A Pilot Randomized Controlled Trial of a Social Network Intervention (SONATA 2)

April 10, 2026 updated by: Kah Poh Loh, University of Rochester

A Pilot Randomized Controlled Trial of a Social Network Intervention for Older Patients With Cancer

This is a pilot randomized controlled trial to assess the feasibility, acceptability, appropriateness, and structure of the SONATA intervention. In addition, it will assess the preliminary efficacy of SONATA compared to enhanced usual care among 70 older adults with advanced cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Older adults (aged ≥65) with advanced cancer are living longer due to more effective treatments, but their median survival remains around one year. We have shown that this population experiences a high prevalence of aging-related conditions, including functional and cognitive impairments, as well as depressive and anxiety symptoms. These conditions heighten their vulnerability to treatment toxicities and increase their need for assistance with daily activities. Together, these challenges impair older adults' ability to manage their care (patient activation) and reduce their overall quality of life (QoL). Therefore, interventions are needed to increase patient activation and improve QoL in this vulnerable population.

Fostering supportive social networks (SNs) can help older adults navigate the burden of cancer and its treatments. SNs comprise individuals (e.g., family members and friends) connected by interpersonal relationships. SN members offer a range of support, including instrumental, emotional, and informational support. They play pivotal roles in clinical settings, particularly for older individuals with functional impairments. SN members attend clinic visits and advocate for patients, ensuring accurate exchange and filtering of information to align with patients' preferences. SN members also shape patients' identities, coping strategies, and disease understanding. The role of SNs becomes more prominent as older adults become more ill.

The SOcial Networks to Activate Teamwork & Alliance (SONATA) intervention was designed to harness the SNs to provide support to older adults with advanced cancer and increase patient activation and improve QoL. The objective of this study is to conduct a pilot randomized controlled trial assessing SONATA compared to enhanced usual care among 70 older adults with advanced cancer.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Patients

Inclusion criteria:

  • Age ≥65 years
  • A diagnosis of advanced or likely incurable cancer, as determined by the primary oncologist
  • Able to speak English
  • Able to provide informed consent

Exclusion criteria:

  • Any psychiatric or cognitive impairments interfering with participation as determined by the oncology team
  • Unwilling to complete study procedures

Social Network Members (if available, for intervention arm only)

Inclusion criteria:

  • Age ≥18 years
  • Identified as an SN member by the patient in the intervention arm
  • Able to speak English
  • Able to provide informed consent

Exclusion criteria:

• Unwilling to complete study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SONATA Intervention
Following randomization, patients assigned to SONATA will participate in up to six coaching sessions, delivered either in person or via Zoom over approximately six weeks.
Behavioral: SONATA
SONATA includes six evidence-based components to help patients: 1) identify and set personal goals to achieve well-being (goal-setting); 2) identify their social network (SN) members and map their SNs (network diagnostics); 3) engage key SN members to address their goals and needs (network engagement); 4) build channels for communication and collaboration with key SN members via in-person and virtual activities (opportunity creation); 5) communicate effectively with their key SN members, develop action plans, and provide support (skill building); and 6) engage in cycles of feedback to effectively respond to the patient's evolving needs.
No Intervention: Enhanced Usual Care
Patients randomized to enhanced usual care will receive standard educational materials within 4 weeks of randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study feasibility
Time Frame: From baseline to week 16
Retention rate. Percentage of patients who complete at least three SONATA sessions and week 16 post-intervention assessments
From baseline to week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional, social, and existential quality of life
Time Frame: From baseline to week 16
14-item McGill QoL Questionnaire-Revised. A 14-item survey assessing quality of life. It has four subscales: Physical, Psychological, Existential, and Social. We will focus on Psychological, Existential, and Social subscales. Mean scores range from 0 to 10, higher scores are better
From baseline to week 16
Patient Activation
Time Frame: From baseline to week 16.
Patient Activation Measure. A 13-item survey to assess patient knowledge, skill, and confidence for self-management. Total scores range from 0 to 100, higher scores are better.
From baseline to week 16.
Autonomy, Competence, and Relatedness
Time Frame: From baseline to week 16
Basic Psychological Need Satisfaction Scale. A 21-item survey to assess the degree to which people feel satisfaction of these three needs - autonomy, competence, and connectedness. Total scores range fom 21 to 147, higher scores are better.
From baseline to week 16
Social Support
Time Frame: From baseline to week 16
Medical Outcomes Study-Social Support Survey. A 19-item survey to assess four domains of emotional/informational support, instrumental support, positive social interaction, and affection. Total scores range from 0-100, higher scores are better.
From baseline to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Kah Poh Loh, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOCPC26005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Permission will also be asked on the consent form for the use of patient and social network (SN) data for future research not described in this consent. In addition, permission will be asked from patients and SN members to share de-identified transcripts from recordings for future research not described in the consent.

IPD Sharing Time Frame

All study data will be kept for a period of 7 years after the date of study closure.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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