Long-term Follow-up of RESTORE Study

Blue Note Therapeutics

Status: Invitation-only

Conditions: Cancer

Treatments: Device: Long-term follow-up of cerena™; Device: Long-term follow-up of attune™

Study type: Observational

Funder types: Industry

Identifiers

NCT05647785

PROT005

Details and patient eligibility

About

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Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate.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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Enrolled in and not withdrawn from the original RESTORE study

Trial design

350 participants in 2 patient groups

cerena™

Description:

Subjects who took part in the cerena™ group during the original RESTORE study

Treatment:

Device: Long-term follow-up of cerena™

attune™

Description:

Subjects who took part in the attune™ group during the original RESTORE study

Treatment:

Device: Long-term follow-up of attune™