Expired Study
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Houston, Texas 77030


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).


Study summary:

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.


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


Study is Available At:


Original ID:

2007-0678


NCT ID:

NCT00634257


Secondary ID:

NCI-2011-02785


Study Acronym:


Brief Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

193


Enrollment Type:

Actual


Overall Contact Information

Official Name:Eduardo Bruera, MD
Principal Investigator
M.D. Anderson Cancer Center

Study Dates

Start Date:February 22, 2008
Completion Date:February 2021
Completion Type:Anticipated
Primary Completion Date:February 2020
Primary Completion Type:Anticipated
Verification Date:May 2019
Last Changed Date:May 10, 2019
First Received Date:February 25, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Questionnaires
Description:Nine questionnaires taking about 40 minutes to complete.
Arm Name:Patients
Other Name:Survey

Study Arms

Study Arm Type:Other
Arm Name:Caregivers
Description:Primary caregivers of Patients with advanced cancer receiving palliative care.
Study Arm Type:Other
Arm Name:Patients
Description:Patients with advanced cancer receiving palliative care.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center

Samples and Retentions

Study Population: Patients with advanced cancer receiving palliative care and their primary caregivers.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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