Long-term Follow-up of RESTORE Study

NCT05647785 | Unknown FDA Device

• 1 other identifier: PROT005
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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 Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate.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

Outcome Measures

Primary Outcomes (1)

• Symptoms of anxiety

  The PROMIS-Anxiety (PROMIS-A) is a validated PRO consisting of 8 questions measuring anxiety symptoms. The change in PROMIS-A score over time will be assessed (reduction indicates reduced anxiety).

  3 and 6 months post RESTORE end-of-study

Secondary Outcomes (8)

• Symptoms of depression

  3 and 6 months post RESTORE end-of-study

• Symptoms of emotional distress

  3 and 6 months post RESTORE end-of-study

• Cancer-related symptoms of anxiety (intrusions)

  3 and 6 months post RESTORE end-of-study

• Wellbeing and quality of life

  3 and 6 months post RESTORE end-of-study

• Stress management/coping skills

  3 and 6 months post RESTORE end-of-study

Other Outcomes (5)

• Fear of cancer recurrence

  3 and 6 months post RESTORE end-of-study

• Healthcare utilization - visits and admissions

  3 and 6 months post RESTORE end-of-study

• Healthcare utilization - hospitalizations

  3 and 6 months post RESTORE end-of-study

Study Arms (2)

cerena™

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

Device: Long-term follow-up of cerena™

attune™

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

Device: Long-term follow-up of attune™

Interventions

Long-term follow-up of cerena™ DEVICE

Long term follow-up for eligible participants from the RESTORE study

cerena™

Long-term follow-up of attune™ DEVICE

Long term follow-up for eligible participants from the RESTORE study

attune™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of all interested patients who were enrolled and not withdrawn from the parent study (RESTORE).

You may qualify if:

• Enrolled in and not withdrawn from the original RESTORE study

Sponsors & Collaborators

• Blue Note Therapeutics: lead

Study Sites (1)

Blue Note Therapeutics

San Francisco, California, 94104, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Dianne M Shumay, PhD

  Blue Note Therapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 12, 2022
• Study Start: October 31, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

US (1)