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Mindfulness Based Stress Reduction Intervention (MBRE) for Breast Cancer

N/A
Waitlist Available
Led By Cobi J. Heijnen, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

The goal of this study is to explore the effects of a Mindfulness Based Couples Intervention on relationship satisfaction with quality of life and immune system function among breast cancer survivors and their partners.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of Mindfulness Based Couples Therapy Intervention Among Breast Cancer Survivors and Their Partners (intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness Based Stress Reduction Intervention (MBRE)Experimental Treatment6 Interventions
Participant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts. Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.
Group II: Standard of CareActive Control6 Interventions
Participants receive self-help materials that have been previously developed by MD Anderson's Office of Public Education, the American Cancer Society, and the National Cancer Institute. Pain assessment administered at baseline and at follow up visit. Questionnaires completed at baseline and at follow up visit. Neurocognitive tests administered at baseline and at follow up visit. Cortisol testing performed after baseline visit and at follow up visit. Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330
Mindfulness-Based Relationship Enhancement (MBRE)
2015
N/A
~30
Pain Assessment
2015
Completed Phase 4
~370
Neurocognitive Tests
2015
N/A
~30
Cortisol Tests
2015
N/A
~30
Interviews
2017
N/A
~3890

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,452 Total Patients Enrolled
147 Trials studying Breast Cancer
63,262 Patients Enrolled for Breast Cancer
Cobi J. Heijnen, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
62 Total Patients Enrolled
Robert Dantzer, PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Mindfulness Based Couples Therapy
2015. "Mindfulness Based Couples Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02349217.
~2 spots leftby Apr 2025
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