A Single Arm Pilot Trial of a Social Network Intervention (SONATA)

A Single Arm Pilot Trial of a Social Network Intervention (SONATA) for Older Patients on Oral Anticancer Treatments and Their Network Members

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: SONATA

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Mitchell; Phone Number: 585-275-1192; Email: Lauren_Mitchell@URMC.rochester.edu
• Study Contact Backup: Name: Kah Poh Loh; Phone Number: 585-276-4353; Email: Kahpoh_Loh@URMC.Rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Contact: Kah Poh Loh; Phone Number: 585-276-4353; Email: Kahpoh_Loh@URMC.Rochester.edu
      • Principal Investigator: Kah Poh Loh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Patient

Inclusion Criteria:

• Age ≥65 years
• A diagnosis of cancer
• Planning to initiate or during first three months of oral anticancer treatments
• Able to identify at least one network member to participate with them
• Able to speak English
• Able to provide informed consent

Exclusion Criteria:

• Any psychiatric or cognitive impairments interfering with participation as determined by the treating oncology team
• Enrolled on oral anticancer therapeutic trials

Network Members:

Inclusion Criteria:

1. Age ≥18 years
2. Identified as a network member by subjects enrolled on the study (up to 10 network members)
3. Able to speak English.
4. Able to provide informed consent

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - SONATA Intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - SONATA Intervention	Number of patients approached who consent	20 Weeks
Acceptability- SONATA Intervention	Average general acceptability score using the Theoretical Framework of Acceptability questionnaire. An eight item (range 1 to 5 for each item) psychometrically validated and theoretically informed tool which assesses the following constructs - affective attitude, burden, ethicality, perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, and general acceptability.	20 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate - Trust in Healthcare Professionals	Assessed using the the Human Connection (THC) Scale. The THC scale is A 16-item scale (range 1 to 4 for each item); higher scores indicate greater trust.	20 Weeks
Estimate - Adherence to oral anticancer treatments	Assessed using the Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence). The DOSE-Nonadherence scale is a three-item scale (range from none of the time to every time for each item) with eighteen additional items that assesses reasons for non-adherence.	20 Weeks
Estimate - Social Support	Assessed using the Medical Outcomes Study Social Support Survey. The Medical Outcomes Study Social Support Survey is a 19-item survey (range 1-5 for each item) to assess four domains of emotional/informational support, instrumental support, positive social interaction, and affection; higher scores indicate greater social support. Subjects will be asked about their perceptions of their own social support.	20 Weeks

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: geriatric oncology
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Modulators; GABA Agents; Anticonvulsants; Zaleplon
• Other Study ID Numbers: UOCPC22065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol and dataset will be shared upon request from the PI
• IPD Sharing Time Frame: The data will be available for 7 years from accrual of the first subject.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No