Spirituality/Religiosity in Patients and Caregivers
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/28/2018 |
| Start Date: | February 22, 2008 |
| End Date: | February 2021 |
A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers
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).
-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).
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.
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.
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:
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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