Spiritual Care or Psychotherapy Versus Palliative Care Alone in Patients With Non-Curative Malignancies (SPC)

December 4, 2025 updated by: Hanh Mai, The Methodist Hospital Research Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
854

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Neal Cancer Center
        • Contact:
          • Hanh Mai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Spiritual Care or Psychotherapy/Meditation with SoC and Palliative Measures, plus Chemotherapy
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.
Behavioral: Chaplain-Provided Spiritual Care

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.

Behavioral: Psychotherapy and Meditation Intervention

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.
No Intervention: Standard of Care and Palliative Measures, plus Chemotherapy
Patients will receive Standard of Care and palliative measures, plus chemotherapy if recommended over 24 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From start of intervention till the date of death, up to 30 days after completing intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
FACT-G (Functional Assessment of Cancer Therapy- General) Version 4. Score values range from 0 to 135. Higher score means better outcome.
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
DASS-42 (Depression, Anxiety and Stress Scale). Score values range from 0 to 126. Higher score means worse outcome.
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
AAQ (Acceptance and Action Questionnaire II). Score values range from 7 to 49. Higher score means worse outcome.
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
ACE (Adverse Childhood Experience). Values range from 0 if no, and 1 if yes to any question. Higher score means worse outcome.
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
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.
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
MBI (Maslach Burnout Inventory). Section A burnout score values range from 0 to 42. Higher score means worse outcome.
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
MBI (Maslach Burnout Inventory). Section B Depersonalization score values range from 0 to 42. Higher score means worse outcome.
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
MBI (Maslach Burnout Inventory). Section C Personal Achievement score values range from 0 to 48. Higher score means better outcome.
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
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.
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
PFI (Professional Fulfillment Index). Questions 1-6 sum values range from 0 to 24. A higher score means better outcome.
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
PFI (Professional Fulfillment Index). Questions 7-16 sum values range from 0 to 40. A higher score means worse outcome.
From initial assessment until final assessments are completed, every 6 months, up to 60 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measurement of circulating suppressor and effector immunocyte profiles; intracellular cytokines, enzymes and transcription factors
Time Frame: From pre-intervention assessments until post-intervention assessments are completed, every 4 weeks, up to 24 weeks
Measurement of circulating suppressor and effector immunocyte profiles; intracellular cytokines, enzymes and transcription factors; systemic levels of cytokines and other soluble immune mediators, in the two arms of the trial. Correlative descriptive analysis with these and other biomarkers will be explored.
From pre-intervention assessments until post-intervention assessments are completed, every 4 weeks, up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Methodist Hospital Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hanh Mai, DO, Houston Methodist Neal Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO00037917 (HMCC-BR23-001)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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