Advanced CancerNCT06811376
Pilot Trial of Spiritual Care Interventions for Patients With Cancer
A study testing Spiritual Care Intervention #1 and Spiritual Care Intervention #2 in people with Advanced Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
This is a pilot trial of the effects of spiritual care interventions on spiritual well-being and readiness to engage in advance care planning (ACP) among black patients with advanced cancer recruited from outpatient settings to determine the feasibility of conducting a larger trial of effects of early integration of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Spiritual Care Intervention #1 and Spiritual Care Intervention #2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Feb 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with a life-limiting, advanced cancer.
- Identifies racially as black or African American.
- Is fluent in English.
Who cannot join
- Have received medical system-based spiritual care within the past 2 months.
- Have already completed a DNR order.
- Are too weak or cognitively impaired to engage in study activities
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Madison K Pavao, B.S., (646)962-5650, mkp4005@med.cornell.edu
- Recruiting
The University of Texas Medical Branch, Galveston
Galveston, Texas, 77555
Madison K Pavao, mkp4005@med.cornell.edu
About this study
This is a pilot trial of the effects of spiritual care interventions on spiritual well-being and readiness to engage in advance care planning (ACP) among black patients with advanced cancer recruited from outpatient settings to determine the feasibility of conducting a larger trial of effects of early integration of spiritual care into outpatient oncology care on patient outcomes.
Read the detailed description
This will be a pilot, stratified block randomized controlled trial of the effects of healthcare chaplain services on spiritual well-being and advance care planning (ACP) among black advanced cancer patients (N=64) in outpatient settings at two medical institutions: NYP/Brooklyn Methodist Hospital (BMH) and the University of Texas Medical Branch (UTMB). The investigators will randomly assign patients in a 1:1 ratio to either the Spiritual Care Intervention #1 or Spiritual Care Intervention #2 arm of the trial. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Trial outcomes will be assessed at the primary endpoint, 2 months after the onset of the spiritual care intervention.
- Conditions
- Advanced Cancer
- Being tested
- Spiritual Care Intervention #1, Spiritual Care Intervention #2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiritual Care Intervention #1Behavioural
Experimental
Spiritual Care Intervention #2Other
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Spiritual Care Intervention #1 | Experimental | This is the experimental condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Receives: Behavioral: Spiritual Care Intervention #1 |
| Spiritual Care Intervention #2 | Active comparator | This is the active comparator condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Receives: Other: Spiritual Care Intervention #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Spiritual Well-Being as assessed by Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale [FACIT-Sp].
The spiritual well-being outcome measure for this trial is the total score for the Spiritual Well-Being Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12-item Scale [FACIT-Sp-12], which has a range from 0 to 48. Higher scores mean greater spiritual well-being.
Measured: 2 months
Readiness to Engage in Advance Care Planning as assessed by the Advance Care Planning Engagement Survey.
The readiness to engage in advance care planning outcome measure for this trial is the average score of 4 items in the 4-item version of the Advance Care Planning Engagement Survey. Each item as well as the average score of the 4 items have a range of 1 to 5. Higher scores mean greater readiness to engage in ACP.
Measured: 2 months
Secondary outcomes (1)
Number of individual participants who complete a DNR order.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start13 Feb 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- New York Presbyterian Brooklyn Methodist Hospital, The University of Texas Medical Branch, Galveston, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Paul K Maciejewski, Ph.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811376
- Sponsor's protocol ID
- 23-10026611
- Other IDs
- R21MD017652
- Status last verified
- Mar 2026
- First submitted
- 31 Jan 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Spiritual Care Interventions for Patients With Cancer
- ClinicalTrials.gov ID
- NCT06811376
- Acronym / sponsor ID
- 23-10026611
- Conditions
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- New York Presbyterian Brooklyn Methodist Hospital, The University of Texas Medical Branch, Galveston, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot trial of the effects of spiritual care interventions on spiritual well-being and readiness to engage in advance care planning (ACP) among black patients with advanced cancer recruited from outpatient settings to determine the feasibility of conducting a larger trial of effects of early integration of spiritual care into outpatient oncology care on patient outcomes.
Detailed description
This will be a pilot, stratified block randomized controlled trial of the effects of healthcare chaplain services on spiritual well-being and advance care planning (ACP) among black advanced cancer patients (N=64) in outpatient settings at two medical institutions: NYP/Brooklyn Methodist Hospital (BMH) and the University of Texas Medical Branch (UTMB). The investigators will randomly assign patients in a 1:1 ratio to either the Spiritual Care Intervention #1 or Spiritual Care Intervention #2 arm of the trial. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Trial outcomes will be assessed at the primary endpoint, 2 months after the onset of the spiritual care intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spiritual Care Intervention #1 | Experimental | Behavioral: Spiritual Care Intervention #1This is the experimental condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. |
| Spiritual Care Intervention #2 | Active comparator | Other: Spiritual Care Intervention #2This is the active comparator condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with a life-limiting, advanced cancer.
- Identifies racially as black or African American.
- Is fluent in English.
Key exclusion criteria (3 listed)
- Have received medical system-based spiritual care within the past 2 months.
- Have already completed a DNR order.
- Are too weak or cognitively impaired to engage in study activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiritual Care Intervention #1Experimental | Behavioural | Spiritual Care Intervention #1 |
| Spiritual Care Intervention #2Active Comparator | Other | Spiritual Care Intervention #2 |
Primary outcome
Measure of Spiritual Well-Being as assessed by Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale [FACIT-Sp].
Time frame: 2 months
The spiritual well-being outcome measure for this trial is the total score for the Spiritual Well-Being Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12-item Scale [FACIT-Sp-12], which has a range from 0 to 48. Higher scores mean greater spiritual well-being.
Readiness to Engage in Advance Care Planning as assessed by the Advance Care Planning Engagement Survey.
Time frame: 2 months
The readiness to engage in advance care planning outcome measure for this trial is the average score of 4 items in the 4-item version of the Advance Care Planning Engagement Survey. Each item as well as the average score of the 4 items have a range of 1 to 5. Higher scores mean greater readiness to engage in ACP.
1 secondary outcome
Number of individual participants who complete a DNR order.
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul K Maciejewski, Ph.D. principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiritual Care Intervention #1 and Spiritual Care Intervention #2 in people with Advanced Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madison K Pavao, B.S. ((646)962-5650, mkp4005@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Spiritual Well-Being as assessed by Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale [FACIT-Sp]. (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.