Cancer
Conditions
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.
Interventions
BEHAVIORALChaplain-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.
BEHAVIORALPsychotherapy 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.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the overall survival (OS) of patients with non-curative malignancies | From start of intervention till the date of death, up to 30 days after completing intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported quality of life assessed by the FACT-G questionnaire. | Assessed at baseline and after interventions are completed, up to 24 weeks | FACT-G (Functional Assessment of Cancer Therapy- General) Version 4. Score values range from 0 to 135. Higher score means better outcome. |
| Patient-reported quality of life assessed by the DASS-42 questionnaire. | Assessed at baseline and after interventions are completed, up to 24 weeks | DASS-42 (Depression, Anxiety and Stress Scale). Score values range from 0 to 126. Higher score means worse outcome. |
| Patient-reported quality of life assessed by the AAQ questionnaire. | Assessed at baseline and after interventions are completed, up to 24 weeks | AAQ (Acceptance and Action Questionnaire II). Score values range from 7 to 49. Higher score means worse outcome. |
| Patient-reported quality of life assessed by the ACE questionnaire. | Assessed at baseline and after interventions are completed, up to 24 weeks | ACE (Adverse Childhood Experience). Values range from 0 if no, and 1 if yes to any question. Higher score means worse outcome. |
| Patient-reported quality of life assessed by the FACIT-Sp-Ex questionnaire. | Assessed at baseline and after interventions are completed, up to 24 weeks | 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. |
| Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section B - Depersonalization. | From initial assessment until final assessments are completed, every 6 months, up to 60 months | MBI (Maslach Burnout Inventory). Section B Depersonalization score values range from 0 to 42. Higher score means worse outcome. |
| Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section C - Personal Achievement. | From initial assessment until final assessments are completed, every 6 months, up to 60 months | MBI (Maslach Burnout Inventory). Section C Personal Achievement score values range from 0 to 48. Higher score means better outcome. |
| Self-reported caretaker/physician burnout as assessed by the PROMIS questionnaire. | From initial assessment until final assessments are completed, every 6 months, up to 60 months | 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. |
| Self-reported caretaker/physician burnout as assessed by the PFI questionnaire - Professional Fulfillment. | From initial assessment until final assessments are completed, every 6 months, up to 60 months | PFI (Professional Fulfillment Index). Questions 1-6 sum values range from 0 to 24. A higher score means better outcome. |
| Self-reported caretaker/physician burnout as assessed by the PFI questionnaire - Burnout. | From initial assessment until final assessments are completed, every 6 months, up to 60 months | PFI (Professional Fulfillment Index). Questions 7-16 sum values range from 0 to 40. A higher score means worse outcome. |
| Self-reported caretaker/physician burnout as assessed by the MBI questionnaire - Section A - Burnout. | From initial assessment until final assessments are completed, every 6 months, up to 60 months | MBI (Maslach Burnout Inventory). Section A burnout score values range from 0 to 42. Higher score means worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Contacts
Primary ContactHanh Mai, DO
Outcome results
None listed