Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spirituality/Religiosity in Patients and Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00634257
Recruitment Status : Active, not recruiting
First Posted : March 12, 2008
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment
Advanced Cancer Solid Tumors Behavioral: Questionnaires

Detailed Description:

Questionnaires:

If you are found to be eligible to take part in this study and you agree to take part, you will complete 9 questionnaires.

The first 2 questionnaires ask about your demographic information (such as your education level and age) and the symptoms of cancer you may be experiencing.

The 6 other questionnaires ask questions about several subjects. You will be asked about your religious/spiritual beliefs, such as your way of coping with cancer and whether you have focused on religion/spirituality or other strategies in order to stop worrying. You will also be asked whether you feel religious/spiritual beliefs are important in your everyday life, how hopeful you may feel, and the level of spiritual pain you may feel. (Some people experience spiritual pain as a deep pain in the "soul" or "being" that is not physical pain.)

The last questionnaire asks about any symptoms of anxiety or depression you may feel. In total, these questionnaires should take about 40 minutes to complete.

Length of Study Participation:

After completing the questionnaires, your participation in this study will be over.

This is an investigational study. Up to 100 patients and 100 caregivers will take part in this study. All will be enrolled at M. D. Anderson.


Layout table for study information
Study Type : Observational
Actual Enrollment : 193 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers
Actual Study Start Date : February 22, 2008
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients
Patients with advanced cancer receiving palliative care.
Behavioral: Questionnaires
Nine questionnaires taking about 40 minutes to complete.
Other Name: Survey

Caregivers
Primary caregivers of Patients with advanced cancer receiving palliative care.
Behavioral: Questionnaires
Nine questionnaires taking about 40 minutes to complete.
Other Name: Survey




Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced cancer receiving palliative care and their primary caregivers.
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.

Exclusion Criteria:

N/A


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634257


Locations
Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Eduardo Bruera, MD M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00634257     History of Changes
Other Study ID Numbers: 2007-0678
NCI-2011-02785 ( Registry Identifier: NCI CTRP )
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Solid Tumors
Spirituality
Religiosity
Symptom Distress
Quality of Life
Caregivers
Questionnaire
Survey