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Meditation for Psychological Distress in Breast Cancer Survivors

Phase 2

Recruiting

Led By Thaddeus Pace, PhD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of breast cancer

Biological sex: woman

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline anxiety to 32 weeks after the start of intervention

Awards & highlights

Study Summary

This trial will research using meditation to reduce depression & anxiety in 70% of breast cancer survivors & their informal caregivers.

Who is the study for?

This trial is for English-speaking women who have finished their main breast cancer treatments (except hormonal therapies or trastuzumab) 3-5 years ago and are experiencing depression or anxiety. They must have a supportive partner to join them in the study. Women with regular meditation experience in the last 4 years or living in nursing homes cannot participate.Check my eligibility

What is being tested?

The SUPORT Project tests an online compassion meditation program called CBCT, designed to reduce depression and anxiety among breast cancer survivors. It includes both survivors alone and with their partners, compared to a health education control group.See study design

What are the potential side effects?

Since this trial involves psychological interventions like meditation training and health education, there may be minimal physical side effects; however, participants might experience emotional discomfort as they explore personal feelings during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with breast cancer.

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I am a woman.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline depression to 32 weeks after the start of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline depression to 32 weeks after the start of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline depression to 32 weeks after the start of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in anxiety features

Change in depression features

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cognitively-Based Compassion Training for Survivors (CBCT-S)Experimental Treatment1 Intervention

CBCT-S is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-S will be administered to breast cancer survivors and will not including supportive partners. Module 1 (Week 1): Overview and Connecting to A Moment of Nurturance Module 2 (Week 2) Developing Stable and Clear Attention Module 3 (Week 3): Enhancing Self Awareness Module 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering Module 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering. Module 6(Week 6): Expanding our Circle of Concern Module 7 (Week 7): Deepening Gratitude and Tenderness Module 8 (Week 8): Harnessing the Power of Compassion

Group II: Cognitively-Based Compassion Training for Dyads (CBCT-D)Experimental Treatment1 Intervention

CBCT-D is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. CBCT-D will be administered to breast cancer survivors and supportive partners together. Module 1 (Week 1): Overview and Connecting to A Moment of Nurturance Module 2 (Week 2) Developing Stable and Clear Attention Module 3 (Week 3): Enhancing Self Awareness Module 4 (Week 4): Cultivating Self compassion Part 1: Accepting our Suffering Module 5 (Week 5): Self Compassion Part 2: Finding Meaning in Suffering. Module 6(Week 6): Expanding our Circle of Concern Module 7 (Week 7): Deepening Gratitude and Tenderness Module 8 (Week 8): Harnessing the Power of Compassion

Group III: Health EducationActive Control1 Intervention

HE focuses on topics relevant to health and cancer, but is also intended for individuals who are not cancer survivors themselves. HE will be administered to both breast cancer survivors and supportive partners together. Module I (Week 1): Cancer Advocacy. Module II (Week 2): Health Through the Lifespan. Module III (Week 3): Nutrition. Module III (Week 4): Nutrition. Module IV (Week 5): Physical Activity. Module V (Week 6): Sleep. Module VI (Week 7): Stress. Module VII (Week 8): Mental Health and Social Support.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

515 Previous Clinical Trials

148,262 Total Patients Enrolled

23 Trials studying Breast Cancer

2,564 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,925,989 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Thaddeus Pace, PhDPrincipal InvestigatorUniversity of Arizona

2 Previous Clinical Trials

135 Total Patients Enrolled

Media Library

Cognitively-Based Compassion Training for Dyads Clinical Trial Eligibility Overview. Trial Name: NCT05676255 — Phase 2

Breast Cancer Research Study Groups: Cognitively-Based Compassion Training for Survivors (CBCT-S), Cognitively-Based Compassion Training for Dyads (CBCT-D), Health Education

Breast Cancer Clinical Trial 2023: Cognitively-Based Compassion Training for Dyads Highlights & Side Effects. Trial Name: NCT05676255 — Phase 2

Cognitively-Based Compassion Training for Dyads 2023 Treatment Timeline for Medical Study. Trial Name: NCT05676255 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA endorsed Cognitively-Based Compassion Training for Survivors (CBCT-S) yet?

"Our team at Power has evaluated the safety of Cognitively-Based Compassion Training for Survivors (CBCT-S) as a 2, due to its being in Phase 2, which implies that there is some evidence attesting to its security but no data confirming efficacy."

Answered by AI

Are there any vacancies still available for participants in this clinical experiment?

"This research project, which debuted on February 1st 2023 and was most recently updated December 22nd 2022, is not presently accepting applicants. Nonetheless, there are currently 2,281 alternative clinical trials that have open recruitment for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project

Thaddeus Pace 2023. "The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05676255.