A Single Arm Pilot Trial of a Social Network Intervention

NCT05745038 | Recruiting DMC

• 1 other identifier: UOCPC22065
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

geriatric oncology

Outcome Measures

Primary Outcomes (2)

• Feasibility - SONATA Intervention

  Number of patients approached who consent

  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.

  20 Weeks

Secondary Outcomes (3)

• Estimate - Social Support

  20 Weeks

• Estimate - Trust in Healthcare Professionals

  20 Weeks

• Estimate - Adherence to oral anticancer treatments

  20 Weeks

Study Arms (1)

Arm 1 - SONATA Intervention

EXPERIMENTAL

Behavioral: SONATA

Interventions

SONATA BEHAVIORAL

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.

Arm 1 - SONATA Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 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 primary oncology team
• Network Members:
• Age ≥18 years
• Identified as a network member by patient subjects (up to 10 network members)
• Able to speak English
• Able to provide informed consent.
• None

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

zaleplon

Study Officials

• Kah Poh Loh

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kah Poh Loh

CONTACT

585-276-4353; Kahpoh_Loh@URMC.Rochester.edu

Becky Gravenstede

CONTACT

585-727-4728; becky_gravenstede@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Medicine, Hematology/Oncology (SMD)

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 27, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available for 7 years from accrual of the first subject.

Locations

US (1)