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

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

Overview

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).

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.

Interventions

• 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
• Behavioral 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):
• Behavioral 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 H

Primary outcome measures

• Change in depression features [Time frame: Change from baseline depression to 8 weeks after the start of intervention]
• Change in anxiety features [Time frame: Change from baseline anxiety to 8 weeks after the start of intervention]

Secondary outcome measures (4)

• Change in depression features [Time frame: Change from baseline depression to 12 weeks after the start of intervention]
• Change in anxiety features [Time frame: Change from baseline anxiety to 12 weeks after the start of intervention]
• Change in depression features [Time frame: Change from baseline depression to 32 weeks after the start of intervention]
• Change in anxiety features [Time frame: Change from baseline anxiety to 32 weeks after the start of intervention]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Arizona — Tucson

Identifiers

NCT: NCT05676255 · STUDY00001225 · R01CA264047

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗