A Single Arm Pilot Trial of a Social Network Intervention

Not Applicable

Recruiting

• Conditions: Cancer
• Interventions: Behavioral: SONATA

• Registration Number: NCT05745038
• Lead Sponsor: University of Rochester

Brief 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 \[average patient subject general acceptability score ≥4 (range one to five) using the Theoretical Framework of Acceptability questionnaire.\]

Study Timeline

• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Study Start: 2023-11-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Age ≥60 years
2. A diagnosis of advanced or likely incurable cancer, as determined by the primary oncologist
3. Able to speak English
4. Able to provide informed consent

Exclusion Criteria

1. Any psychiatric or cognitive impairments interfering with participation as determined by the primary oncology team

Network Members:

Inclusion Criteria:

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

Exclusion Criteria:

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1 - SONATA Intervention	SONATA	-

Primary Outcome Measures

Name	Time	Method
Acceptability- SONATA Intervention	20 Weeks	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.
Feasibility - SONATA Intervention	20 Weeks	Number of patients approached who consent

Secondary Outcome Measures

Name	Time	Method
Estimate - Trust in Healthcare Professionals	20 Weeks	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.
Estimate - Social Support	20 Weeks	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.
Estimate - Adherence to oral anticancer treatments	20 Weeks	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.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States