Decision support training for advanced cancer family caregivers: Study protocol for the CASCADE factorial trial.

BACKGROUND: Patients with advanced cancer face numerous decisions when diagnosed and often receive decision support from family caregivers. The CASCADE (CAre Supporters Coached to be Adept DEcision partners) factorial trial intervention aims to train caregivers in skills to provide effective decision support to patients and identify most effective intervention components. METHODS: This is a 2-site, single-blind, 24 factorial trial to test components of the CASCADE decision support training intervention for family caregivers of patients with newly-diagnosed advanced cancer delivered by specially-trained, telehealth, palliative care lay coaches over 24 weeks. Family caregivers (target N = 352) are randomly assigned to one of 16 combinations of four components with two levels each: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision support communication training (1 session vs. none); 3) Ottawa Decision Guide training (1 session vs. none) and 4) monthly follow-up (1 call vs. calls for 24 weeks). The primary outcome is patient-reported decisional conflict at 24 weeks. Secondary outcomes include patient distress, healthcare utilization, caregiver distress, and quality of life. Mediators and moderators (e.g., sociodemographics, decision self-efficacy, social support) will be explored between intervention components and outcomes. Results will be used to build two versions of CASCADE: one with only effective components (d ≥ 0.30) and another optimized for scalability and cost. DISCUSSION: This protocol describes the first factorial trial, informed by the multiphase optimization strategy, of a palliative care decision-support intervention for advanced cancer family caregivers and will address the field's need to identify effective components that support serious illness decision-making. TRIAL REGISTRATION: NCT04803604.

Systematic braiding of Smoke-Free Home SafeCare to address child maltreatment risk and secondhand smoke exposure: findings from a pilot study.

BACKGROUND: Exposure to secondhand tobacco smoke (SHS) and child maltreatment are preventable threats to child health. Few evidence-based interventions target both SHS and child maltreatment risk. The purpose of this paper is to describe the systematic braiding process of two evidence-based programs to address child SHS in the home and maltreatment perpetration risk, and present results from the formative work and pilot study. METHODS: The first 4 steps of the systematic braiding process were completed, including the following: (1) the identification of core elements of both programs, (2) the development of an initial draft of the braided curriculum (Smoke-Free Home SafeCare - SFH-SC), (3) an acceptability and feasibility pilot of SFH-SC with caregivers of young children who reported a smoker living in the home (N = 8), and (4) feedback collection on the braided curriculum from SafeCare Providers (N = 9). RESULTS: Experts identified common pedagogical and theoretical underpinnings for the two programs and braided Smoke-Free Homes: Some Things Are Better Outside into two SafeCare modules. Caregiver feedback from the pilot demonstrated that participants were engaged with SFH-SC and felt supported and comfortable discussing SHS intervention content with the SFH-SC Provider. Caregiver self-reports indicated a slight increase in smoke-free home rules from baseline to follow-up and a notable reduction in parent stress on the Parent Stress Index of 5.9 points (SD = 10.2). SafeCare Provider feedback following intensive review of the curriculum indicated high feasibility for SFH-SC delivery. CONCLUSIONS: Parent and Provider findings suggest SFH-SC is a viable intervention that has potential to reduce the public health impact of SHS and child maltreatment for at-risk families. PROTOCOL: The protocol for the pilot is not published elsewhere; however, the full protocol for the hybrid trial can be found here: https://clinicaltrials.gov/ct2/show/NCT05000632 . TRIAL REGISTRATION: NCT, NCT05000632. Registered 14 July 2021, there is not a separate registration number for the pilot.

An Early Palliative Care Telehealth Coaching Intervention to Enhance Advanced Cancer Family Caregivers' Decision Support Skills: The CASCADE Pilot Factorial Trial.

CONTEXT: Patients with advanced cancer often involve family caregivers in health-related decision-making from diagnosis to end-of-life; however, few interventions have been developed to enhance caregiver decision support skills. OBJECTIVES: Assess the feasibility, acceptability, and potential efficacy of individual intervention components of CASCADE (CAre Supporters Coached to be Adept DEcision Partners), an early telehealth, palliative care coach-led decision support training intervention for caregivers. METHODS: Pilot factorial trial using the multiphase optimization strategy (October 2019-October 2020). Family caregivers and their care recipients with newly-diagnosed advanced cancer (n = 46 dyads) were randomized to1 of 8 experimental conditions that included a combination of one of the following three CASCADE components: 1) effective decision support psychoeducation; 2) decision support communication training; and 3) Ottawa Decision Guide training. Feasibility was assessed by completion of sessions and questionnaires (predefined as ≥80%). Acceptability was determined through postintervention interviews and participants' ratings of their likelihood to recommend. Measures of effective decision support and caregiver and patient distress were collected at Twelve and Twenty four weeks. RESULTS: Caregiver participants completed 78% of intervention sessions and 81% of questionnaires; patients completed 80% of questionnaires. Across conditions, average caregiver ratings for recommending the program to others was 9.9 on a scale from 1-Not at all likely to 10-Extremely likely. Individual CASCADE components were observed to have potential benefit for effective decision support and caregiver distress. CONCLUSION: We successfully piloted a factorial trial design to examine components of a novel intervention to enhance the decision support skills of advanced cancer family caregivers. A fully-powered factorial trial is warranted. KEY MESSAGE: We pilot tested components of CASCADE, an early palliative care decision support training intervention for family caregivers of patients with advanced cancer. CASCADE components were acceptable and the trial design feasible, providing promising future directions for palliative care intervention development and testing. Pilot results will inform a fully-powered trial.

Applying the Multiphase Optimization Strategy for the Development of Optimized Interventions in Palliative Care.

Recent systematic reviews and meta-analyses have reported positive benefit of multicomponent "bundled" palliative care interventions for patients and family caregivers while highlighting limitations in determining key elements and mechanisms of improvement. Traditional research approaches, such as the randomized controlled trial (RCT), typically treat interventions as "bundled" treatment packages, making it difficult to assess definitively which aspects of an intervention can be reduced or replaced or whether there are synergistic or antagonistic interactions between intervention components. Progressing toward palliative care interventions that are effective, efficient, and scalable will require new strategies and novel approaches. One such approach is the Multiphase Optimization Strategy (MOST), a framework informed by engineering principles, that uses a systematic process to empirically identify an intervention comprised of components that positively contribute to desired outcomes under real-life constraints. This article provides a brief overview and application of MOST and factorial trial design in palliative care research, including our insights from conducting a pilot factorial trial of an early palliative care intervention to enhance the decision support skills of advanced cancer family caregivers (Project CASCADE).

Linking Patterns of Substance Use With Sexual Risk-Taking Among Female Adolescents With and Without Histories of Maltreatment.

PURPOSE: This study aimed to determine the associations between patterns of substance use and sexual risk-taking among female adolescents with and without histories of maltreatment. METHODS: Data are from a prospective cohort study examining the impact of maltreatment on subsequent female adolescent sexual health (N = 504). Participants averaged 18.24 years in age (SD = 1.12), and approximately 63% had substantiated incidences of maltreatment filed with Child Protective Services prior to age 18. The present study used latent class analysis to examine patterns in adolescent substance use, and negative binomial regression models to examine the links between patterns of substance use and sexual risk-taking and to determine whether these associations were moderated by adolescents' maltreatment status. RESULTS: Six classes emerged from latent class analysis labeled as follows: abstainers (25% of sample); polysubstance users-early initiators (13%); polysubstance users-late initiators (23%); alcohol and cannabis users-late initiators (9%); alcohol users-late initiators (18%); and tobacco users (12%). Patterns of adolescent polysubstance use were associated with the highest levels of sexual risk-taking, and patterns of late-initiated polysubstance use, late-initiated alcohol use, and tobacco use were more strongly related to sexual risk-taking for female adolescents with histories of maltreatment. CONCLUSIONS: This study is the first to determine the specific patterns of substance use that are more strongly related to sexual risk-taking for maltreated female adolescents. By doing so, this study demonstrates how a person-centered approach can facilitate our understanding of how to best leverage sexual risk-taking prevention efforts.