Meditation for Psychological Distress in Breast Cancer Survivors

Overseen By Tausif Chowdhury

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Arizona

Must be taking: Hormonal therapies

Disqualifiers: Nursing home resident, meditation experience

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

452 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a meditation program called Cognitively-Based Compassion Training (CBCT) to reduce depression and anxiety in women who have survived breast cancer. Researchers are examining two types of CBCT: one for survivors only and another for both survivors and their supportive partners. The trial will also compare these methods to a health education program. Women who completed their main cancer treatments at least three months ago and have a supportive partner willing to participate might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to potentially impactful mental health solutions.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that participants can continue hormonal therapies or trastuzumab.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Cognitively-Based Compassion Training (CBCT) is generally safe for breast cancer survivors. Research indicates that participants handle CBCT well, with few reports of negative effects. Previous studies demonstrated that CBCT reduced stress and improved self-kindness without causing harm. These findings support the safety of CBCT for both individuals and pairs of participants, such as survivors and their supportive partners. Although the safety results are promising, consulting a healthcare provider before joining any trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Cognitively-Based Compassion Training (CBCT) because it offers a unique approach to managing psychological distress in breast cancer survivors. Unlike standard treatments, which often focus on medication and traditional psychotherapy, CBCT is derived from Tibetan Buddhist methods and emphasizes cultivating compassion and self-awareness. The study is exploring two formats: one for survivors alone and one for survivors and their supportive partners together. This dual approach not only aims to enhance individual well-being but also strengthens the support system, potentially leading to more holistic and long-lasting benefits.

What evidence suggests that this trial's treatments could be effective for reducing psychological distress in breast cancer survivors?

Research has shown that Cognitively-Based Compassion Training (CBCT) can reduce stress and improve emotional well-being in breast cancer survivors. In this trial, participants will join different treatment arms, including CBCT for Survivors (CBCT-S) and CBCT for Dyads (CBCT-D). Studies have found that CBCT lowers stress related to the fear of cancer returning and enhances self-kindness and overall self-compassion. Participants practicing CBCT experience less anxiety and better mood control. The program effectively reduces stress-related hormone levels and manages inflammation, benefiting mental health. Overall, CBCT is a promising method for addressing psychological distress in breast cancer survivors. ^{1 2 3 4 6}

Who Is on the Research Team?

Thaddeus Pace, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to speak and understand English

I finished my main cancer treatments 3-5 years ago, except for hormone or trastuzumab therapy.

Have a supportive partner (aka caregiver) who can participate with them

Exclusion Criteria

I have practiced meditation regularly for the last 4 years.

I live in a nursing home.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CBCT-S, CBCT-D, or Health Education over 8 weeks

8 weeks

8 sessions (virtual)

Follow-up

Participants are monitored for changes in depression and anxiety features

32 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitively-Based Compassion Training for Dyads
• Cognitively-Based Compassion Training for Survivors
• Health Education

Trial Overview 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.

How Is the Trial Designed?

Group I: Cognitively-Based Compassion Training for Survivors (CBCT-S) Experimental Treatment 1 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 Treatment 1 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 Education Active Control 1 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.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Cognitively-Based Compassion Training (CBCT) was effective in reducing stress related to fear of cancer recurrence and improving self-compassion among breast cancer survivors in a randomized trial with 56 participants.

The study showed high participant enrollment (77%) and attendance, indicating strong interest and engagement in the CBCT intervention, which suggests it could be a valuable support tool for improving psychological well-being in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitively-Based Compassion Training (CBCT®) in Breast Cancer Survivors: A Randomized Clinical Trial Study. Gonzalez-Hernandez, E., Romero, R., Campos, D., et al.[2022]

In a study of female breast cancer survivors, higher levels of self-compassion were linked to lower symptoms of anxiety and depression, suggesting that fostering self-compassion could be beneficial for mental health in this population.

The study found that self-kindness and mindfulness helped reduce anxiety and depression by decreasing worry and rumination, indicating that self-compassion may serve as an effective strategy for improving emotional well-being in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could worry and rumination mediate relationships between self-compassion and psychological distress in breast cancer survivors? Brown, SL., Hughes, M., Campbell, S., et al.[2020]

A 6-week mindfulness meditation intervention significantly reduced depressive symptoms and perceived stress in 71 younger women treated for breast cancer, highlighting its efficacy as a psychological support tool.

Self-kindness emerged as a key emotion regulation strategy that mediated these reductions in distress, suggesting that fostering self-kindness could be an important focus in interventions for psychological well-being in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in emotion regulation following mindfulness meditation: Effects on depressive symptoms and perceived stress in younger breast cancer survivors. Boyle, CC., Stanton, AL., Ganz, PA., et al.[2022]

Cognitively Based Compassion Training (CBCT®) significantly increased self-compassion and reduced perceived stress among participants, with a notable improvement in emotional well-being measured over three time points in a study involving 65 individuals.

The training not only enhanced individual emotional health but also fostered greater community engagement, suggesting that CBCT® can be an effective intervention for promoting social well-being in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Cognitively Based Compassion Training in the outskirts: A mixed study. Kolchraiber, FC., Tanaka, LH., Negi, LT., et al.[2023]

The web-based self-compassion writing activity (MyCB) significantly increased state self-compassion and positive affect in breast cancer survivors compared to an expressive writing control, indicating its potential effectiveness in improving psychological outcomes.

Adding a meditation component (MyCB + M) further enhanced benefits, leading to greater increases in trait self-compassion and reductions in anxiety, suggesting that combining these interventions may optimize support for body image distress in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and pilot study of a brief self-compassion intervention addressing body image distress in breast cancer survivors. Mifsud, A., Pehlivan, MJ., Fam, P., et al.[2022]

The study involving 33 breast cancer survivors indicated that the meditation-based program, Cognitively-Based Compassion Training (CBCT), was feasible and well-received, with high participant satisfaction and attendance rates.

Participants in the CBCT group showed significant improvements in depression, intrusive thoughts, and perceived stress compared to the waitlist control group, suggesting potential psychological benefits for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Cognitively-Based Compassion Training (CBCT) for breast cancer survivors: a randomized, wait list controlled pilot study. Dodds, SE., Pace, TW., Bell, ML., et al.[2019]

This pilot trial is investigating the acceptability and preliminary efficacy of Cognitively-Based Compassion Training (CBCT) for improving health-related quality of life (HRQOL) in cancer survivors and their caregivers, with 40 dyads participating in an 8-week intervention.

CBCT aims to enhance self-compassion and empathy, potentially addressing depressive symptoms and other HRQOL domains, while also measuring biomarkers of inflammation and cortisol levels to assess overall wellness and healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial. Pace, TWW., Dodds, SE., Sikorskii, A., et al.[2020]

A short-term online version of Compassionate Mind Training (CMT) significantly increased compassion levels in both Sri Lankan and UK participants, demonstrating its effectiveness across cultures.

The study, which included 211 participants in total, showed that the benefits of CMT in reducing distress and enhancing well-being were maintained even two weeks after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Cross-cultural Applicability of a Brief Compassionate Mind Training: a Study Comparing Sri Lankan and UK People. Kariyawasam, L., Ononaiye, M., Irons, C., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29681185/

Cognitively-Based Compassion Training (CBCT®) in ... CBCT was effective in diminishing stress caused by FCR, fostering self-kindness and common humanity, and increasing overall self-compassion scores.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03305952

Cognitively-Based Compassion Training for Breast Cancer ... A Systematic review has shown positive results as an effective coping strategy that diminishes anxiety, stress, fatigue, general mood, sleep disturbances, and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6142100/

Cognitively-Based Compassion Training (CBCT®) in Breast ... Our findings suggest that an 8-week CBCT protocol is efficacious in reducing psychological stress related to FCR and increasing self-kindness, ...

4. withpower.com withpower.com/trial/meditation-for-psychological-distress-in-breast-cancer-survivors-281c2

Meditation for Psychological Distress in Breast Cancer ... Cognitively-Based Compassion Training (CBCT) was effective in reducing stress related to fear of cancer recurrence and improving self-compassion among breast ...

5. omicsdi.org omicsdi.org/dataset/biostudies-literature/S-EPMC6142100

Cognitively-Based Compassion Training (CBCT<sup>® ... To study the efficacy of the Cognitively-Based Compassion Training (CBCT) protocol in a BC survivor sample on quality of life, psychological well-being, fear of ...

6. cancercenter.arizona.edu cancercenter.arizona.edu/biblio/feasibility-cognitively-based-compassion-training-cbct-breast-cancer-survivors-randomized

Feasibility of Cognitively-Based Compassion Training (CBCT ... PURPOSE: This study assessed the feasibility of a meditation-based program called Cognitively-Based Compassion Training (CBCT) with breast cancer survivors.