The Breast Cancer Survivors and Partners Online Research Together (SUPORT) Project
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
named by the survivor
live in the same household as the survivor
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitively-Based Compassion Training for Survivors
BehavioralCBCT-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
BehavioralCBCT-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
BehavioralHE 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.
Treatment groups
452 Participants
are divided into 3 treatment groupsGroup A: Cognitively-Based Compassion Training for Survivors (CBCT-S)Experimental treatment 1 intervention
Group B: Cognitively-Based Compassion Training for Dyads (CBCT-D)Experimental treatment 1 intervention
Group C: Health EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Change from baseline depression to 8 weeks after the start of intervention2
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.
Time frame
Change from baseline anxiety to 8 weeks after the start of interventionSecondary outcomes
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.
Time frame
Change from baseline depression to 12 weeks after the start of intervention2
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.
Time frame
Change from baseline anxiety to 12 weeks after the start of intervention3
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.
Time frame
Change from baseline depression to 32 weeks after the start of intervention4
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.
Time frame
Change from baseline anxiety to 32 weeks after the start of interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arizona
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov