Spirituality/Religiosity in Patients and Caregivers - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00634257

Purpose

Primary Objective:

To examine the association between self-rated spirituality/religiosity and coping strategies (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients.

Secondary Objectives:

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.
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).
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).
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).

Condition	Intervention
Advanced Cancer Solid Tumors	Behavioral: Questionnaires

MedlinePlus related topics: Cancer Caregivers Palliative Care

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Single Group Assignment
Official Title:	A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers

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

Primary Outcome Measures:

To learn about the spiritual and/or religious beliefs (if any) of patients with advanced cancer who are receiving palliative care. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To learn if and how these beliefs may impact patients' emotions and/or physical symptoms. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients with advanced cancer receiving palliative care.	Behavioral: Questionnaires Nine questionnaires taking about 40 minutes to complete.
2: Experimental Primary caregivers of Patients with advanced cancer receiving palliative care.	Behavioral: Questionnaires Nine questionnaires taking about 40 minutes to complete.

Eligibility

Criteria

Inclusion Criteria:

(Patients) Advanced cancer patients seen in palliative care outpatient clinic and palliative care mobile team and inpatient unit at M.D. Anderson Cancer Center
(Patients) Patients aged 18 years or over
(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).
(Patients) Able to provide informed consent and comply with study procedures
(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
(Caregivers) Having the patient's consent to be contacted.
(Caregivers) Caregiver is 18 years or over
(Caregivers) Able to provide informed consent and comply with study procedures
(Patients) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.
(Caregivers) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.
(Patients) Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634257

Contacts

Contact: Eduardo Bruera, MD

713-792-6085

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Eduardo Bruera, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Eduardo Bruera, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Eduardo Bruera, MD/Professor )
Study ID Numbers:	2007-0678
Study First Received:	February 25, 2008
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00634257 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Advanced Cancer
Solid Tumors
Spirituality
Religiosity
Symptom Distress

Quality of Life
Caregivers
Questionnaire
Survey

Study placed in the following topic categories:

Quality of Life

ClinicalTrials.gov processed this record on May 07, 2009