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Clinical Trial Summary

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, for the first time, an optimization trial approach to develop and refine the decision partnering skills of family caregivers of persons with newly-diagnosed advanced cancer. Using a 2x2x2 full factorial design, 40 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more nurse coach-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory4: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision partnering communication training (yes vs. no); and 3) Ottawa Decision Guide training (yes vs. no).


Clinical Trial Description

A priority focus in palliative care, oncology, and geriatrics is preparing the 2.8 million U.S. family caregivers of persons with cancer to effectively partner with patients in healthcare decision-making from diagnosis to the end of life. Over 70% of patients with cancer report involvement by relatives, friends, and partners in healthcare decisions, including choices about cancer treatments, surgery, transitions and location of care, accessing palliative and hospice care, and many others. Hence, there is a critical need to train cancer family caregivers to be supportive of patient decision-making; however, few palliative care interventions exist that enhance skills in effective decision partnering. Patients making healthcare decisions with unprepared family caregivers may experience inadequate family decision support leading to heightened distress and receipt of care/treatments inconsistent with their values and preferences. This in turn may increase distress for family caregivers.

Becoming better decision partners with patients is one among several skills targeted within our evidence-based model of early concurrent oncology palliative care for family caregivers. Decision partnering relevant content for family caregivers has included principles of effective social support, communication, and Ottawa Decision Guide training; however it is unknown which of these components and component interactions influences patient and caregiver decision-making outcomes. Traditional research approaches typically treat interventions as "bundled" treatment packages, making it difficult to assess definitively which aspects of an intervention can be reduced, eliminated, or replaced to improve efficiency. Using traditional research methods (e.g., two-arm randomized controlled trials that test new features one at a time) requires conducting multiple studies, which is an exorbitantly expensive and time consuming process. This paradox prompts us to consider methodologies that may offer a more efficient way to test multiple intervention components simultaneously.

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, for the first time, an optimization trial approach to develop and refine the decision partnering skills of family caregivers of persons with newly-diagnosed advanced cancer (CASCADE: CAre Supporters Coached to be Adept DEcision partners). Using a 2x2x2 factorial design, 40 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more nurse coach-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory4: 1) psychoeducation on effective decision partnering and social support principles (1 vs. 3 sessions); 2) decision support communication training (yes vs. no); and 3) Ottawa Decision Guide training (yes vs. no).

This study's conceptual foundations incorporate Rini's Social Support Effectiveness Theory and the Ottawa Decision Support Framework. Caregiver decision partnering training is designed to modify family caregiver skills, including their ability to: 1) provide effective social support through psychoeducation on key social support principles that will optimize emotional and informational support to patients; 2) elicit patient decisional needs, including patient values, preferences, and coping through better decision support communication, enhancing the quantity of decision-making conversations; and 3) provide structured decision support using an evidence-based tool (i.e., the Ottawa Decision Guide, see Appendix) to help patients clarify choices and guide deliberation through Ottawa decision guide training, reducing patient decision conflict. Modification of these skills and improvement in patient mediating outcomes is hypothesized to lead to more positive decisional influence from the patient's perspective and better patient and caregiver mood.

The specific aims of this study are to:

Aim 1: Determine the feasibility and acceptability of using a highly innovative experimental design to enroll and retain 40 caregivers for 24 weeks to complete 1 or more components of caregiver decision partnering training. Feasibility: ≥80% of participants will adhere to and complete assigned intervention components and study-related assessments. Acceptability: Through post-intervention qualitative interviews, the investigators will elicit feedback from caregiver participants on intervention experiences and clinical trial procedures.

Aim 2: Explore the preliminary efficacy of individual decision partnering training components and component interactions on patient and caregiver outcomes at 12 and 24 weeks after baseline, including a) patient-reported positive decision influence (primary) using Rini's Decision Influence Scale and b) patient and caregiver mood (depression/anxiety symptoms) using the Hospital Anxiety and Depression Scale.

Exploratory Aim: Explore mediators and moderators (e.g., sociodemographics, coping, social support, decisional conflict) of the relationship between intervention components and patient and caregiver outcomes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03947606
Study type Interventional
Source University of Alabama at Birmingham
Contact James N Dionne-Odom, PhD
Phone 2059347597
Email dionneod@uab.edu
Status Not yet recruiting
Phase N/A
Start date October 1, 2019
Completion date June 30, 2021

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