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

NCT ID: NCT05745038Sponsor: University of RochesterLast updated: 2026-03-31

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

Arms & interventions

  • BehavioralSONATA

    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.

Outcome measures

Primary

  • Feasibility - SONATA Intervention

    Number of patients approached who consent

    Time frame: 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.

    Time frame: 20 Weeks

Secondary

  • Estimate - Social Support

    Time frame: 20 Weeks

  • Estimate - Trust in Healthcare Professionals

    Time frame: 20 Weeks

  • Estimate - Adherence to oral anticancer treatments

    Time frame: 20 Weeks

Eligibility criteria

Sex: AllAge: 60 Years and olderHealthy volunteers: No
Patient 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 locations (1)

University of Rochester

Rochester, New York, 14642

Recruiting
Kah Poh Loh · Principal Investigator
A Single Arm Pilot Trial of a Social Network Intervention | Cancerify