Spiritual Care or Psychotherapy Versus Palliative Care Alone in Patients With Non-Curative Malignancies
NCT ID: NCT07290491
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
854 participants
INTERVENTIONAL
2024-06-19
2030-05-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
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.
Standard of Care and Palliative Measures, plus Chemotherapy
Patients will receive Standard of Care and palliative measures, plus chemotherapy if recommended over 24 weeks.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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The Methodist Hospital Research Institute
OTHER
Responsible Party
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Hanh Mai
Hematologist-Oncologist
Principal Investigators
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Hanh Mai, DO
Role: PRINCIPAL_INVESTIGATOR
Houston Methodist Neal Cancer Center
Locations
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Houston Methodist Neal Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Hanh Mai, MD
Role: primary
Other Identifiers
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PRO00037917 (HMCC-BR23-001)
Identifier Type: -
Identifier Source: org_study_id