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

NCT06409065 | Recruiting

• 2 other identifiers: 2023-0450NCI-2024-03804
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Depressive Symptoms

  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.

Study Arms (3)

Attention Control

EXPERIMENTAL

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

Behavioral Intervention (FFM Program)

EXPERIMENTAL

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

Usual Care

EXPERIMENTAL

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

Behavioral: Meditation Program

Interventions

Meditation Program BEHAVIORAL

Meditation and discussion sessions will be audio recorded

Also known as: Discussion Program

Attention Control; Behavioral Intervention (FFM Program); Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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).
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kathrin Milbury, MD,PHD

  MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrin Milbury, MD,PHD

CONTACT

(713) 745-2868; kmilbury@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: January 9, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)