Clinical trial NCT04803604: Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial
Official title: Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Family Members
Cancer
Keywords: family caregiver
decision-making
multiphase optimization strategy
factorial trial
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-03-17
Enrollment: 256
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2x2x2 full factorial pilot randomized trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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, 256 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).

Detailed description: 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, 256 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.

Eligibility criteria: FAMILY CAREGIVERS

Inclusion Criteria:

1. ≥21 years of age;
2. self-endorsing or identified by the patient as "a relative, friend, or partner that has a close relationship with you and who assists you with your medical decisions and who may or may not live in the same residence as you and who is not paid for their help";
3. caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below);
4. caregivers will need to have an agreeable patient willing to participate in the study for data collection; and
5. English-speaking and able to complete baseline measures.

Exclusion Criteria:

1) Self-reported mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.

PATIENTS

Inclusion Criteria:

1. ≥21 years of age;
2. diagnosed within 60 days of initial screening with an advanced cancer, defined as metastatic and/or recurrent/progressive stage III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, melanoma, and hematologic malignancies.

Exclusion Criteria:

1) Medical record documentation of active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.

Primary outcomes:
measure: Patient reported decisional conflict using the Decisional Conflict Scale
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Patient distress as measured by the Hospital Anxiety and Depression Scale
timeFrame: Baseline to 24 weeks
measure: Patient quality of life as measured by the PROMIS Global Health 10
timeFrame: Baseline to 24 weeks
measure: Patient healthcare utilization including advance directive completion as reported by family caregivers
timeFrame: Baseline to 24 weeks
measure: Caregiver distress as measured by the Hospital Anxiety and Depression Scale
timeFrame: Baseline to 24 weeks
measure: Caregiver quality of life as measured by the PROMIS Global Health 10
timeFrame: Baseline to 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
References: