SONATA Intervention for Cancer

(SONATA 2 Trial)

KP
BG
Overseen ByBecky Gravenstede
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an approach called SONATA to determine if it helps older adults with advanced cancer manage their condition more effectively. Participants will either receive the SONATA intervention, which includes up to six coaching sessions, or the usual educational materials. The goal is to assess whether SONATA is user-friendly and impacts care. Suitable participants have advanced cancer and can speak English. As an unphased trial, this study provides a unique opportunity to contribute to innovative cancer care strategies.

Do I need to stop my current medications for the SONATA trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the SONATA intervention is safe for older adults with advanced cancer?

Research has shown that the SONATA program for cancer is under study for its potential benefits. Although direct studies on its safety for cancer are limited, one study found the SONATA program safe and effective for treating fibroid symptoms. This finding suggests it might also be safe for cancer care.

The SONATA program includes coaching sessions to support patients through social networks. As it doesn't involve medication or surgery, it may pose fewer risks than typical cancer treatments. However, since this is a new method, researchers continue to gather information on its safety and effectiveness for cancer care.12345

Why are researchers excited about this trial?

Researchers are excited about the SONATA intervention because it offers a novel approach to cancer care through personalized coaching sessions. Unlike traditional treatments that primarily focus on medical procedures or medication, SONATA emphasizes behavioral support, potentially enhancing patient well-being and engagement with their care plan. Delivered flexibly in person or over Zoom, this method could make cancer treatment more accessible and personalized, addressing both physical and emotional aspects of the condition.

What evidence suggests that the SONATA intervention might be an effective treatment for advanced cancer?

Research has shown that strong social connections can positively affect cancer care. In this trial, participants will be randomized into one of two groups: the SONATA Intervention group or the Enhanced Usual Care group. The SONATA program offers coaching to help build these connections, potentially improving outcomes for cancer patients. Although specific data on SONATA's effectiveness is limited, studies indicate that support can lead to better health and well-being. This program aims to provide both emotional and practical support, which is crucial for patients dealing with advanced cancer. Early results suggest that such support can significantly impact patient care.12456

Who Is on the Research Team?

KP

Kah Poh Loh

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for English-speaking older adults aged 65 or above with advanced cancer that's likely incurable. Participants must be able to give informed consent.

Inclusion Criteria

I can understand and agree to the study's details.
Patients
I am 65 years old or older.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization

Participants are randomized to either the SONATA intervention or enhanced usual care

1 week

SONATA Intervention

Participants in the SONATA group receive up to six coaching sessions over approximately six weeks

6 weeks
Up to 6 visits (in-person or via Zoom)

Enhanced Usual Care

Participants receive standard educational materials within 4 weeks of randomization

4 weeks

Follow-up

Participants are monitored for retention and quality of life measures

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SONATA

Trial Overview

The SONATA intervention, a social network support system, is being tested against enhanced usual care in elderly patients with advanced cancer to see if it's feasible and helpful.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: SONATA InterventionExperimental Treatment1 Intervention
Group II: Enhanced Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

American Cancer Society, Inc.

Collaborator

Trials
237
Recruited
110,000+

Citations

A Single Arm Pilot Trial of a Social Network Intervention

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 ...

Social Network Coaching for Cancer - (SONATA Trial)

Although direct data on SONATA's effectiveness is limited, evidence indicates that social networks can positively impact cancer care. The program uses coaching ...

12-month outcomes of the US patient cohort in the SONATA ...

Treatment with the Sonata system resulted in significant improvements in all patient-reported outcomes, beginning with the 3-month visit (the first post- ...

SONATA - Transforming Ovarian cancer diagnostic ...

The SONATA project aims to improve the early detection of ovarian cancer by evaluating the use of the Risk of Ovarian Malignancy Algorithm (ROMA) in primary and ...

SONATA Intervention for Cancer (SONATA 2 Trial)

This is a pilot randomized controlled trial to assess the feasibility, acceptability, appropriateness, and structure of the SONATA intervention.

A Pilot Randomized Controlled Trial of a Social Network ...

The objective of this study is to conduct a pilot randomized controlled trial assessing SONATA compared to enhanced usual care among 70 older ...