A Pilot Randomized Controlled Trial of a Social Network Intervention

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT07393529
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Older Adults (65 Years and Older)
  • Social Networks

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SONATA — BEHAVIORAL
    SONATA includes six evidence-based components to help patients: 1) identify and set personal goals to achieve well-being (goal-setting); 2) identify their social network (SN) members and map their SNs (network diagnostics); 3) engage key SN members to address their goals and needs (network engagement); 4) build channels for communication and collaboration with key SN members via in-person and virtual activities (opportunity creation); 5) communicate effectively with their key SN members, develop action plans, and provide support (skill building); and 6) engage in cycles of feedback to effectively respond to the patient's evolving needs.

Study Details

This is a pilot randomized controlled trial to assess the feasibility, acceptability, appropriateness, and structure of the SONATA intervention. In addition, it will assess the preliminary efficacy of SONATA compared to enhanced usual care among 70 older adults with advanced cancer.

Key Dates

Start date
Apr 10, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: SONATA Intervention
    Following randomization, patients assigned to SONATA will participate in up to six coaching sessions, delivered either in person or via Zoom over approximately six weeks.
  • No Intervention: Enhanced Usual Care
    Patients randomized to enhanced usual care will receive standard educational materials within 4 weeks of randomization.

Primary Outcome Measure

Study feasibility [ Time Frame: From baseline to week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642-

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By research site
University of Rochester· Rochester, NY

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