A Single Arm Pilot Trial of a Social Network Intervention

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: SONATA


Participation Criteria
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Eligibility Criteria
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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: Age ≥18 years Identified as a network member by subjects enrolled on the study (up to 10 network members) Able to speak English. Able to provide informed consent Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - SONATA Intervention<br> | Behavioral: SONATA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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geriatric oncology