Caregivers-Patients Support Coping With Advanced-Cancer (CASA) Intervention

Caregivers-Patients Support Coping With Advanced-Cancer (CASA) Intervention

This pilot aims to prepare the PI to receive hands-on experience in implementation and dissemination and design and lead pilot studies in palliative care. The catchment area communities experience lower cancer health outcomes and are more likely to be diagnosed with advanced cancer when compared to other surrounding areas. The PI's catchment area experiences advanced cancer, and their caregivers are at an increased risk for unmet psychosocial needs; this pre-pilot will allow the PI to focus on this critical gap in equal healthcare. The research goal of this proposal is to refine and pre-pilot an intervention titled Caregivers Patients Support to Cope with Advanced Cancer (CASA), a five-session, 60-minute telehealth series for patient-caregiver dyads. The rationale for this project is that it will lay the groundwork for a Randomized Control Trial (RCT) testing the efficacy of CASA. It will also assess the implementation of an innovative method to deliver the CASA intervention. This study aims to use the collaborative intervention planning framework and ORBIT model to modify and assess the feasibility and preliminary effect of the CASA intervention. The overall impact of this study is to improve access to psychosocial interventions in the proposed catchment area.

The proposed study will follow a mixed-methods pilot study. The intervention trial will involve conducting an adapted Caregivers-Patients Support intervention to Cope with Advanced-Cancer (CASA) randomized clinical trial framed under the the collaborative intervention planning framework. The team will collect data for primary outcome (Spiritual Well-Being Scale) and secondary outcomes. The secondary outcomes include Hospital Anxiety and Depression Scale (HADS), Beck Hopelessness Scale (BHS), Functional Assessment of Cancer Therapy-General (FACT-G), Family Relationship Index, Holding Back subscale, Zarit Burden Interview (ZBI), and NCCN Distress Thermometer. All measures are available in Spanish and the team has used them in previous studies with Hispanic/Latinx patients and caregivers coping with advanced cancer. Highly innovative analyses exploring feasibility and preliminary effect. Definitions of feasibility will include: (1) ≥60% enrollment among approached participants, (2) ≥70% completion of baseline and T2 surveys; (3) ≥80% of participants in the intervention group agreeing with the item CASA was helpful to me; and (4) ≤20% of respondents in the intervention group agreeing with the item CASA placed a considerable burden on me. Preliminary effects evaluation will include: a linear mixed effect modeling and an intent-to-treat approach to analyze the results. The results of FACIT, FRI, HBS, HADS, BHS, DT, FACT-G, and ZB will be analyzed with a paired t-test, Wilcoxon signed ranks test, and McNemar. Linear mixed effect modeling is statistically appropriate because we will use one independent variable (CASA intervention) with more than two dependent/matched groups (patients-control, caregivers-control, patients-in-treatment, caregivers-in-treatment, patients-caregiver-control, and patients-caregivers-in-treatment). The primary outcome is pre- to post-intervention changes in spirituality (FACIT). Change scores have the advantage of clearly showing the direction of change. The linear mixed effects model analysis will include two primary fixed-effect covariates: 1) spirituality to provide some control over variability in participants baseline; and 2) treatment assignment (CASA vs. control group). The same approach will be used for the secondary outcomes (FACT-IT, HADS, BHS, DT, FACT-G, and ZB). Qualitative Analyses. Interviews will be digitally recorded with consent and analyzed thematically using a matrix. Each thematic matrix will contain data from the interviews pertaining to the theme in question, alongside participant information (demographics, changes in scores). The qualitative analysis will help explain the feasibility/acceptability. The team will implement minor refinements to enhance the relevance of the CASA intervention for the target population and context.

Inclusion Criteria:

• Cancer patients must be stage III and IV solid tumor patients who report distress >4 on the Distress Thermometer
• Caregivers. Identified caregivers by distressed patients.

Exclusion Criteria:

• diagnosed with a major disabling medical or psychiatric condition
• unable to understand the consent procedure, or (3) too ill to participate, all as reported by the participant and/or determined by the investigator's judgment.