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

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Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate.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

Study Overview

• Status: Enrolling by invitation
• Conditions: Cancer
• Intervention / Treatment: Device: Long-term follow-up of cerena™; Device: Long-term follow-up of attune™

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94104
      • Blue Note Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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The study population will consist of all interested patients who were enrolled and not withdrawn from the parent study (RESTORE).

Description

Inclusion Criteria:

• Enrolled in and not withdrawn from the original RESTORE study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cerena™; Subjects who took part in the cerena™ group during the original RESTORE study	Device: Long-term follow-up of cerena™; Long term follow-up for eligible participants from the RESTORE study
attune™; Subjects who took part in the attune™ group during the original RESTORE study	Device: Long-term follow-up of attune™; Long term follow-up for eligible participants from the RESTORE study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of depression	The PROMIS-Depression (PROMIS-D) is a validated PRO consisting of 8 questions measuring depression symptoms. The change in PROMIS-D score over time will be assessed (decrease indicates reduced depression).	3 and 6 months post RESTORE end-of-study
Symptoms of emotional distress	Change in PROMIS Emotional Distress; a composite of PROMIS-Anxiety and PROMIS-Depression over time (decrease indicates reduced emotional distress).	3 and 6 months post RESTORE end-of-study
Cancer-related symptoms of anxiety (intrusions)	The Impact of Events Scale-Revised (IES-R) is used to assess subjective distress caused by a stressful life event, which in this study is cancer. The change in the IES-R Intrusion subscale score over time will be assessed (decrease indicates reduced intrusive symptoms related to cancer).	3 and 6 months post RESTORE end-of-study
Wellbeing and quality of life	The Functional Assessment of Cancer Therapy - General (FACT-G) is designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. The change in FACT-G scores over time will be assessed (increase indicates improved quality of life).	3 and 6 months post RESTORE end-of-study
Stress management/coping skills	The Measure of Current Status (MOCS) Part A measures self-perceived status for using coping skills. The change in MOCS Part A scores over time will be assessed (increase indicates greater confidence in skill use ability).	3 and 6 months post RESTORE end-of-study
Non-specific (social) intervention effects	The Measure of Current Status (MOCS) Part B assesses non-specific intervention effects - feelings of normalcy vs. alienation, sense of cohesiveness with other patients, perceptions of care from persons around them, and a sense of being better off than other cancer patients. The change in MOCS Part B scores over time will be assessed (increase indicates greater non-specific intervention effects).	3 and 6 months post RESTORE end-of-study
Perceived stress	The Perceived Stress Scale (PSS) measures how different situations affect feelings and perceived stress. The change in PSS scores over time will be assessed (higher PSS scores indicate higher perceived stress).	3 and 6 months post RESTORE end-of-study
Benefit finding	The 17-item Benefit Finding Scale measures the perception that positive contributions were made to one's life by the experience of being diagnosed with and treated for cancer. Change in scores over time will be assessed (increase indicates increase in benefit finding).	3 and 6 months post RESTORE end-of-study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of cancer recurrence	The Fear of Cancer Recurrence Inventory - Short Form and the Fear of Cancer Recurrence single item measure assess the fear of cancer returning or progressing (higher scores indicate greater fear of cancer recurrence).	3 and 6 months post RESTORE end-of-study
Healthcare utilization - visits and admissions	Number of visits and admissions (higher indicates greater healthcare utilization)	3 and 6 months post RESTORE end-of-study
Healthcare utilization - hospitalizations	Length of hospitalizations in days (higher indicates greater healthcare utilization)	3 and 6 months post RESTORE end-of-study
Healthcare utilization - medications	Number of medications (higher indicates greater healthcare utilization)	3 and 6 months post RESTORE end-of-study
Healthcare utilization - claims and costs	Number of healthcare claims and associated costs (higher indicates greater healthcare utilization)	3 and 6 months post RESTORE end-of-study

Collaborators and Investigators

• Sponsor: Blue Note Therapeutics
• Investigators: Principal Investigator: Dianne M Shumay, PhD, Blue Note Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PROT005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No