A Single Arm Pilot Trial of a Social Network Intervention

Cancer Clinical Trial

— SONATA  

Official title:

A Single Arm Pilot Trial of a Social Network Intervention (SONATA) for Older Patients on Oral Anticancer Treatments and Their Network Members

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05745038
• Other study ID #: UOCPC22065
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: University of Rochester
• Contact: Kah Poh Loh
• Phone: 585-276-4353
• Email: Kahpoh_Loh[@]URMC.Rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Patient

Inclusion Criteria:

• Age =65 years

• A diagnosis of cancer

• Planning to initiate or during first three months of oral anticancer treatments

• Able to identify at least one network member to participate with them

• Able to speak English

• Able to provide informed consent

Exclusion Criteria:

• Any psychiatric or cognitive impairments interfering with participation as determined by the treating oncology team

• Enrolled on oral anticancer therapeutic trials

Network Members:

Inclusion Criteria:

1. Age =18 years

2. Identified as a network member by subjects enrolled on the study (up to 10 network members)

3. Able to speak English.

4. Able to provide informed consent

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - SONATA Intervention	Number of patients approached who consent	20 Weeks
Primary	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	Estimate - Social Support	Assessed using the Medical Outcomes Study Social Support Survey. The Medical Outcomes Study Social Support Survey is a 19-item survey (range 1-5 for each item) to assess four domains of emotional/informational support, instrumental support, positive social interaction, and affection; higher scores indicate greater social support. Subjects will be asked about their perceptions of their own social support.	20 Weeks
Secondary	Estimate - Trust in Healthcare Professionals	Assessed using the the Human Connection (THC) Scale. The THC scale is A 16-item scale (range 1 to 4 for each item); higher scores indicate greater trust.	20 Weeks
Secondary	Estimate - Adherence to oral anticancer treatments	Assessed using the Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence). The DOSE-Nonadherence scale is a three-item scale (range from none of the time to every time for each item) with eighteen additional items that assesses reasons for non-adherence.	20 Weeks