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Behavioral Intervention

Meditation Program for Cancer Patients and Caregivers

N/A
Recruiting
Led By Kathrin Milbury, MD,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have an ECOG performance status of ≤2
Be diagnosed with a metastatic (stage IV) breast, thoracic, gastrointestinal, gynecological, or genitourinary cancer
Must not have
Children under the age of 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Summary

"This trial aims to understand how two different support programs can impact the mental health and quality of life of patients and their family caregivers."

Who is the study for?
This trial is for adults with stage IV breast, thoracic, gastrointestinal, gynecological, or genitourinary cancer who've had no disease progression for at least 3 months. They must have a caregiver willing to join the study and both should be able to understand English or Spanish. Participants need an ECOG performance status of ≤2 and a distress score ≥4.
What is being tested?
The study examines the impact of two different supportive care programs on psychological wellbeing and quality of life in patients with advanced cancer and their caregivers. It involves a meditation program designed to help manage psycho-spiritual aspects related to cancer.
What are the potential side effects?
Since this trial focuses on meditation as an intervention rather than medication, there are no typical drug side effects; however, participants may experience emotional discomfort when discussing personal issues during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform daily activities.
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I have been diagnosed with stage IV cancer in breast, lung, stomach, reproductive organs, or urinary system.
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I and my caregiver are both over 18 years old.
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My cancer has not worsened in the last 3 months according to CT scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depressive Symptoms

Trial Design

3Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
All participants will receive cancer treatment per usual care (UC).
Group II: Behavioral Intervention (FFM Program)Experimental Treatment1 Intervention
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 III: Attention ControlExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,375 Total Patients Enrolled
Kathrin Milbury, MD,PHDPrincipal InvestigatorMD Anderson
~267 spots leftby Jul 2028
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