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NCT Number: NCT07393529

A Pilot Randomized Controlled Trial of a Social Network Intervention

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

Location status: Recruiting

About this study

Older adults (aged ≥65) with advanced cancer are living longer due to more effective treatments, but their median survival remains around one year. We have shown that this population experiences a high prevalence of aging-related conditions, including functional and cognitive impairments, as well as depressive and anxiety symptoms. These conditions heighten their vulnerability to treatment toxicities and increase their need for assistance with daily activities. Together, these challenges impair older adults' ability to manage their care (patient activation) and reduce their overall quality of life (QoL). Therefore, interventions are needed to increase patient activation and improve QoL in this vulnerable population.

Fostering supportive social networks (SNs) can help older adults navigate the burden of cancer and its treatments. SNs comprise individuals (e.g., family members and friends) connected by interpersonal relationships. SN members offer a range of support, including instrumental, emotional, and informational support. They play pivotal roles in clinical settings, particularly for older individuals with functional impairments. SN members attend clinic visits and advocate for patients, ensuring accurate exchange and filtering of information to align with patients' preferences. SN members also shape patients' identities, coping strategies, and disease understanding. The role of SNs becomes more prominent as older adults become more ill.

The SOcial Networks to Activate Teamwork & Alliance (SONATA) intervention was designed to harness the SNs to provide support to older adults with advanced cancer and increase patient activation and improve QoL. The objective of this study is to conduct a pilot randomized controlled trial assessing SONATA compared to enhanced usual care among 70 older adults with advanced cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients

Inclusion criteria

  • Age ≥65 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

  • Any psychiatric or cognitive impairments interfering with participation as determined by the oncology team
  • Unwilling to complete study procedures

Social Network Members (if available, for intervention arm only)

Inclusion criteria

  • Age ≥18 years
  • Identified as an SN member by the patient in the intervention arm
  • Able to speak English
  • Able to provide informed consent

Exclusion criteria

  • Unwilling to complete study procedures

Treatment and study plan

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.

Primary outcomes

  1. Study feasibility

    Time frame: From baseline to week 16

    Retention rate. Percentage of patients who complete at least three SONATA sessions and week 16 post-intervention assessments

Secondary outcomes

  1. Emotional, social, and existential quality of life

    Time frame: From baseline to week 16

    14-item McGill QoL Questionnaire-Revised. A 14-item survey assessing quality of life. It has four subscales: Physical, Psychological, Existential, and Social. We will focus on Psychological, Existential, and Social subscales. Mean scores range from 0 to 10, higher scores are better

  2. Patient Activation

    Time frame: From baseline to week 16.

    Patient Activation Measure. A 13-item survey to assess patient knowledge, skill, and confidence for self-management. Total scores range from 0 to 100, higher scores are better.

  3. Autonomy, Competence, and Relatedness

    Time frame: From baseline to week 16

    Basic Psychological Need Satisfaction Scale. A 21-item survey to assess the degree to which people feel satisfaction of these three needs - autonomy, competence, and connectedness. Total scores range fom 21 to 147, higher scores are better.

  4. Social Support

    Time frame: From baseline to week 16

    Medical Outcomes Study-Social Support Survey. A 19-item survey to assess four domains of emotional/informational support, instrumental support, positive social interaction, and affection. Total scores range from 0-100, higher scores are better.

Study contacts

Contact information is provided by the study sponsor or research team.

Becky Gravenstede

CONTACT

[email protected]

585-727-4728

Kah Poh Loh

CONTACT

[email protected]

585-276-4353

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

A Pilot Randomized Controlled Trial of a Social Network Intervention for Older Patients With Cancer

Acronym: SONATA 2

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 6, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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