A Single Arm Pilot Trial of a Social Network Intervention

NCT ID: NCT05745038

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-29
• Study Completion Date: 2028-06-30

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.

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.]

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm 1 - SONATA Intervention

Group Type: EXPERIMENTAL

SONATA

Intervention Type: 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.

Interventions

SONATA

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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:

None

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Kah Poh Loh

Associate Professor - Department of Medicine, Hematology/Oncology (SMD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kah Poh Loh

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kah Poh Loh

Role: CONTACT

Kahpoh_Loh@URMC.Rochester.edu

585-276-4353

Becky Gravenstede

Role: CONTACT

becky_gravenstede@urmc.rochester.edu

585-727-4728

Facility Contacts

Kah Poh Loh

Role: primary

Kahpoh_Loh@URMC.Rochester.edu

585-276-4353

Other Identifiers

UOCPC22065

Identifier Type: -

Identifier Source: org_study_id