- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07246954
A Chaplain-clinician Led Spiritual Care (PEACE) Intervention on Spiritual/Religious Beliefs Related to Medical Care in Patients With Advanced Cancer: a Pilot Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objectives
(Phase 1): To examine the feasibility and acceptability of a Chaplain-Clinician led spiritual care (PEACE: Perception, Exploring, Addressing, Compassionate Connection, Embracing) intervention in patients with advanced cancer admitted to a comprehensive cancer center in a single-arm pilot trial. Evaluation of feasibility will be per ≥70% participation in all sessions.
Acceptability will be assessed as ≥70% reporting satisfaction and ≥70% recommending PEACE intervention to others at the post-treatment assessment.
(Phase 2): To examine the within-group change in the influence of spiritual/religious beliefs on medical care (Question 2 in the Religious Beliefs in End-of-Life Medical Care [RBEC] tool: I will accept every possible medical treatment because my faith tells me to do everything I can to stay alive longer) from baseline to post-intervention assessments at 2 + 1 days in participants who participate in the PEACE intervention group and the usual care group.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marvin Delgado Guay, MD
- Phone Number: 713-745-8190
- Email: marvin.delgado@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- Marvin Delgado Guay, MD
- Phone Number: 713-745-8190
- Email: marvin.delgado@mdanderson.org
-
Principal Investigator:
- Marvin Delgado Guay, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Eligibility Criteria
- Participants with advanced cancer (locally advanced, metastatic, recurrent, or incurable) seen by the participant supportive/palliative care mobile team at MD Anderson Cancer Center.
- Respond "somewhat to A great deal" to the question in the RBEC questionnaire "I will accept every possible medical treatment because my faith tells me to do everything I can to stay alive longer".
- Participant s aged 18 years or over.
- Karnofsky performance status ≥30% at time of inclusion into study.
- Normal cognitive status as determined by the supportive care clinicians based on the ability to understand the nature of the study and consent process.
- Only English-speaking, as determined by their ability to understand the informed consent, the intervention, and the assessment tools.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phase 1
Patients will participate in two PEACE intervention sessions, which will last 30-60 minutes each.
|
Patients will participate in two PEACE intervention sessions, which will last 30-60 minutes each.
|
|
Experimental: Phase 2
Usual care is a comprehensive evaluation of the physical, emotional, and spiritual needs of the patient by the Supportive/Palliative Care medical team
|
Patients will participate in two PEACE intervention sessions, which will last 30-60 minutes each.
Usual care is a comprehensive evaluation of the physical, emotional, and spiritual needs of the patient by the Supportive/Palliative Care medical team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
RBEC Questionnaire
Time Frame: Through study completion; an average of 1 year
|
Through study completion; an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marvin Delgado Guay, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-1052
- NCI-2025-08254 (Other Identifier: NCI-CTRP Clinical Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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