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

Breast Cancer Female Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676255
• Other study ID #: STUDY00001225
• Secondary ID: R01CA264047
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2023
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: University of Arizona
• Contact: Tausif Chowdhury
• Phone: 520-621-8809
• Email: tausifbhai[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 452
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Psychological Distress

Intervention

Behavioral:
• 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
• 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
• 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.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline depression to 8 weeks after the start of intervention
Primary	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.	Change from baseline anxiety to 8 weeks after the start of intervention
Secondary	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.	Change from baseline depression to 12 weeks after the start of intervention
Secondary	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.	Change from baseline anxiety to 12 weeks after the start of intervention
Secondary	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.	Change from baseline depression to 32 weeks after the start of intervention
Secondary	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.	Change from baseline anxiety to 32 weeks after the start of intervention