NCT07290491 Spiritual Care or Psychotherapy Versus Palliative Care Alone in Patients With Non-Curative Malignancies
| NCT ID | NCT07290491 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The Methodist Hospital Research Institute |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 854 participants |
| Start Date | 2024-06-19 |
| Primary Completion | 2029-05-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 854 participants in total. It began in 2024-06-19 with a primary completion date of 2029-05-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Hanh Mai, DO
PRINCIPAL INVESTIGATOR
Houston Methodist Neal Cancer Center
Frequently Asked Questions
Who can join the NCT07290491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07290491 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 854 participants.
Is NCT07290491 currently recruiting?
Yes, NCT07290491 is actively recruiting participants. Contact the research team at hmai2@houstonmethodist.org for enrollment information.
Where is the NCT07290491 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07290491 clinical trial?
NCT07290491 is sponsored by The Methodist Hospital Research Institute. The principal investigator is Hanh Mai, DO at Houston Methodist Neal Cancer Center. The trial plans to enroll 854 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.