CancerPhase 3SPCNCT07290491
Spiritual Care or Psychotherapy Versus Palliative Care Alone in Patients With Non-Curative Malignancies
A Phase 3 study testing Chaplain-Provided Spiritual Care and Psychotherapy and Meditation Intervention in people with Cancer, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
This phase III clinical trial will evaluate the impact on survival of adding chaplain-provided spiritual care or psychotherapy/meditation to standard-of-care (SOC) and palliative measures, plus chemotherapy if recommended, and comparing it with SOC and palliative measures, plus chemotherapy if recommended, in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Chaplain-Provided Spiritual Care and Psychotherapy and Meditation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 854 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2024to 10 May 2030
- Phase
- Phase 3
- 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
- Patients are eligible to be included in the trial only if all of the following criteria apply
- The patient provides written informed consent for the trial.
- Male or female ≥18 years of age on the day of informed consent signing.
- Histologically confirmed metastatic disease with life expectancy of one year or less.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
- Willing and able to comply with the protocol for the duration of the trial including undergoing scheduled visits and interventions.
Who cannot join
- Patients are excluded from the trial if any of the following criteria apply:
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. If a patient develops a psychiatric disorder after baseline, he/she will not be taken off the trial.
- Mobility limitations that would interfere with cooperation with the requirements of the trial.
- Confirmed positive pregnancy test in women of child bearing potential.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Neal Cancer Center
Houston, Texas, 77030
Hanh Mai, MD
About this study
Official title: Impact on Survival of Chaplain Provided Spiritual Care or Psychotherapy Combined With Palliative Care Versus Palliative Care Alone in Patients With Non-Curative Malignancies
This phase III clinical trial will evaluate the impact on survival of adding chaplain-provided spiritual care or psychotherapy/meditation to standard-of-care (SOC) and palliative measures, plus chemotherapy if recommended, and comparing it with SOC and palliative measures, plus chemotherapy if recommended, in patients with non-curative malignancies. The Palliative Care Department at Houston Methodist Hospital provides essential services to patients diagnosed with advanced cancer by sharing information and resources about symptom management, pain treatment and planning for the future. It is also recognized that chaplaincy-based spiritual care of patients can be a valuable part of interdisciplinary interventions in oncology.
- Conditions
- Cancer
- Being tested
- Chaplain-Provided Spiritual Care, Psychotherapy and Meditation Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chaplain-Provided Spiritual CareBehavioural
Patients will receive 24 individual, one-on-one sessions with a board -certified chaplain.
The goal of these sessions is to elicit the spiritual, existential, and emotional issues or distress arising from your experience of cancer and draw on intrapsychic, spiritual, and narrative resources to develop a sense of meaning of your experience that is aligned with your spiritual and existential values and outlook. Rituals often function as actions to stabilize and support persons experiencing stressful or traumatic moments as well as provide structure for meaning making. The practice of rituals will be included in these sessions as a means of integrating bodily experience into reflection as well as providing a resource for ongoing spiritual support. Rituals may include prayer practices, guided imagery, use of journaling, creation of legacy items, sacred readings, poetry, or other personalized rituals.
Psychotherapy and Meditation InterventionBehavioural
24 individual, one-on-one psychotherapy/ meditation sessions with a licensed psychotherapist and a meditation instructor.
Psychotherapy, or talk therapy, is an approach for addressing stresses and emotional conflicts in life by talking with a therapist. During psychotherapy, patients will be able to discuss specific challenges in your life and will work with a psychotherapist to develop helpful coping skills. Guided Visualization Meditation will be combined with psychotherapy to help you relax the body and clear the mind. Patients will be guided by an experienced instructor to cultivate a personal sense of inner calm.
In these psychotherapy/meditation sessions you will determine the pace that you would like to follow and how deeply you wish to engage with the practice. The sessions will be interactive, and the psychotherapist/meditation instructor will respond to your needs and preferences.
| Study group | Role | What they receive |
|---|---|---|
| Spiritual Care or Psychotherapy/Meditation with SoC and Palliative Measures, plus Chemotherapy | Experimental | Patients will receive either individual spiritual care from a Houston Methodist Hospital chaplain or personal psychotherapy/meditation from a psychotherapist/ meditation instructor in addition to Standard of Care and Palliative Measures, plus Chemotherapy if recommended for 24 sessions (one hour per session) over 24 weeks, per patients' choice. Receives: Behavioral: Chaplain-Provided Spiritual Care; Behavioral: Psychotherapy and Meditation Intervention |
| Standard of Care and Palliative Measures, plus Chemotherapy | No intervention | Patients will receive Standard of Care and palliative measures, plus chemotherapy if recommended over 24 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the overall survival (OS) of patients with non-curative malignancies
To determine the overall survival (OS) of patients with non-curative malignancies who receive chaplain-provided spiritual care or psychotherapy/ meditation in addition to SOC and palliative measures, plus chemotherapy if recommended.
Measured: From start of intervention till the date of death, up to 30 days after completing intervention
Secondary outcomes (11)
Patient-reported quality of life assessed by the FACT-G questionnaire.
FACT-G (Functional Assessment of Cancer Therapy- General) Version 4. Score values range from 0 to 135. Higher score means better outcome.
Measured: Assessed at baseline and after interventions are completed, up to 24 weeks
Patient-reported quality of life assessed by the DASS-42 questionnaire.
DASS-42 (Depression, Anxiety and Stress Scale). Score values range from 0 to 126. Higher score means worse outcome.
Measured: Assessed at baseline and after interventions are completed, up to 24 weeks
Patient-reported quality of life assessed by the AAQ questionnaire.
AAQ (Acceptance and Action Questionnaire II). Score values range from 7 to 49. Higher score means worse outcome.
Measured: Assessed at baseline and after interventions are completed, up to 24 weeks
Patient-reported quality of life assessed by the ACE questionnaire.
ACE (Adverse Childhood Experience). Values range from 0 if no, and 1 if yes to any question. Higher score means worse outcome.
Measured: Assessed at baseline and after interventions are completed, up to 24 weeks
Patient-reported quality of life assessed by the FACIT-Sp-Ex questionnaire.
FACIT-Sp-Ex (Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Expanded Version). Score values range from 0 to 92. Higher score means better outcome.
Measured: Assessed at baseline and after interventions are completed, up to 24 weeks
Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section A - Burnout.
MBI (Maslach Burnout Inventory). Section A burnout score values range from 0 to 42. Higher score means worse outcome.
Measured: From initial assessment until final assessments are completed, every 6 months, up to 60 months
Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section B - Depersonalization.
MBI (Maslach Burnout Inventory). Section B Depersonalization score values range from 0 to 42. Higher score means worse outcome.
Measured: From initial assessment until final assessments are completed, every 6 months, up to 60 months
Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section C - Personal Achievement.
MBI (Maslach Burnout Inventory). Section C Personal Achievement score values range from 0 to 48. Higher score means better outcome.
Measured: From initial assessment until final assessments are completed, every 6 months, up to 60 months
Self-reported caretaker/physician burnout as assessed by the PROMIS questionnaire.
PROMIS (Patient-Reported Outcomes Measurement Information System -Depression and Anxiety). Depression score values range from 8 to 40. This value is t-scored and a higher score means worse outcome. Anxiety score values range from 7 to 35. This value is t-scored and a higher score means worse outcome.
Measured: From initial assessment until final assessments are completed, every 6 months, up to 60 months
Self-reported caretaker/physician burnout as assessed by the PFI questionnaire - Professional Fulfillment.
PFI (Professional Fulfillment Index). Questions 1-6 sum values range from 0 to 24. A higher score means better outcome.
Measured: From initial assessment until final assessments are completed, every 6 months, up to 60 months
Self-reported caretaker/physician burnout as assessed by the PFI questionnaire - Burnout.
PFI (Professional Fulfillment Index). Questions 7-16 sum values range from 0 to 40. A higher score means worse outcome.
Measured: From initial assessment until final assessments are completed, every 6 months, up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start19 Jun 2024
- Primary completion10 May 2029 (estimated)
- Study completion10 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 854 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanh Mai, The Methodist Hospital Research Institute
- Investigators
- Hanh Mai, DO, Principal investigator, Houston Methodist Neal Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290491
- Sponsor's protocol ID
- PRO00037917 (HMCC-BR23-001)
- Acronym
- SPC
- Status last verified
- Dec 2025
- First submitted
- 9 Aug 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Survival of Chaplain Provided Spiritual Care or Psychotherapy Combined With Palliative Care Versus Palliative Care Alone in Patients With Non-Curative Malignancies
- ClinicalTrials.gov ID
- NCT07290491
- Acronym / sponsor ID
- SPC / PRO00037917 (HMCC-BR23-001)
- Conditions
- Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 854 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 10 May 2029 (estimated)
- Study completion
- 10 May 2030 (estimated)
- First posted
- 18 Dec 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 phase III clinical trial will evaluate the impact on survival of adding chaplain-provided spiritual care or psychotherapy/meditation to standard-of-care (SOC) and palliative measures, plus chemotherapy if recommended, and comparing it with SOC and palliative measures, plus chemotherapy if recommended, in patients with non-curative malignancies. The Palliative Care Department at Houston Methodist Hospital provides essential services to patients diagnosed with advanced cancer by sharing information and resources about symptom management, pain treatment and planning for the future. It is also recognized that chaplaincy-based spiritual care of patients can be a valuable part of interdisciplinary interventions in oncology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spiritual Care or Psychotherapy/Meditation with SoC and Palliative Measures, plus Chemotherapy | Experimental | Behavioral: Chaplain-Provided Spiritual Care, Behavioral: Psychotherapy and Meditation InterventionPatients will receive either individual spiritual care from a Houston Methodist Hospital chaplain or personal psychotherapy/meditation from a psychotherapist/ meditation instructor in addition to Standard of Care and Palliative Measures, plus Chemotherapy if recommended for 24 sessions (one hour per session) over 24 weeks, per patients' choice. |
| Standard of Care and Palliative Measures, plus Chemotherapy | No intervention | –Patients will receive Standard of Care and palliative measures, plus chemotherapy if recommended over 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients are eligible to be included in the trial only if all of the following criteria apply
- The patient provides written informed consent for the trial.
- Male or female ≥18 years of age on the day of informed consent signing.
- Histologically confirmed metastatic disease with life expectancy of one year or less.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
Key exclusion criteria (4 listed)
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. If a patient develops a psychiatric disorder after baseline, he/she will not be taken off the trial.
- Mobility limitations that would interfere with cooperation with the requirements of the trial.
- Confirmed positive pregnancy test in women of child bearing potential.
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 |
|---|---|---|
| Chaplain-Provided Spiritual CarePatients will receive 24 individual, one-on-one sessions with a board -certified chaplain. The goal of these sessions is to elicit the spiritual, existential, and emotional issues or distress arising from your experience of cancer and draw on intrapsychic, spiritual, and narrative resources to develop a sense of meaning of your experience that is aligned with your spiritual and existential values and outlook. Rituals often function as actions to stabilize and support persons experiencing stressful or traumatic moments as well as provide structure for meaning making. The practice of rituals will be included in these sessions as a means of integrating bodily experience into reflection as well as providing a resource for ongoing spiritual support. Rituals may include prayer practices, guided imagery, use of journaling, creation of legacy items, sacred readings, poetry, or other personalized rituals. | Behavioural | Spiritual Care or Psychotherapy/Meditation with SoC and Palliative Measures, plus Chemotherapy |
| Psychotherapy and Meditation Intervention24 individual, one-on-one psychotherapy/ meditation sessions with a licensed psychotherapist and a meditation instructor. Psychotherapy, or talk therapy, is an approach for addressing stresses and emotional conflicts in life by talking with a therapist. During psychotherapy, patients will be able to discuss specific challenges in your life and will work with a psychotherapist to develop helpful coping skills. Guided Visualization Meditation will be combined with psychotherapy to help you relax the body and clear the mind. Patients will be guided by an experienced instructor to cultivate a personal sense of inner calm. In these psychotherapy/meditation sessions you will determine the pace that you would like to follow and how deeply you wish to engage with the practice. The sessions will be interactive, and the psychotherapist/meditation instructor will respond to your needs and preferences. | Behavioural | Spiritual Care or Psychotherapy/Meditation with SoC and Palliative Measures, plus Chemotherapy |
Primary outcome
To determine the overall survival (OS) of patients with non-curative malignancies
Time frame: From start of intervention till the date of death, up to 30 days after completing intervention
To determine the overall survival (OS) of patients with non-curative malignancies who receive chaplain-provided spiritual care or psychotherapy/ meditation in addition to SOC and palliative measures, plus chemotherapy if recommended.
11 secondary outcomes
Patient-reported quality of life assessed by the FACT-G questionnaire.
Time frame: Assessed at baseline and after interventions are completed, up to 24 weeks
Patient-reported quality of life assessed by the DASS-42 questionnaire.
Time frame: Assessed at baseline and after interventions are completed, up to 24 weeks
Patient-reported quality of life assessed by the AAQ questionnaire.
Time frame: Assessed at baseline and after interventions are completed, up to 24 weeks
Patient-reported quality of life assessed by the ACE questionnaire.
Time frame: Assessed at baseline and after interventions are completed, up to 24 weeks
Patient-reported quality of life assessed by the FACIT-Sp-Ex questionnaire.
Time frame: Assessed at baseline and after interventions are completed, up to 24 weeks
Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section A - Burnout.
Time frame: From initial assessment until final assessments are completed, every 6 months, up to 60 months
Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section B - Depersonalization.
Time frame: From initial assessment until final assessments are completed, every 6 months, up to 60 months
Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section C - Personal Achievement.
Time frame: From initial assessment until final assessments are completed, every 6 months, up to 60 months
Self-reported caretaker/physician burnout as assessed by the PROMIS questionnaire.
Time frame: From initial assessment until final assessments are completed, every 6 months, up to 60 months
Self-reported caretaker/physician burnout as assessed by the PFI questionnaire - Professional Fulfillment.
Time frame: From initial assessment until final assessments are completed, every 6 months, up to 60 months
Self-reported caretaker/physician burnout as assessed by the PFI questionnaire - Burnout.
Time frame: From initial assessment until final assessments are completed, every 6 months, up to 60 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 18 Dec 2025.
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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.
Hanh Mai, DO principal investigator
Houston Methodist Neal Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chaplain-Provided Spiritual Care and Psychotherapy and Meditation Intervention in people with Cancer, run by The Methodist Hospital Research Institute at 1 site 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 6 inclusion and 4 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hanh Mai, DO (713-441-2814, hmai2@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the overall survival (OS) of patients with non-curative malignancies (time frame: From start of intervention till the date of death, up to 30 days after completing intervention). 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 18 Dec 2025.