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

NCT ID: NCT06409065

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2028-08-31

Brief Summary

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.

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Meditation Program

Intervention Type: BEHAVIORAL

Meditation and discussion sessions will be audio recorded

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.

Group Type: EXPERIMENTAL

Meditation Program

Intervention Type: BEHAVIORAL

Meditation and discussion sessions will be audio recorded

Usual Care

All participants will receive cancer treatment per usual care (UC).

Group Type: EXPERIMENTAL

Meditation Program

Intervention Type: BEHAVIORAL

Meditation and discussion sessions will be audio recorded

Interventions

Meditation Program

Meditation and discussion sessions will be audio recorded

Intervention Type: BEHAVIORAL

Other Intervention Names

Discussion Program

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathrin Milbury, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

MD Anderson

Locations

MD Anderson

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kathrin Milbury, MD,PHD

Role: CONTACT

kmilbury@mdanderson.org

(713) 745-2868

Facility Contacts

Kathrin Milbury, MD,PHD

Role: primary

kmilbury@mdanderson.org

713-745-2868

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2024-03804

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0450

Identifier Type: -

Identifier Source: org_study_id