A Single Arm Pilot Trial of a Social Network Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SONATA.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single Arm Pilot Trial of a Social Network Intervention (SONATA) for Older Patients With Cancer
Overview
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 \[average patient subject general acceptability score ≥4 (range one to five) using the Theoretical Framework of Acceptability questionnaire.\]
Interventions
- 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.
Primary outcome measures
- Feasibility - SONATA Intervention [Time frame: 20 Weeks]
- Acceptability- SONATA Intervention [Time frame: 20 Weeks]
Secondary outcome measures (3)
- Estimate - Social Support [Time frame: 20 Weeks]
- Estimate - Trust in Healthcare Professionals [Time frame: 20 Weeks]
- Estimate - Adherence to oral anticancer treatments [Time frame: 20 Weeks]
Eligibility criteria
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
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
None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Rochester — Rochester
Identifiers
NCT: NCT05745038 · UOCPC22065