A Pilot Randomized Controlled Trial of a Social Network Intervention
SONATA 2
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2026
CompletedFirst Posted
Study publicly available on registry
February 6, 2026
CompletedStudy Start
First participant enrolled
April 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
April 15, 2026
April 1, 2026
3 years
January 30, 2026
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Study feasibility
Retention rate. Percentage of patients who complete at least three SONATA sessions and week 16 post-intervention assessments
From baseline to week 16
Secondary Outcomes (4)
Emotional, social, and existential quality of life
From baseline to week 16
Patient Activation
From baseline to week 16.
Autonomy, Competence, and Relatedness
From baseline to week 16
Social Support
From baseline to week 16
Study Arms (2)
SONATA Intervention
EXPERIMENTALFollowing randomization, patients assigned to SONATA will participate in up to six coaching sessions, delivered either in person or via Zoom over approximately six weeks.
Enhanced Usual Care
NO INTERVENTIONPatients randomized to enhanced usual care will receive standard educational materials within 4 weeks of randomization.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Age ≥18 years
- Identified as an SN member by the patient in the intervention arm
- Able to speak English
- Able to provide informed consent
- Unwilling to complete study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- American Cancer Society, Inc.collaborator
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
Related Publications (2)
Kehoe L, Sanapala C, DiGiovanni G, Yousefi-Nooraie R, Yilmaz S, Bauer J, Loh KP, Norton S, Duberstein P, Kamen C, Gilmore N, Gudina A, Kleckner A, Mohile S, Epstein RM. Older adults with advanced cancer are selective in sharing and seeking information with social networks. Patient Educ Couns. 2022 Oct;105(10):3116-3122. doi: 10.1016/j.pec.2022.06.005. Epub 2022 Jun 9.
PMID: 35717349BACKGROUNDYu V, Yilmaz S, Freitag J, Loh KP, Kehoe L, Digiovanni G, Bauer J, Sanapala C, Epstein RM, Yousefi-Nooraie R, Mohile S. The role of social networks in prognostic understanding of older adults with advanced cancer. Patient Educ Couns. 2023 Jan;106:135-141. doi: 10.1016/j.pec.2022.10.009. Epub 2022 Oct 15.
PMID: 36270857BACKGROUND
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Kah Poh Loh
University of Rochester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 30, 2026
First Posted
February 6, 2026
Study Start
April 10, 2026
Primary Completion (Estimated)
March 31, 2029
Study Completion (Estimated)
March 31, 2029
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- All study data will be kept for a period of 7 years after the date of study closure.
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.