Psycho-Spiritual Management for Patients With Advanced Cancer and Their Family Caregivers

March 2, 2026 updated by: M.D. Anderson Cancer Center
The goal of this behavioral research study is to learn about the effects of two different supportive care programs on patients' and their family caregivers' psychological wellbeing and overall quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To enhance the accessibility and scalability for future research, both the interventions (FFM and AC) will be delivered via videoconferencing. To increase the generalizability of the findings, a multi-site enrollment recruitment strategy will be used to enroll a diverse (including underserved) patient population. The program will be delivered in both English and Spanish and a varied social economic population will be enrolled in the program.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be diagnosed with a metastatic (stage IV) breast, thoracic, gastrointestinal, gynecological, or genitourinary cancer
  • Be without disease progression for at least 3 months based on surveillance CT imaging
  • Have an ECOG performance status of ≤2
  • Have a family caregiver willing to participate

Both patient and caregiver must meet all the following criteria:

  • Be ≥18 years old
  • Be able to read and speak English or Spanish.
  • Be able to provide informed consent

Additionally, either the patient and/or caregiver must:

• Have a NCCN Distress Thermometer score of ≥4

Exclusion Criteria:

A patient who meets the following criteria will be excluded from participation in this study:

• Have cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist

3.3 Vulnerable Populations This study is designed for individuals who are at least 18 years of age, and there is no upper age limit. Children under the age of 18 will not be included. First and foremost, it is unlikely that a minor is diagnosed with a metastatic solid tumor. It is also unlikely that a minor serves as the primary family caregiver of a patient with cancer. Additionally, the intervention is designed for adults, and the assessment tools are not validated for minors. While pregnant caregivers (self-identified) are study eligible, we will also exclude pregnant patients (medical notes).

3.4 Recruitment/Screening Process Eligible study participants (i.e. cancer patients) will be identified using the electronic clinic appointment systems on their tumor characteristics (i.e. cancer type and stage) and date of birth (i.e. minimum 18 years old). Potential patients and caregivers will be approached during patients' appointment at an outpatient oncology appointment, screened for eligibility, and consented. Since this is a family-based intervention, it is possible that caregivers will not be present during the patients' clinic visits. If so, patients will be asked for permission to contact the caregiver via phone to obtain consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Attention Control
Participants will take part in a meditation program. As part of this program, participants will complete up to 4 meditation sessions with a trained counselor. Participants should attend each session together as a family. All sessions will be online by videoconference using Zoom.
Behavioral: Meditation Program
Meditation and discussion sessions will be audio recorded
Other Names:
  • Discussion Program
Experimental: Behavioral Intervention (FFM Program)
Participants will take part in a discussion program. Participants will be asked to complete 4 discussion sessions with a trained counselor over a course of a 4 week period. Participants should attend each session together as a family.
Behavioral: Meditation Program
Meditation and discussion sessions will be audio recorded
Other Names:
  • Discussion Program
Experimental: Usual Care
All participants will receive cancer treatment per usual care (UC).
Behavioral: Meditation Program
Meditation and discussion sessions will be audio recorded
Other Names:
  • Discussion Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptoms
Time Frame: Through study completion; an average of 1 year.
Participants will complete the Center for Epidemiologic Studies Depression Scale (CES-D), a 20-item self-report measure focusing on the affective component of depression, which is appropriate as patients may experience somatic symptoms due to treatment toxicities rather than depression.
Through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Kathrin Milbury, MD,PHD, MD Anderson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2024

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0450
  • NCI-2024-03804 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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