A Single Arm Pilot Trial of a Social Network Intervention (SONATA) for Older Patients With Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of Rochester
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Acceptability- SONATA Intervention
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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 \[average patient subject general acceptability score ≥4 (range one to five) using the Theoretical Framework of Acceptability questionnaire.\]
Investigators
Kah Poh Loh
Associate Professor - Department of Medicine, Hematology/Oncology (SMD)
University of Rochester
Eligibility Criteria
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
- •1\) 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:
Outcomes
Primary Outcomes
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.
Feasibility - SONATA Intervention
Time Frame: 20 Weeks
Number of patients approached who consent
Secondary Outcomes
- Estimate - Trust in Healthcare Professionals(20 Weeks)
- Estimate - Social Support(20 Weeks)
- Estimate - Adherence to oral anticancer treatments(20 Weeks)