Breast Cancer FemalePhase 2NCT05676255
The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project
A Phase 2 study testing Cognitively-Based Compassion Training for Survivors, Cognitively-Based Compassion Training for Dyads and Health Education in people with Breast Cancer Female and Psychological Distress, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female, Psychological Distress
- What is being tested?
- Cognitively-Based Compassion Training for Survivors, Cognitively-Based Compassion Training for Dyads and Health Education
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85721
Jacquelyn Martin, 520-621-1930, UArizona-SUPORT@email.arizona.edu
About this study
Official title: The SUPORT Project: Leveraging Social Connection by Including Informal Caregivers in an Internet Video Conference-based Compassion Meditation Intervention to Reduce Psychological Distress in Breast Cancer Survivors
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).
Read the 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
- Being tested
- Cognitively-Based Compassion Training for Survivors, Cognitively-Based Compassion Training for Dyads, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitively-Based Compassion Training for SurvivorsBehavioural
Also called 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
Cognitively-Based Compassion Training for DyadsBehavioural
Also called 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
Health EducationBehavioural
Also called HE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline anxiety to 8 weeks after the start of intervention
Secondary outcomes (4)
Change in depression features
The difference in the change in depression features between the intervention arms from before to 12 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.
Measured: Change from baseline depression to 12 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 12 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.
Measured: Change from baseline anxiety to 12 weeks after the start of intervention
Change in depression features
The difference in the change in depression features between the intervention arms from before to 32 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Depression - 8a.
Measured: Change from baseline depression to 32 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 32 weeks after start of the interventions will be measured with the Patient-Reported Outcomes Measurement Information System short form Anxiety - 8a.
Measured: Change from baseline anxiety to 32 weeks after the start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start20 Mar 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Thaddeus Pace, University of Arizona
- Investigators
- Thaddeus Pace, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676255
- Sponsor's protocol ID
- STUDY00001225
- Other IDs
- R01CA264047
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not applicable as of current version date