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

Last updated: May 6, 2024
Sponsor: University of Arizona
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Cognitively-Based Compassion Training for Survivors

Cognitively-Based Compassion Training for Dyads

Health Education

Clinical Study ID

NCT05676255
STUDY00001225
R01CA264047
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion

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) ortrastuzumab a minimum of 3 months and a maximum of 5 years before starting CBCT or thecontrol
  • have a supportive partner (aka caregiver) who can participate with them

Exclusion

Exclusion Criteria:

  • nursing home resident
  • have ongoing (1 or more meditation sessions per week) or past regular meditationexperience in the last 4 years (i.e., more than two meditation sessions [completed orattempted] per year, either with a group or individually, to be evaluated by thePrincipal 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 meditationexperience in the last 4 years (i.e., more than two meditation sessions [completed orattempted] per year, either with a group or individually, to be evaluated by thePrincipal Investigator)

Study Design

Total Participants: 452
Treatment Group(s): 3
Primary Treatment: Cognitively-Based Compassion Training for Survivors
Phase: 2
Study Start date:
March 20, 2023
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • University of Arizona

    Tucson, Arizona 85721
    United States

    Active - Recruiting

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