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

NCT05676255 | Recruiting Phase 2 DMC

• 2 other identifiers: STUDY00001225R01CA264047
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in depression features

  The difference in the change in depression features between the intervention arms from before to 8 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.

  Change from baseline depression to 8 weeks after the start of intervention

• Change in anxiety features

  The difference in the change in anxiety features between the intervention arms from before to 8 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.

  Change from baseline anxiety to 8 weeks after the start of intervention

Secondary Outcomes (4)

• Change in depression features

  Change from baseline depression to 12 weeks after the start of intervention

• Change in anxiety features

  Change from baseline anxiety to 12 weeks after the start of intervention

• Change in depression features

  Change from baseline depression to 32 weeks after the start of intervention

• Change in anxiety features

  Change from baseline anxiety to 32 weeks after the start of intervention

Study Arms (3)

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

EXPERIMENTAL

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

Behavioral: Cognitively-Based Compassion Training for Survivors

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

EXPERIMENTAL

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

Behavioral: Cognitively-Based Compassion Training for Dyads

Health Education

ACTIVE COMPARATOR

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.

Behavioral: Health Education

Interventions

Cognitively-Based Compassion Training for Survivors BEHAVIORAL

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

Also known as: CBCT-S

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

Cognitively-Based Compassion Training for Dyads BEHAVIORAL

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

Also known as: CBCT-D

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

Health Education BEHAVIORAL

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.

Also known as: HE

Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

Study Officials

• Thaddeus Pace, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tausif Chowdhury

CONTACT

520-621-8809; tausifbhai@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be informed of their group assignment only after completion of the baseline (T1) assessment, and data collectors will be blinded to study group assignment for all future assessments. Participants will be asked to not discuss their group assignment with anyone other than the study coordinator. The PI and other investigators will be blinded to arm assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nursing, Psychiatry, and Psychology

Model Details: randomized clinical trial design

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: March 20, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)