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

Official title

Impact on Survival of Chaplain Provided Spiritual Care or Psychotherapy Combined With Palliative Care Versus Palliative Care Alone in Patients With Non-Curative Malignancies

Overview

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

• Behavioral 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 stress
• Behavioral 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

Primary outcome measures

• 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]

Secondary outcome measures (11)

• Patient-reported quality of life assessed by the FACT-G questionnaire. [Time frame: Assessed at baseline and after interventions are completed, up to 24 weeks]
• Patient-reported quality of life assessed by the DASS-42 questionnaire. [Time frame: Assessed at baseline and after interventions are completed, up to 24 weeks]
• Patient-reported quality of life assessed by the AAQ questionnaire. [Time frame: Assessed at baseline and after interventions are completed, up to 24 weeks]
• Patient-reported quality of life assessed by the ACE questionnaire. [Time frame: Assessed at baseline and after interventions are completed, up to 24 weeks]
• Patient-reported quality of life assessed by the FACIT-Sp-Ex questionnaire. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: From initial assessment until final assessments are completed, every 6 months, up to 60 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Houston Methodist Neal Cancer Center — Houston

Identifiers

NCT: NCT07290491 · PRO00037917 (HMCC-BR23-001)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗