Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID07393529

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

Led by University of Rochester · Updated on 2026-04-15

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Rochester

Lead Sponsor

A

American Cancer Society, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the SONATA intervention in a pilot randomized controlled trial involving 70 older adults aged 65 and older with advanced cancer. The study aims to assess the feasibility, acceptability, and structure of SONATA, a social network-based program designed to improve patient activation and quality of life for this vulnerable population facing functional and cognitive challenges, as well as depressive and anxiety symptoms. This intervention is compared to enhanced usual care to see preliminary effects. The SONATA intervention consists of up to six coaching sessions delivered either in person or via Zoom over about six weeks. These sessions help patients set personal well-being goals, identify and map their social networks, engage key members, create communication channels, build communication skills, and respond to their changing needs. The control group receives standard educational materials within four weeks of randomization. Participants will be involved from baseline through week 16, during which researchers will assess study feasibility along with emotional, social, and existential quality of life, patient activation, autonomy, competence, relatedness, and social support. The study includes monitoring patient responses and feedback throughout the intervention period. The total participation time extends to about 16 weeks, covering treatment and follow-up assessments to evaluate the intervention's impact.

CONDITIONS

Brief Title

A Pilot Randomized Controlled Trial of a Social Network Intervention

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Diagnosis of advanced or likely incurable cancer confirmed by primary oncologist
  • Able to speak English
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Psychiatric or cognitive impairments interfering with participation as determined by oncology team
  • Unwillingness to complete study procedures
  • For social network members only: unwillingness to complete study procedures if participating in intervention arm only

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) to assess eligibility

Treatment

Duration - Approximately 6 weeks

Participants randomized to the SONATA intervention participate in up to six coaching sessions, delivered either in person or via Zoom, focusing on social network engagement and patient activation. Participants in enhanced usual care receive standard educational materials.

Up to 6 coaching sessions (in-person or virtual) over 6 weeks or 1 educational session within 4 weeks

Follow-up

Duration - Up to 16 weeks from baseline

Participants are observed for study feasibility, quality of life, and patient activation outcomes from baseline through week 16 after starting the intervention.

Assessments at baseline and follow-up visits up to week 16

Trial Site Locations

Total: 1 location

1

University of Rochester

Rochester, New York, United States, 14642

Actively Recruiting

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Research Team

K

Kah Poh Loh

B

Becky Gravenstede

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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