SONATA: A Single Arm Pilot Trial of a Social Network Intervention
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 - SONATA 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.
|
Outcome Measures
Primary Outcome Measures
- Feasibility - SONATA Intervention [20 Weeks]
Number of patients approached who consent
- Acceptability- SONATA Intervention [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 Outcome Measures
- Estimate - Social Support [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 [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 [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.
Eligibility Criteria
Criteria
Patient
Inclusion Criteria:
-
Age ≥65 years
-
A diagnosis of cancer
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Planning to initiate or during first three months of oral anticancer treatments
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Able to identify at least one network member to participate with them
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Able to speak English
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Able to provide informed consent
Exclusion Criteria:
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Any psychiatric or cognitive impairments interfering with participation as determined by the treating oncology team
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Enrolled on oral anticancer therapeutic trials
Network Members:
Inclusion Criteria:
-
Age ≥18 years
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Identified as a network member by subjects enrolled on the study (up to 10 network members)
-
Able to provide informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Rochester | Rochester | New York | United States | 14642 |
Sponsors and Collaborators
- University of Rochester
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UOCPC22065