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Spirituality/Religiosity in Patients and Caregivers
This study is ongoing, but not recruiting participants.
First Received: February 25, 2008   Last Updated: July 31, 2009   History of Changes
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

Study Type: Interventional
Study Design: Supportive Care, Non-Randomized, 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Caregivers Palliative Care
U.S. FDA Resources

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

Primary Outcome Measures:
  • Association between self-rated spirituality/religiosity and coping strategies [ Time Frame: Questionnaires completed by patient/caregiver at second consult visit, estimate 40 minutes to finish forms. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2008
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patients: Experimental
Patients with advanced cancer receiving palliative care.
Behavioral: Questionnaires
Nine questionnaires taking about 40 minutes to complete.
Caregivers: Experimental
Primary caregivers of Patients with advanced cancer receiving palliative care.
Behavioral: Questionnaires
Nine questionnaires taking about 40 minutes to complete.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
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: July 31, 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 September 10, 2009



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