Clinical Trial Details

Primary Objective:

• To determine if CBCT can reduce distress for survivors compared to an attention control (Health Education; HE) when delivered by Zoom to both survivors and caregivers as a dyad (i.e., CBCT for dyads; CBCT-D). We will also test whether instructing survivors and caregivers together in CBCT (CBCT-D) reduces distress more than when survivors receive CBCT instruction by themselves, without caregivers (i.e., CBCT for survivors; CBCT-S). The following specific aims address these questions:
  Aim 1: Determine if survivors and caregivers exhibit less depression and anxiety (primary outcomes) when survivors receive online CBCT along with their informal caregiver (CBCT-D), compared to when survivors receive online CBCT alone (CBCT-S) or when survivors and informal caregivers 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. 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 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.
   The proposed research will provide important evidence regarding the efficacy of an online, synchronous dyadic CBCT intervention that leverages social connection with informal caregivers. This research will fill an important gap in evidence for interventions that can reduce distress, an NCI priority for the growing numbers of survivors and caregivers.