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

NCT07290491 | Recruiting Phase 3 DMC

• 1 other identifier: PRO00037917 (HMCC-BR23-001)
• Study Type: interventional
• Target: 854
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Assessed at baseline and after interventions are completed, up to 24 weeks

• Patient-reported quality of life assessed by the DASS-42 questionnaire.

  Assessed at baseline and after interventions are completed, up to 24 weeks

• Patient-reported quality of life assessed by the AAQ questionnaire.

  Assessed at baseline and after interventions are completed, up to 24 weeks

• Patient-reported quality of life assessed by the ACE questionnaire.

  Assessed at baseline and after interventions are completed, up to 24 weeks

• Patient-reported quality of life assessed by the FACIT-Sp-Ex questionnaire.

  Assessed at baseline and after interventions are completed, up to 24 weeks

Other Outcomes (1)

• Measurement of circulating suppressor and effector immunocyte profiles; intracellular cytokines, enzymes and transcription factors

  From pre-intervention assessments until post-intervention assessments are completed, every 4 weeks, up to 24 weeks

Study Arms (2)

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.

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.

Interventions

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.

Spiritual Care or Psychotherapy/Meditation with SoC and Palliative Measures, plus Chemotherapy

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.

Spiritual Care or Psychotherapy/Meditation with SoC and Palliative Measures, plus Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Neal Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Hanh Mai, DO

  Houston Methodist Neal Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanh Mai, DO

CONTACT

713-441-2814; hmai2@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematologist-Oncologist

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: December 18, 2025
• Study Start: June 19, 2024
• Primary Completion (Estimated): May 10, 2029
• Study Completion (Estimated): May 10, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)