A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers
18 Years
N/A
Both
Advanced Cancer, Solid Tumors
Trial Information
A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Association between self-rated spirituality/religiosity and coping strategies
Outcome Time Frame:
Questionnaires completed by patient/caregiver at second consult visit, estimate 40 minutes to finish forms.
Safety Issue:
No
Principal Investigator
Eduardo Bruera, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2007-0678
NCT ID:
NCT00634257
Start Date:
February 2008
Completion Date:
August 2011
Related Keywords:
- Advanced Cancer
- Solid Tumors
- Advanced Cancer
- Solid Tumors
- Spirituality
- Religiosity
- Symptom Distress
- Quality of Life
- Caregivers
- Questionnaire
- Survey
- Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
