NCT05647785

Long-term Follow-up of RESTORE Study

Extension Study to Compare Long-term Efficacy of Two Digital Software Medical Devices as Interventions for Physical and Mental Health in Cancer Patients Previously Enrolled in the RESTORE Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Blue Note Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The RESTORE extension study is a non-interventional, long-term follow-up study with people who participated in the study referred to as RESTORE (NCT05227898). The purpose of this extension study is to understand the durability of the effects of two digital software devices on anxiety and other indicators of psychological and physical health in participants of the RESTORE study in the 6-months after study completion. Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate. People who consent to participate will be asked to electronically complete a set of questionnaires at 3 months and 6 months following the scheduled date of their RESTORE end-of-study visit.

Conditions

• Cancer

Interventions

Type	Name	Description
DEVICE	Long-term follow-up of cerena™	Long term follow-up for eligible participants from the RESTORE study
DEVICE	Long-term follow-up of attune™	Long term follow-up for eligible participants from the RESTORE study

Timeline

• Start date: 2022-10-31
• Primary completion: 2023-05-31
• Completion: 2023-06-30
• First posted: 2022-12-12
• Last updated: 2022-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study