Recruiting
Phase 3

Spiritual Care & Psychotherapy

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT07290491

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chaplain-Provided Spiritual Care

Psychotherapy and Meditation Intervention

Study Details

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

Study ID

NCT07290491

Start date

Jun 19, 2024

Status verified date

Dec, 2025

Completion date

May 10, 2030

Anticipated

Primary completion date

May 10, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

854 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

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 ]

Central Contacts and Locations

Central contacts

Hanh Mai, DO

713-441-2814hmai2@houstonmethodist.org

Locations

Houston Methodist Neal Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2025-12-18.