MDACC Study Summary 2005-0404

Study Summary
No. 2005-0404:.......Psychosocial......Guadalupe Palos......Symptom Research

Study Summary Title



Study Summary Number:	2005-0404

Study Title:	Effects of Cancer Symptoms on Caregivers

Physician

New Patient Referral



Name:	Guadalupe Palos	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Symptom Research	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3470 Contact us about clinical trials

General Information



Disease Group:	Psychosocial	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Caregivers and patients from MDACC - 2 visits (plus baseline visit) Caregivers and patients from other sites - 2 visits (plus baseline)

Treatment Agents:	Interview Questionnaire	Home Care:	Not applicable - this is not a treatment plan.

Treatment Loc:	MDACC + Community Programs (CCOP/Network)

Estimated Length of Stay in Houston:	Not applicable

Description/
Intervention:

The goal of this psychosocial research study is to learn about the physical
and psychological symptoms, as well as any special needs, that family or
friend caregivers experience during the times they are caring for patients with
symptoms related to treatment for advanced cancer. Researchers will also study
the caregivers' physical and psychological response to changes in the patient's
symptoms over time. Another goal is to learn how a person manages the multiple
roles required of a caregiver, by asking questions about their experience and
its meaning to them.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:	01/26/2006

IRB Review and Approval Date:	06/15/2005

Study Type:	Not Applicable

Recruitment Status:	Closed

Projected Accrual:	250 (125 dyads or 125 caregivers and 125 patients)

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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:

N/A

Links

Registration Number: NCT00351988
Study Information on Clinical Trials Registry (clinicaltrials.gov)