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

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT07290491
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 19, 2024
Status verified
Dec 2025
Primary completion
May 10, 2029
Completion
May 10, 2030

Study Design

Enrollment
854 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Neal Cancer CenterHoustonTexas77030
Hanh Mai, MD

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By research site
Houston Methodist Neal Cancer Center· Houston, TX

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