3 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and a single monthly follow-up call

3 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and monthly follow-up calls for 6 months

2 in-person/telephone weekly sessions on providing social support, tips for good communication, and a single monthly follow-up call

2 in-person/telephone weekly sessions on providing social support, tips for good communication, and monthly follow-up calls for 6 months

2 in-person/telephone weekly sessions on 1 coaching session on providing social support, decision support tools, and a single monthly follow-up call

2 in-person/telephone weekly sessions on providing social support, decision support tools, and monthly follow-up calls for 6 months

1 in-person/telephone weekly sessions on providing social support and a single monthly follow-up call

1 in-person/telephone weekly sessions on providing social support and monthly follow-up calls for 6 months

5 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and a single monthly follow-up call

5 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and monthly follow-up calls for 6

4 in-person/telephone weekly sessions on providing social support, tips for good communication, and a single monthly follow-up call

4 in-person/telephone weekly sessions on providing social support, tips for good communication, and monthly follow-up calls for 6 months

4 in-person/telephone weekly sessions on providing social support, decision support tools, and a single monthly follow-up call

4 in-person/telephone weekly sessions on providing social support, decision support tools, and monthly follow-up calls for 6 months

3 in-person/telephone weekly sessions on providing social support, and a single monthly follow-up call

3 in-person/telephone weekly sessions on providing social support, and monthly follow-up calls for 6 months

CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.

CASCADE (CAre Supporters Coached to be Adept DEcision partners)

Peggy McKie, MPH

Sally Engler, MPH

Jane Lowers, PhD

Dio Kavalieratos, PhD

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial trial is to identify components of a intervention (CASCADE) to enhance the decision support skills of family caregivers of persons with newly-diagnosed advanced cancer. Using a 2x2x2x2 full factorial design, 352 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 Theory: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision partnering communication training (yes vs. no); 3) Ottawa Decision Guide training (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).

A priority focus in oncology and palliative care is preparing the 3.2 million U.S. family caregivers of persons with cancer to effectively partner with patients in health-related decision-making from diagnosis to the end of life, particularly in underserved settings. Over 70% of patients with cancer involve 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. 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. Hence, there is a critical need to train cancer family caregivers to effectively support patient decision-making; however, few interventions exist that enhance caregiver skills in providing decision support.

We have developed and successfully pilot tested CASCADE (CAre Supporters Coached to be Adept DEcision partners), a lay navigator-led, telehealth early palliative care intervention to train advanced cancer caregivers how to effectively partner with patients in health-related decision-making. Evolving out of our prior early palliative care caregiving interventions, decision partnering relevant content for family caregivers includes principles of effective social support in decision-making, decision support communication, and Ottawa Decision Guide training; however we do not know 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 offer a more efficient way to test multiple intervention components simultaneously. The research question we raise is: "What set of decision support training components best optimizes family caregiver support of patient healthcare decision-making?"

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to conduct an optimization trial to develop and refine the decision support skills of family caregivers of persons with newly-diagnosed advanced cancer (CASCADE: CAre Supporters Coached to be Adept DEcision partners). Using a 2x2x2x2 factorial design, 352 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more lay coach-delivered decision support training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory: 1) psychoeducation on effective decision support and social support principles (1 vs. 3 sessions); 2) decision support communication training (yes vs. no); 3) Ottawa Decision Guide training (yes vs. no); and 4) monthly follow-up (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).

The specific aims of this study are to:

Aim 1: Identify CASCADE decision support training components (main effects/interactions) that contribute meaningfully to improvement over 24 weeks in the primary outcome, patient-reported decisional conflict, measured by the Decisional Conflict Scale and secondary outcomes, including:

Caregivers: a) distress (Hospital Anxiety and Depression Scale),42 b) quality of life (PROMIS Global 10) Patients: a) distress (Hospital Anxiety and Depression Scale), b) quality of life (PROMIS Global 10), c) healthcare utilization, d) advance directive completion. A component will be considered effective if its presence produces a statistically significant main effect or two-way interaction of Cohen's d ≥.30.

Aim 2: Apply results obtained in Aim 1 to build: (1) an intervention made up of only active components and (2) a second intervention that is optimized for scalability and cost. Intervention (1) will be made up of the best set of component and component levels, based on Aim 1 results. Intervention (2) will be comprised of the set of components for the smallest cost that still yields a clinically meaningful effect in outcomes (d≥.30).

Exploratory Aim: Explore mediators and moderators (e.g., sociodemographics, decision self-efficacy, social support) of the relationship between intervention components and patient and caregiver outcomes.

2x2x2x2 full factorial pilot randomized trial

Data collectors and principal investigator will be blind to participant condition; participants will be instructed NOT to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the lay coach involved in delivering the intervention.

Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial

16-item measure; perceptions of uncertainty in choosing options, factors contributing to uncertainty (e.g., feeling uninformed, unclear values) and feeling that decisions were informed and values-based.

14 items total, 7 items measure anxiety (e.g., feeling tense, restless, worry), 7 items measure depressive symptoms (e.g., cheerfulness, feeling slowed down). Higher scores=worse anxiety/depression.

10 items, measures global health-related quality of life (HRQOL) in 2 domains: physical and mental health; scoring allows for estimates of cost effectiveness. Higher scores=higher HRQOL.

Inpatient days, ICU days, ED visits, urgent care visits, hospice use, palliative care provider visits, advance care planning conversations, advance directive completion, DNR orders

0 items, measures global health-related quality of life (HRQOL) in 2 domains: physical and mental health; scoring allows for estimates of cost effectiveness. Higher scores=higher HRQOL.

National Cancer Institute (NCI)

University of Alabama at Birmingham

Assistant Professor

3 in-person/telephone weekly sessions on providing decision social support, tips for good communication, and decision support tools

2 in-person/telephone weekly sessions on providing decision social support and tips for good communication

2 in-person/telephone weekly sessions on providing decision social support and decision support tools

1 in-person/telephone weekly session on providing decision social support

5 in-person/telephone weekly sessions on providing decision social support, tips for good communication, and decision support tools

4 in-person/telephone weekly sessions on providing decision social support and tips for good communication

4 in-person/telephone weekly sessions on providing decision social support and decision support tools

3 in-person/telephone weekly sessions on providing decision social support

CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, nurse coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training.

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).

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.

2x2x2 full factorial pilot randomized trial

Data collectors and principal investigator will be blind to participant condition; participants will be instructed NOT to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the nurse coach involved in delivering the intervention.

Pilot Optimization Trial of Decision Partnering Intervention for Advanced Cancer Family Caregivers

An Optimization Trial to Prepare Advanced Cancer Caregivers for Decision Partnering Using the Multiphase Optimization Strategy (MOST)

Proportion of caregiver participants who complete assigned intervention components and proportion of caregiver and patient participants who complete study-related assessments.

Through qualitative interviews, caregiver participant reported experiences with the CASCADE intervention and trial procedures.

30 items; assesses satisfaction with how family caregivers assist patient's with healthcare decision-making, such as acting angry, questioning or doubting the patient's decisions, failing to assist, making useful suggestions, listening, and offering helpful advice. Total score range: 37-185; higher scores=more positive decision influence by family member.

14 items; measures symptoms of anxiousness and depressed mood. 7 items measure anxiety (e.g., feeling tense, restless, worried) and 7 items measure depressive symptoms (e.g., cheerfulness, feeling slowed down. Subscale score ranges: 0-21; higher scores=worse anxiety or depressive symptoms. Total score range: 0-42; higher scores=worse overall distress.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial	NCT04803604	Family Members Cancer	CASCADE (CAre S...	21 Years -	University of Alabama at Birmingham
Pilot Optimization Trial of Decision Partnering Intervention for Advanced Cancer Family Caregivers	NCT03947606	Family Caregive... Cancer	CASCADE (CAre S...	18 Years -	University of Alabama at Birmingham
Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial	NCT04803604	Family Members Cancer	CASCADE (CAre S...	21 Years -	University of Alabama at Birmingham

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