Long-term Follow-up of RESTORE Study

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05647785
• Other study ID #: PROT005
• Status: Enrolling by invitation
• Start date: October 31, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2022
• Source: Blue Note Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate.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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 350
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrolled in and not withdrawn from the original RESTORE study

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Long-term follow-up of cerena™
Long term follow-up for eligible participants from the RESTORE study
• Long-term follow-up of attune™
Long term follow-up for eligible participants from the RESTORE study

Locations

Country	Name	City	State
United States	Blue Note Therapeutics	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Blue Note Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Healthcare utilization - visits and admissions	Number of visits and admissions (higher indicates greater healthcare utilization)	3 and 6 months post RESTORE end-of-study
Other	Healthcare utilization - hospitalizations	Length of hospitalizations in days (higher indicates greater healthcare utilization)	3 and 6 months post RESTORE end-of-study
Other	Healthcare utilization - medications	Number of medications (higher indicates greater healthcare utilization)	3 and 6 months post RESTORE end-of-study
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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