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

NCT ID: NCT05676255

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2027-06-30

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).

Detailed Description

The goal of this project is to determine if CBCT (Cognitively-Based Compassion Training) can reduce distress for survivors compared to an attention control (Health Education; HE) when delivered by Zoom to both survivors and caregivers/ supportive partners as a dyad (i.e., CBCT for dyads; CBCT-D). We will also test whether instructing survivors and caregivers/ supportive partners together in CBCT (CBCT-D) reduces distress more than when survivors receive CBCT instruction by themselves, without caregivers/ supportive partners (i.e., CBCT for survivors; CBCT-S). The following specific aims address these questions:

Aim 1: Determine if survivors and caregivers/ supportive partners exhibit less depression and anxiety (primary outcomes) when survivors receive online CBCT along with their informal caregiver// supportive partner (CBCT-D), compared to when survivors receive online CBCT alone (CBCT-S) or when survivors and informal caregivers// supportive partners receive online HE. We will recruit dyads (N=226) consisting of survivors (between 3 months and 5 years post treatments with curative intent, i.e., chemotherapy, radiation, surgery) and their caregivers/ supportive partners. H1: Survivors and caregivers randomized to CBCT-D will exhibit greater improvements in distress (i.e., depression, anxiety; primary outcomes in survivors) at months 2, 3, and 8 versus those randomized to CBCT-S or HE.

Aim 2: Test the extent to which reductions in survivor's depression and anxiety from online CBCT-D are mediated by social connection, dyadic function, and caregiver/ supportive partner distress. H2a: Survivor's social connection and dyadic function will mediate the effects of online CBCT-D versus HE on survivor's distress at months 2, 3 and 8. H2b: Caregiver's social connection, dyadic function, and distress will mediate the effects of CBCT-D versus CBCT-S or HE on survivor's distress.

Aim 3: Explore the effects of online CBCT-D versus CBCT-S and HE on survivor diurnal cortisol rhythm at months 2, 3 and 8, and the extent to which cortisol rhythm is a marker versus mediator of improvements in survivor's distress at month 2, 3, and 8.

Conditions

Breast Cancer Female; Psychological Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Cognitively-Based Compassion Training for Survivors

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Cognitively-Based Compassion Training for Dyads

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: 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.

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBCT-S; CBCT-D; HE

Eligibility Criteria

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

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

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)

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Thaddeus Pace

Associate Professor of Nursing, Psychiatry, and Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thaddeus Pace, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tausif Chowdhury

Role: CONTACT

tausifbhai@arizona.edu

520-621-8809

Facility Contacts

Tausif Chowdhury

Role: primary

tausifbhai@arizona.edu

520-621-8809

Other Identifiers

R01CA264047

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001225

Identifier Type: -

Identifier Source: org_study_id