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Study Summary
No. 2007-0678:.......Advanced Cancers......Eduardo Bruera......Palliative Care & Rehabilitation Medicine
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Study Summary Title
Study Summary
Number:		2007-0678
Study Title:A preliminary study of spirituality/religiosity, symptom distress and quality of life among palliative care patients and their primary caregivers
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Physician New Patient Referral
Name:Eduardo BrueraPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Palliative Care & Rehabilitation MedicineReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6085
Contact us about clinical trials
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General Information
Disease Group:Advanced CancersSupported By:N/A
Phase of Study:N/AReturn
Visit:		Only one time interview
Treatment
Agents:		NoneHome Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this research study is to learn about the spiritual and/or
religious beliefs (if any) of patients with advanced cancer who are receiving
palliative care. Researchers want to learn if the beliefs may affect these
patients' way of coping with cancer. Researchers also want to learn if and how
these beliefs may impact patients' emotions and/or physical symptoms.

Patients' caregivers will also be asked if their own spiritual and/or religious
beliefs, if any, may impact their emotions and/or physical well-being such as
sleep function.
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Study Objectives / Outcomes
Primary Objectives
1. To examine the association between self-rated spirituality/religiosity and coping strategies (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients.

Secondary Objectives
1. To examine the associations between self-rated spirituality/religiosity and physical (ESAS) and psychological symptom reports (HADS), and quality of life (FACIT-sp) among palliative care patients.
2. To examine the association between patient's self-reported spirituality/religiosity, and primary caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire, FACIT-sp).
3. To determine the frequency (self-rated spiritual pain scale when score is more or equal than 1 in the scale 0 to 10) and intensity of self-rated spiritual pain in the palliative care setting and to explore the association between spiritual pain, and negative religious coping (Brief RCOPE), physical (ESAS) and psychological symptoms (HADS), and primary caregiver distress (CQLS-C, caregiver self-assessment questionnaire).
4. To examine the association between primary caregivers' spirituality/religiosity (Appendix H, first question), religious coping strategies (Brief-RCOPE) and psychological and family/caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire), and caregivers' spiritual pain (Appendix F, second question).
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Study Status Information
Study Activation / Registration Date:02/22/2008
IRB Review and Approval Date:02/22/2008
Study Type:Other
Recruitment Status:Terminated
Projected Accrual:N/A
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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) (Patients) Advanced cancer patients seen in palliative care outpatient clinic and palliative care mobile team and inpatient unit at M.D. Anderson Cancer Center

2) (Patients) Patients aged 18 years or over

3) (Patients) Karnofsky performance status score of more than 40 at time of inclusion into study. (Patients with Karnofsky score less than 40 may not be able to complete the measures).

4) (Patients) Able to provide informed consent and comply with study procedures

5) (Caregivers) Spouse, first degree relative, or other person designated by the patient as providing direct assistance to the patient in his/her activities of daily living

6) (Caregivers) Having the patient's consent to be contacted.

7) (Caregivers) Caregiver is 18 years or over

8) (Caregivers) Able to provide informed consent and comply with study procedures

9) (Patients) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.

10) (Caregivers) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.

11) (Patients) Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.
Exclusion Criteria:N/A
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Links
Registration Number: NCT00634257
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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