854 Participants Needed

Spiritual Care or Psychotherapy for Cancer

(SPC Trial)

HM
Overseen ByHanh Mai, DO
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: The Methodist Hospital Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding spiritual care or psychotherapy/meditation can improve survival in people with advanced cancer. Participants will receive either spiritual support from a chaplain or therapy sessions, along with standard treatments like chemotherapy, based on their doctor's recommendation. The trial seeks individuals with advanced cancer who have been told they might have a year or less to live and are willing to participate in regular sessions. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that spiritual care, such as support from hospital chaplains, is generally appreciated by patients. Many patients welcome this type of care, which can enhance their quality of life. By focusing on emotional and spiritual support, it typically avoids causing any physical side effects.

For psychotherapy and meditation, studies indicate they often reduce anxiety, stress, and depression in cancer patients. These methods have been linked to better pain management and improved quality of life. Reports suggest these treatments are safe, with no serious side effects found in the studies reviewed.

Both spiritual care from chaplains and psychotherapy/meditation have been shown to be safe and well-received by patients in past research.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine traditional cancer care with holistic approaches like spiritual care and psychotherapy/meditation. Unlike standard cancer treatments, which mainly focus on chemotherapy and palliative measures, these interventions aim to address the emotional and spiritual well-being of patients alongside their physical health. By incorporating chaplain-provided spiritual care or psychotherapy and meditation, this approach offers a more comprehensive treatment that could enhance patients' overall quality of life during their cancer journey.

What evidence suggests that this trial's treatments could be effective for cancer?

Research shows that spiritual care and practices like therapy and meditation can benefit people with cancer. In this trial, participants will receive either individual spiritual care from a chaplain or personal psychotherapy/meditation from a psychotherapist/meditation instructor, alongside standard care and palliative measures. Studies have found that patients supported by chaplains tend to have lower rates of dying in the hospital and are more likely to use hospice services, suggesting better end-of-life care. Meanwhile, mindfulness-based practices in therapy and meditation significantly reduce anxiety, depression, fatigue, and stress in cancer patients. Patients also report feeling better overall, having more social support, and finding more meaning in life. Overall, these treatments can improve the quality of life for people with cancer.16789

Who Is on the Research Team?

HM

Hanh Mai, DO

Principal Investigator

Houston Methodist Neal Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with advanced cancers that cannot be cured. They are eligible if they're already receiving standard-of-care treatments, which may include chemotherapy, and palliative care to manage symptoms and pain.

Inclusion Criteria

I am 18 years old or older.
My cancer has spread, and doctors expect I have a year or less to live.
I can care for myself but may not be able to do heavy physical work.
See 2 more

Exclusion Criteria

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
I do not have mobility issues that would prevent me from following the trial's requirements.
Confirmed positive pregnancy test in women of child bearing potential

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either spiritual care or psychotherapy/meditation in addition to standard-of-care and palliative measures, plus chemotherapy if recommended, for 24 sessions over 24 weeks

24 weeks
24 visits (in-person)

Follow-up

Participants are monitored for overall survival and quality of life assessments after treatment

4 weeks

Long-term Follow-up

Self-reported caretaker/physician burnout and other assessments are conducted every 6 months

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

  • Chaplain-Provided Spiritual Care
  • Psychotherapy and Meditation Intervention

Trial Overview

The study is testing whether adding spiritual care provided by a chaplain or psychotherapy combined with meditation to the usual palliative care improves survival rates in these patients compared to those who only receive standard palliative care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Spiritual Care or Psychotherapy/Meditation with SoC and Palliative Measures, plus ChemotherapyExperimental Treatment2 Interventions
Group II: Standard of Care and Palliative Measures, plus ChemotherapyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+

Citations

Interprofessional spiritual care in oncology: a literature review

Based on the aforementioned data, it is clear that spirituality plays a fundamental role in care of patients with cancer and may offer a positive impact on ...

Medical Outcomes of Oncology Inpatients With and Without ...

Patients who received spiritual care were older and sicker. Readmission rates within 30 days were greater in the spiritual care group (OR = 1.07 ...

a qualitative study of focus groups with cancer center chaplains

Eight of 13 chaplain respondents (61.5%) reported that they provided spiritual care exclusively and in a full-time capacity to a cancer center; ...

Evaluation of spiritual needs assessments in oncology ...

At our Cancer Center, we sought to ensure that palliative care (PC) inpatients received evidence-based spiritual care. Methods: Chaplaincy Care, Supportive Care ...

A national study of chaplaincy services and end-of-life outcomes

The analyses found significantly lower rates of hospital deaths (β = .04, p < .05) and higher rates of hospice enrollment (β = .06, p < .001) ...

How Chaplains Improve Hospital Outcomes and Patient ...

Hospitals that provided chaplaincy services had significantly lower rates of hospital deaths, even when controlling for various factors such as ...

Spiritual Care or Psychotherapy Versus Palliative ...

This phase III clinical trial will evaluate the impact on survival of adding chaplain-provided spiritual care or psychotherapy/meditation to ...

Provision of Spiritual Support to Patients With Advanced ...

Data suggest that provision of spiritual care by medical teams to terminally ill patients is associated with better patient quality of life (QoL), greater ...

An Analysis of Chaplains' Narrative Chart Notes Describing ...

Theme 6: patients were receptive to spiritual care, regardless of their belief systems. Thirty-two patients (36%) were receptive to a prayer or blessing offered ...