NCT05745038

A Single Arm Pilot Trial of a Social Network Intervention

A Single Arm Pilot Trial of a Social Network Intervention (SONATA) for Older Patients With Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if a social network support program (SOcial Networks to Activate Trust \& Adherence or SONATA) is helpful for older individuals receiving cancer treatment. The SONATA program will last for about 4 months. There are a total of 6 coaching sessions. The first 5 sessions will be held approximately every 1 to 2 weeks. Session 6 or the final session will be held approximately 1 to 2 months after session 5. Each session will last for about 1 to 2 hours.

Detailed description

The objective of this study is to conduct a single arm pilot study to assess the feasibility and acceptability of the SONATA intervention among older patients with advanced cancer. We hypothesize that the SONATA intervention will be feasible \[≥70% enrolled patient subjects (excluding those who die during the study) will complete at least 3 of the SONATA sessions\] and acceptable \[average patient subject general acceptability score ≥4 (range one to five) using the Theoretical Framework of Acceptability questionnaire.\]

Conditions

• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	SONATA	The SONATA intervention is composed of five components, network diagnostics, network engagement, opportunity creation, skill building and goal-setting, and feedback, that will be audio-recorded and held over six scheduled sessions.

Timeline

• Start date: 2023-11-29
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2023-02-27
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States