NCT05676255 The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project
| NCT ID | NCT05676255 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Arizona |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 452 participants |
| Start Date | 2023-03-20 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 452 participants in total. It began in 2023-03-20 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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)
Contact & Investigator
Thaddeus Pace, PhD
PRINCIPAL INVESTIGATOR
University of Arizona
Frequently Asked Questions
Who can join the NCT05676255 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05676255 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05676255 currently recruiting?
Yes, NCT05676255 is actively recruiting participants. Contact the research team at tausifbhai@arizona.edu for enrollment information.
Where is the NCT05676255 trial being conducted?
This trial is being conducted at Tucson, United States.
Who is sponsoring the NCT05676255 clinical trial?
NCT05676255 is sponsored by University of Arizona. The principal investigator is Thaddeus Pace, PhD at University of Arizona. The trial plans to enroll 452 participants.
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