Clinical trial NCT00634257: Spirituality/Religiosity in Patients and Caregivers
Official title: A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancer
Solid Tumors
Keywords: Advanced Cancer
Solid Tumors
Spirituality
Religiosity
Symptom Distress
Quality of Life
Caregivers
Questionnaire
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2008-03-12
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced cancer receiving palliative care and their primary caregivers.

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).

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.

Eligibility 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

Primary outcomes:
measure: Association between self-rated spirituality/religiosity and coping strategies
timeFrame: Questionnaires completed by patient/caregiver at second consult visit, estimate 40 minutes to finish forms.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Eduardo Bruera, MD
role: PRINCIPAL_INVESTIGATOR
References: