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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

854

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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

The Methodist Hospital Research Institute

Investigators

  • 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)

June 19, 2024

Primary Completion (Estimated)

May 10, 2029

Study Completion (Estimated)

May 10, 2030

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Cancer

Clinical Trials on Chaplain-Provided Spiritual Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe