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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported quality of life assessed by the FACT-G questionnaire. | FACT-G (Functional Assessment of Cancer Therapy- General) Version 4. Score values range from 0 to 135. Higher score means better outcome. | Assessed at baseline and after interventions are completed, up to 24 weeks |
| Patient-reported quality of life assessed by the DASS-42 questionnaire. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of circulating suppressor and effector immunocyte profiles; intracellular cytokines, enzymes and transcription factors | 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. |
Inclusion Criteria:
Patients are eligible to be included in the trial only if all of the following criteria apply
Exclusion Criteria:
Patients are excluded from the trial if any of the following criteria apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanh Mai, DO | Contact | 713-441-2814 | hmai2@houstonmethodist.org |
| Name | Affiliation | Role |
|---|---|---|
| Hanh Mai, DO | Houston Methodist Neal Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Neal Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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| 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. |
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DASS-42 (Depression, Anxiety and Stress Scale). Score values range from 0 to 126. Higher score means worse outcome. |
| Assessed at baseline and after interventions are completed, up to 24 weeks |
| Patient-reported quality of life assessed by the AAQ questionnaire. | AAQ (Acceptance and Action Questionnaire II). Score values range from 7 to 49. Higher score means worse outcome. | Assessed at baseline and after interventions are completed, up to 24 weeks |
| Patient-reported quality of life assessed by the ACE questionnaire. | ACE (Adverse Childhood Experience). Values range from 0 if no, and 1 if yes to any question. Higher score means worse outcome. | Assessed at baseline and after interventions are completed, up to 24 weeks |
| Patient-reported quality of life assessed by the FACIT-Sp-Ex questionnaire. | 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. | Assessed at baseline and after interventions are completed, up to 24 weeks |
| Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section A - Burnout. | MBI (Maslach Burnout Inventory). Section A burnout score values range from 0 to 42. Higher score means worse outcome. | From initial assessment until final assessments are completed, every 6 months, up to 60 months |
| Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section B - Depersonalization. | MBI (Maslach Burnout Inventory). Section B Depersonalization score values range from 0 to 42. Higher score means worse outcome. | From initial assessment until final assessments are completed, every 6 months, up to 60 months |
| Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section C - Personal Achievement. | MBI (Maslach Burnout Inventory). Section C Personal Achievement score values range from 0 to 48. Higher score means better outcome. | From initial assessment until final assessments are completed, every 6 months, up to 60 months |
| Self-reported caretaker/physician burnout as assessed by the PROMIS questionnaire. | 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. | From initial assessment until final assessments are completed, every 6 months, up to 60 months |
| Self-reported caretaker/physician burnout as assessed by the PFI questionnaire - Professional Fulfillment. | PFI (Professional Fulfillment Index). Questions 1-6 sum values range from 0 to 24. A higher score means better outcome. | From initial assessment until final assessments are completed, every 6 months, up to 60 months |
| Self-reported caretaker/physician burnout as assessed by the PFI questionnaire - Burnout. | PFI (Professional Fulfillment Index). Questions 7-16 sum values range from 0 to 40. A higher score means worse outcome. | From initial assessment until final assessments are completed, every 6 months, up to 60 months |
| From pre-intervention assessments until post-intervention assessments are completed, every 4 weeks, up to 24 weeks |