Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07290491

Spiritual Care or Psychotherapy 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Houston Methodist Neal Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Hanh Mai, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chaplain-Provided Spiritual Care

Behavioral

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 Intervention

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanh Mai, DO

CONTACT

[email protected]

713-441-2814

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study 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

Acronym: SPC

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.