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

Cancer Clinical Trial

— CASCADE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803604
• Other study ID #: R01CA262039
• Status: Recruiting
• Phase: Phase 3
• Start date: January 10, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: Peggy McKie, MPH
• Phone: 205-996-0196
• Email: bellpm[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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).

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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Family Members

Intervention

Behavioral:
• CASCADE (CAre Supporters Coached to be Adept DEcision partners)
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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported decisional conflict using the Decisional Conflict Scale	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.	Baseline to 24 weeks
Secondary	Patient distress as measured by the Hospital Anxiety and Depression Scale	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.	Baseline to 24 weeks
Secondary	Patient quality of life as measured by the PROMIS Global Health 10	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.	Baseline to 24 weeks
Secondary	Patient healthcare utilization including advance directive completion as reported by family caregivers	Inpatient days, ICU days, ED visits, urgent care visits, hospice use, palliative care provider visits, advance care planning conversations, advance directive completion, DNR orders	Baseline to 24 weeks
Secondary	Caregiver distress as measured by the Hospital Anxiety and Depression Scale	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.	Baseline to 24 weeks
Secondary	Caregiver quality of life as measured by the PROMIS Global Health 10	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.	Baseline to 24 weeks