NCT05297734

Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,996 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.

Detailed description

PRIMARY OBJECTIVES: I. Greater intervention effects on health-related quality of life SECONDARY OBJECTIVES: I. Greater intervention effects on patient activation II. Greater satisfaction with care and decision-making III. Greater documentation of goals of care and symptoms IV. To lower acute care V. Greater palliative care and hospice OUTLINE: Sites are randomized to 1 of 2 arms. ARM A: Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12. ARM B: Patients are paired with a lay health worker who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12. All participants complete a baseline interview upon enrollment during the initial consent phone contact and then a survey at 3-, 6-and 12-months post enrollment.

Conditions

• End of Life
• Cancer

Interventions

Type	Name	Description
OTHER	Receive technology-based supportive cancer care	All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.
BEHAVIORAL	Receive redesigned team-based supportive cancer care	Lay Health Workers will meet with 1:1 with participants over 12 months to discuss advance care planning, surrogate decision-makers, advance directives and physician orders for life sustaining treatment.

Timeline

• Start date: 2022-06-24
• Primary completion: 2028-01-31
• Completion: 2028-02-28
• First posted: 2022-03-28
• Last updated: 2025-03-19

Locations

17 sites across 1 country: United States