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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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
  • University of Arizona

    Tucson, Arizona, 85721

    Jacquelyn Martin, 520-621-1930, UArizona-SUPORT@email.arizona.edu

    Recruiting

Other trials in United States

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.

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 groups in NCT05676255
Study groupRoleWhat they receive
Cognitively-Based Compassion Training for Survivors (CBCT-S)ExperimentalCBCT-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)ExperimentalCBCT-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 EducationActive comparatorHE 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted9 Jan 2023
  2. Study start20 Mar 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jacquelyn Martin (520-621-1930, UArizona-SUPORT@email.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depression features (time frame: Change from baseline depression to 8 weeks after the start of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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