Recruiting
Phase 2

Observational Study

Sponsor:

University of Arizona

Code:

NCT05676255

Conditions

Breast Cancer Female

Psychological Distress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cognitively-Based Compassion Training for Survivors

Cognitively-Based Compassion Training for Dyads

Health Education

Study Details

Brief summary:

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).

Conditions

Breast Cancer Female

Psychological Distress

Study ID

NCT05676255

Start date

Mar 20, 2023

Status verified date

Jul, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Breast cancer survivors:

Inclusion Criteria:

  • biological sex: woman
  • able to speak and understand English
  • have a diagnosis of a breast cancer
  • have completed primary curative cancer treatments (i.e., surgery, radiation, chemotherapy) except for hormonal therapies (e.g., aromatase inhibitors) or trastuzumab a minimum of 3 months and a maximum of 5 years before starting CBCT or the control
  • have a supportive partner (aka caregiver) who can participate with them

Exclusion Criteria:

  • nursing home resident
  • have ongoing (1 or more meditation sessions per week) or past regular meditation experience in the last 4 years (i.e., more than two meditation sessions \[completed or attempted\] per year, either with a group or individually, to be evaluated by the Principal Investigator)

Supportive partners (aka informal caregivers)

Inclusion Criteria:

  • named by the survivor
  • live in the same household as the survivor
  • able to speak and understand English

Exclusion Criteria:

  • have ongoing (1 or more meditation sessions per week) or past regular meditation experience in the last 4 years (i.e., more than two meditation sessions \[completed or attempted\] per year, either with a group or individually, to be evaluated by the Principal Investigator)

Study Design

Enrollment

452 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Cognitively-Based Compassion Training for Survivors (CBCT-S)

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

experimental: Cognitively-Based Compassion Training for Dyads (CBCT-D)

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

active comparator: Health Education

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.

Interventions

Cognitively-Based Compassion Training for Survivors

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

Cognitively-Based Compassion Training for Dyads

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

Health Education

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.

Primary outcome measure

  • Change in depression features [ Time Frame: Change from baseline depression to 8 weeks after the start of intervention ]
  • Change in anxiety features [ Time Frame: Change from baseline anxiety to 8 weeks after the start of intervention ]

Central Contacts and Locations

Central contacts

Tausif Chowdhury

520-621-8809tausifbhai@arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Tausif Chowdhury

520-621-8809tausifbhai@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Jul 30, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2025-07-30.