 33136
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Guadalupe Palos, DrPH         
Lyndon Baines Johnson Hospital Recruiting
Houston, Texas, United States, 77026
Ben Taub General Hospital Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Guadalupe Palos, DrPH M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00351988     History of Changes
Other Study ID Numbers: 2005-0404
Study First Received: July 12, 2006
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Non-Small Cell Lung Cancer
Breast Cancer
Caregiver
Minority Caregiver
Non-Minority Caregiver
Psychosocial
Behavioral
Interview
Questionnaire
Survey

ClinicalTrials.gov processed this record on July 22, 2014