Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT05745038

Recruiting

SONATA: A Single Arm Pilot Trial of a Social Network Intervention

Interventional

Phase not listed

University of Rochester

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.

Show Detailed Description

Treatment Category

Behavioral

Required Mutations

None

Trial Started

2023-11-29

Last Updated by Sponsor

2025-09-26

Estimated Completion

2027-12-31

Eligibility

Inclusion Criteria

Patient

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

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

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

Network Members:

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll220

Arms & Interventions

Arms

Interventions

Type: Experimental

Description:

Interventions:

SONATA

Outcome Measures

Primary Outcome Measures

Feasibility - SONATA Intervention20 Weeks

Number of patients approached who consent

Acceptability- SONATA Intervention20 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.

Secondary Outcome Measures

Estimate - Trust in Healthcare Professionals20 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 - Adherence to oral anticancer treatments20 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.

Estimate - Social Support20 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.