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

Trial Summary

What is the purpose of this trial?

Many breast cancer survivors (estimated 70% in some studies) experience clinically significant depression and/or anxiety in the months and years after finishing cancer treatments. This research will build on the rigor of prior research to reduce breast cancer survivor depression and anxiety with a compassion meditation intervention called CBCT (Cognitively-Based Compassion Training) for online synchronous delivery that is also inclusive of informal caregivers (i.e., adult family members who live with and typically provide half the care for survivors, aka supportive partners).

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.

What data supports the effectiveness of the treatment Cognitively-Based Compassion Training for Dyads in breast cancer survivors?

Research suggests that Cognitively-Based Compassion Training (CBCT) can improve psychological well-being and reduce distress in breast cancer survivors, as well as in other populations. Studies have shown that CBCT may help reduce depressive symptoms and anxiety, and improve overall quality of life. ^{1 2 3 4 5}

Is Cognitively-Based Compassion Training (CBCT) safe for breast cancer survivors?

The studies on Cognitively-Based Compassion Training (CBCT) for breast cancer survivors suggest that it is generally safe, as they focus on its feasibility and participant satisfaction without reporting any significant safety concerns. ^{1 2 3 4 5}

How is Cognitively-Based Compassion Training (CBCT) different from other treatments for psychological distress in breast cancer survivors?

Cognitively-Based Compassion Training (CBCT) is unique because it focuses on enhancing self-compassion and reducing stress through meditation, which can help lower anxiety and depression by addressing worry and rumination. Unlike traditional treatments, CBCT specifically targets emotional regulation and self-kindness, offering a novel approach to improving psychological well-being in breast cancer survivors. ^{2 3 6 7 8}

Research Team

Thaddeus Pace, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitively-Based Compassion Training (CBCT®) in Breast Cancer Survivors: A Randomized Clinical Trial Study. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Feasibility of Cognitively-Based Compassion Training (CBCT) for breast cancer survivors: a randomized, wait list controlled pilot study. [2019]

4. Brazil pubmed.ncbi.nlm.nih.gov

Effects of Cognitively Based Compassion Training in the outskirts: A mixed study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Exploring the Cross-cultural Applicability of a Brief Compassionate Mind Training: a Study Comparing Sri Lankan and UK People. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Improvements in emotion regulation following mindfulness meditation: Effects on depressive symptoms and perceived stress in younger breast cancer survivors. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Could worry and rumination mediate relationships between self-compassion and psychological distress in breast cancer survivors? [2020]

8. England pubmed.ncbi.nlm.nih.gov

Feasibility and pilot study of a brief self-compassion intervention addressing body image distress in breast cancer survivors. [2022]