Study protocol for a pilot randomized controlled trial of SONATA: A social network intervention for older adults with advanced cancer.

INTRODUCTION: Older adults with advanced cancer often experience functional, cognitive, and psychosocial challenges that can reduce patient activation and quality of life. They also rely heavily on family, friends, and other social network members for emotional, informational, and practical support. However, few geriatric oncology interventions explicitly target personal social networks as modifiable mechanisms to improve outcomes. The SOcial Networks to Activate Teamwork & Alliance (SONATA) intervention is a theory-informed, modular social network intervention designed to help older adults with advanced cancer identify, mobilize, and optimize support from their personal networks. Guided by the Self-Determination Theory, SONATA is designed to strengthen autonomy, perceived competence, relatedness, and social support, thereby improving patient activation and quality of life. MATERIAL AND METHODS: This pilot randomized controlled trial will evaluate the feasibility and preliminary efficacy of SONATA compared with enhanced usual care. We will recruit 70 older adults aged 65 years and older with advanced or likely incurable cancer from Wilmot Cancer Institute and affiliated community oncology practices. Participants will be randomized 1:1 to SONATA or enhanced usual care. Up to two social network members per patient may enroll in the intervention arm, although patients may participate without enrolled network members. SONATA is delivered by a coach across up to six flexible sessions and includes six components: goal setting, network diagnostics, network engagement, opportunity creation, skill building, and cycles of feedback. Enhanced usual care consists of publicly available National Cancer Institute educational materials. Assessments will occur at baseline, week 8, and week 16. The primary aim is to assess feasibility, acceptability, appropriateness, and perceived structure of SONATA. Secondary aims are to assess the preliminary efficacy of SONATA versus enhanced usual care for improving patient quality of life and activation. Quantitative analyses will estimate between-group differences; qualitative interviews and egocentric network analyses will inform intervention refinement. DISCUSSION: This pilot trial will generate essential feasibility data and preliminary signals of efficacy for a network-informed supportive care intervention for older adults with advanced cancer. Findings will guide refinement of SONATA and inform the design of a future fully powered randomized trial.