University of Rochester
Rochester, New York, 14642, United States
Location status: Recruiting
Recruiting
NCT Number: NCT05745038
A Single Arm Pilot Trial of a Social Network Intervention
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.
Recruiting
Interested in participating?
Request InfoKey information
About this study
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.]
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient
Inclusion criteria
- 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
Exclusion criteria
- Any psychiatric or cognitive impairments interfering with participation as determined by the primary oncology team
Network Members:
Inclusion criteria
- 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.
Exclusion criteria
None
Treatment and study plan
SONATA
BehavioralThe 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.
Primary outcomes
-
Feasibility - SONATA Intervention
Time frame: 20 Weeks
Number of patients approached who consent
-
Acceptability- SONATA Intervention
Time frame: 20 Weeks
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.
Secondary outcomes
-
Estimate - Social Support
Time frame: 20 Weeks
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.
-
Estimate - Trust in Healthcare Professionals
Time frame: 20 Weeks
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.
-
Estimate - Adherence to oral anticancer treatments
Time frame: 20 Weeks
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Becky Gravenstede
CONTACT
Kah Poh Loh
CONTACT
Sponsors and collaborators
Lead sponsor
University of Rochester
Other
Registry information
Official study title
A Single Arm Pilot Trial of a Social Network Intervention (SONATA) for Older Patients With Cancer
Acronym: SONATA
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Feb 27, 2023
- Registry last updated
- Mar 31, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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