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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

256

participants targeted

Target at P75+ for not_applicable

Timeline

1mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach

1 country

2 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.5 years study duration

Study Progress97%

Jan 2022Jun 2026

First Submitted

Initial submission to the registry

March 15, 2021

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed

10 months until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed

4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

March 15, 2021

Last Update Submit

March 10, 2026

Conditions

Cancer Family Members

Keywords

family caregiverdecision-makingmultiphase optimization strategyfactorial trial

Outcome Measures

Primary Outcomes (1)

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 Outcomes (5)

Patient distress as measured by the Hospital Anxiety and Depression Scale
Baseline to 24 weeks
Patient quality of life as measured by the PROMIS Global Health 10
Baseline to 24 weeks
Patient healthcare utilization including advance directive completion as reported by family caregivers
Baseline to 24 weeks
Caregiver distress as measured by the Hospital Anxiety and Depression Scale
Baseline to 24 weeks
Caregiver quality of life as measured by the PROMIS Global Health 10
Baseline to 24 weeks

Study Arms (16)

Basic social support + communication + Ottawa guide + 1 monthly follow up call

EXPERIMENTAL

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