Advanced CancerNCT07408310
Trial of Spiritual Care Interventions for Patients With Cancer
A study testing Spiritual Care Intervention #1, Spiritual Care Intervention #2 and Spiritual Care Intervention #3 in people with Advanced Cancer, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
This study aims to determine the effects of 2 spiritual care interventions. Spiritual wellness and healthcare service utilization will be measured from a sample of advanced cancer patients recruited from outpatient settings. 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, Spiritual Care Intervention #2 and Spiritual Care Intervention #3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Mar 2026to Jun 2029
- 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
None listed.
Who cannot join
- Received spiritual care from a healthcare chaplain within the past 2 months.
- Too weak or cognitively impaired to engage in study activities.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The University of Texas Medical Branch, Galveston
Galveston, Texas, 77555
Mukaila Raji, M.D., (409) 772-1989, muraji@UTMB.EDU
Mukaila Raji, M.D.
- Recruiting
M.D. Anderson Cancer Center
Houston, Texas, 77030
David Hui, M.D., (713) 563-7630, DHui@mdanderson.org
David Hui, M.D.
- Recruiting
New York Presbyterian Brooklyn Methodist Hospital
New York, New York, 11215
Alan B Astrow, M.D., (718) 780-5824, ala9124@med.cornell.edu
Alan B Astrow, M.D.
About this study
This study aims to determine the effects of 2 spiritual care interventions. Spiritual wellness and healthcare service utilization will be measured from a sample of advanced cancer patients recruited from outpatient settings.
Read the detailed description
This study is a stratified permuted-block RCT to determine the effects of 2 spiritual care interventions on advanced cancer patients' spiritual wellness (i.e., spiritual well-being and satisfaction of spiritual care needs) and specific forms of healthcare service utilization (i.e., hospice enrollment and ICU admissions) in a sample of advanced cancer patients (N=288) recruited from outpatient settings. Patients will be assigned to "Spiritual Care Intervention #1" (active 1), "Spiritual Care Intervention #2" (active 2), or "Spiritual Care Intervention #3" (control) arm of the trial (overall ratio 1:1:1) using permuted-block randomization within strata defined by geographic location (NYC, Houston Metro Area) and recruitment site (NYC: BMH; Houston Metro Area: UTMB, MDACC). Spiritual care intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Only 1 of the 2 active interventions will be administered at each site at a given time to avoid within-site cross-contamination between the 2 active intervention arms of the trial.
- Conditions
- Advanced Cancer
- Being tested
- Spiritual Care Intervention #1, Spiritual Care Intervention #2, Spiritual Care Intervention #3
- Keywords
- Advanced Cancer, Spiritual Care
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 #2Behavioural
Experimental
Spiritual Care Intervention #3Behavioural
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Spiritual Care Intervention #1 | Experimental | This is an 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 | Experimental | This is also an 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 #2 |
| Spiritual Care Intervention #3 | 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: Behavioral: Spiritual Care Intervention #3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' spiritual wellness as assessed by measures of spiritual well-being
The spiritual well-being outcome measure for this trial is the total score for the 12-item Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale [FACIT-Sp-12], which has a range from 0 to 48. The higher the score, the greater the spiritual well-being.
Measured: 2 months
Participants' number of hospice enrollments
Number of hospice enrollments over time, up to 12 months.
Measured: up to 12 months
Participants' number of ICU admissions
Number of ICU admissions over time, up to 12 months.
Measured: up to 12 months
Patients' spiritual wellness as assessed by measures of satisfaction of spiritual care needs.
The satisfaction of spiritual care needs outcome measure for this trial is a reverse-coded total score for the 13-item Spiritual Needs Assessment for Patients [SNAP], which measures unmet spiritual care needs and has a range from 13 to 52. The higher the reverse-coded score, the greater the satisfaction of spiritual care needs.
Measured: 2 months
Secondary outcomes (1)
Patients' quality of life
The quality-of-life outcome measure for this trial is the total score for the 27-item Functional Assessment of Cancer Therapy - General [FACT-G], which has a range of 0 to 108. The higher the score, the greater the quality of life.
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 posted13 Feb 2026
- Study start24 Mar 2026
- Primary completionApr 2029 (estimated)
- Study completionJun 2029 (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
- Model description
- Patients will be assigned to "Spiritual Care Intervention #1" (active 1), "Spiritual Care Intervention #2" (active 2), or "Spiritual Care Intervention #3" (control) arm of the trial (overall ratio 1:1:1) using permuted-block randomization within strata defined by geographic location (NYC, Houston Metro Area) and recruitment site (NYC: BMH; Houston Metro Area: UTMB, MDACC).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), New York Presbyterian Brooklyn Methodist Hospital, The University of Texas Medical Branch, Galveston, M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Paul K Maciejewski, Ph.D., Principal investigator, Weill Medical College of Cornell UniversityAlan B Astrow, M.D., Principal investigator, NYP Brooklyn Methodist HospitalMukaila Raji, M.D., Principal investigator, The University of Texas Medical BranchDavid Hui, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408310
- Sponsor's protocol ID
- 24-08027855
- Other IDs
- R01NR021159
- Status last verified
- Jun 2026
- First submitted
- 29 Jan 2026
- Last updated
- 2 Jun 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Spiritual Care Interventions for Patients With Cancer
- ClinicalTrials.gov ID
- NCT07408310
- Acronym / sponsor ID
- 24-08027855
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, Spiritual Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), New York Presbyterian Brooklyn Methodist Hospital, The University of Texas Medical Branch, Galveston, M.D. Anderson Cancer Center
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 13 Feb 2026 (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 study aims to determine the effects of 2 spiritual care interventions. Spiritual wellness and healthcare service utilization will be measured from a sample of advanced cancer patients recruited from outpatient settings.
Detailed description
This study is a stratified permuted-block RCT to determine the effects of 2 spiritual care interventions on advanced cancer patients' spiritual wellness (i.e., spiritual well-being and satisfaction of spiritual care needs) and specific forms of healthcare service utilization (i.e., hospice enrollment and ICU admissions) in a sample of advanced cancer patients (N=288) recruited from outpatient settings. Patients will be assigned to "Spiritual Care Intervention #1" (active 1), "Spiritual Care Intervention #2" (active 2), or "Spiritual Care Intervention #3" (control) arm of the trial (overall ratio 1:1:1) using permuted-block randomization within strata defined by geographic location (NYC, Houston Metro Area) and recruitment site (NYC: BMH; Houston Metro Area: UTMB, MDACC). Spiritual care intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Only 1 of the 2 active interventions will be administered at each site at a given time to avoid within-site cross-contamination between the 2 active intervention arms of the trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be assigned to "Spiritual Care Intervention #1" (active 1), "Spiritual Care Intervention #2" (active 2), or "Spiritual Care Intervention #3" (control) arm of the trial (overall ratio 1:1:1) using permuted-block randomization within strata defined by geographic location (NYC, Houston Metro Area) and recruitment site (NYC: BMH; Houston Metro Area: UTMB, MDACC).
| Arm | Type | Receives |
|---|---|---|
| Spiritual Care Intervention #1 | Experimental | Behavioral: Spiritual Care Intervention #1This is an experimental condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. |
| Spiritual Care Intervention #2 | Experimental | Behavioral: Spiritual Care Intervention #2This is also an experimental condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. |
| Spiritual Care Intervention #3 | Active comparator | Behavioral: Spiritual Care Intervention #3This 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 (0 listed)
Key exclusion criteria (2 listed)
- Received spiritual care from a healthcare chaplain within the past 2 months.
- 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 #2Experimental | Behavioural | Spiritual Care Intervention #2 |
| Spiritual Care Intervention #3Active Comparator | Behavioural | Spiritual Care Intervention #3 |
Primary outcome
Patients' spiritual wellness as assessed by measures of spiritual well-being
Time frame: 2 months
The spiritual well-being outcome measure for this trial is the total score for the 12-item Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale [FACIT-Sp-12], which has a range from 0 to 48. The higher the score, the greater the spiritual well-being.
Participants' number of hospice enrollments
Time frame: up to 12 months
Number of hospice enrollments over time, up to 12 months.
Participants' number of ICU admissions
Time frame: up to 12 months
Number of ICU admissions over time, up to 12 months.
Patients' spiritual wellness as assessed by measures of satisfaction of spiritual care needs.
Time frame: 2 months
The satisfaction of spiritual care needs outcome measure for this trial is a reverse-coded total score for the 13-item Spiritual Needs Assessment for Patients [SNAP], which measures unmet spiritual care needs and has a range from 13 to 52. The higher the reverse-coded score, the greater the satisfaction of spiritual care needs.
1 secondary outcome
Patients' quality of life
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 2 Jun 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
Alan B Astrow, M.D. principal investigator
NYP Brooklyn Methodist Hospital
Mukaila Raji, M.D. principal investigator
The University of Texas Medical Branch
3 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, Spiritual Care Intervention #2 and Spiritual Care Intervention #3 in people with Advanced Cancer, run by Weill Medical College of Cornell University at 3 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 0 inclusion and 2 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Patients' spiritual wellness as assessed by measures of spiritual well-being (time frame: 2 months). The study lists 4 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 2 Jun 2026.