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Trial Title:
Long-term Follow-up of RESTORE Study
NCT ID:
NCT05647785
Condition:
Cancer
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Long-term follow-up of cerena™
Description:
Long term follow-up for eligible participants from the RESTORE study
Arm group label:
cerena™
Intervention type:
Device
Intervention name:
Long-term follow-up of attune™
Description:
Long term follow-up for eligible participants from the RESTORE study
Arm group label:
attune™
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Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible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.
Criteria for eligibility:
Study pop:
The study population will consist of all interested patients who were enrolled and not
withdrawn from the parent study (RESTORE).
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Enrolled in and not withdrawn from the original RESTORE study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Blue Note Therapeutics
Address:
City:
San Francisco
Zip:
94104
Country:
United States
Start date:
October 31, 2022
Completion date:
June 30, 2023
Lead sponsor:
Agency:
Blue Note Therapeutics
Agency class:
Industry
Source:
Blue Note Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05647785
