Adding spiritual care or psychotherapy to palliative care for people with advanced cancer
Impact on Survival of Chaplain Provided Spiritual Care or Psychotherapy Combined With Palliative Care Versus Palliative Care Alone in Patients With Non-Curative Malignancies
This trial will see if adding chaplain-led spiritual care or psychotherapy with meditation to standard palliative care (and chemotherapy when recommended) helps people with advanced, non-curative cancer live longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 854 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07290491 on ClinicalTrials.gov |
What this trial studies
This phase III interventional trial will compare survival in patients with metastatic, non-curative malignancies who receive standard palliative care (and chemotherapy when recommended) versus those who also receive chaplain-provided spiritual care or psychotherapy with meditation. Participants must have histologically confirmed metastatic disease with an expected life expectancy of one year or less and an ECOG performance status of 0–3. Interventions are delivered alongside the palliative care services provided by the Houston Methodist Palliative Care Department. The study aims to determine whether adding structured spiritual or psychological support affects survival outcomes compared with palliative care alone.
Who should consider this trial
Good fit: Adults (18+) with histologically confirmed metastatic cancer and a life expectancy of one year or less, ECOG performance status 0–3, who can attend scheduled visits and provide informed consent are eligible.
Not a fit: Patients with curable disease, those with psychiatric or substance-abuse disorders that interfere with participation, significant mobility limitations, or confirmed pregnancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding spiritual care or psychotherapy could extend survival and improve emotional and spiritual well-being for people with advanced cancer.
How similar studies have performed: Smaller prior studies have shown spiritual care and psychotherapy can improve quality of life and psychological outcomes, but survival benefits remain largely unproven, so this larger phase III trial addresses that gap.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- Houston Methodist Neal Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Hanh Mai, DO — Houston Methodist Neal Cancer Center
- Study coordinator: Hanh Mai, DO
- Email: hmai2@houstonmethodist.org
- Phone: 713-441-2814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.