Long-term Follow-up of RESTORE Study
- Conditions
- Cancer
- Interventions
- Device: Long-term follow-up of attune™Device: Long-term follow-up of cerena™
- Registration Number
- NCT05647785
- Lead Sponsor
- Blue Note Therapeutics
- 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Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate.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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 350
- Enrolled in and not withdrawn from the original RESTORE study
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description attune™ Long-term follow-up of attune™ Subjects who took part in the attune™ group during the original RESTORE study cerena™ Long-term follow-up of cerena™ Subjects who took part in the cerena™ group during the original RESTORE study
- Primary Outcome Measures
Name Time Method Symptoms of anxiety 3 and 6 months post RESTORE end-of-study 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).
- Secondary Outcome Measures
Name Time Method Symptoms of depression 3 and 6 months post RESTORE end-of-study 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).
Symptoms of emotional distress 3 and 6 months post RESTORE end-of-study Change in PROMIS Emotional Distress; a composite of PROMIS-Anxiety and PROMIS-Depression over time (decrease indicates reduced emotional distress).
Cancer-related symptoms of anxiety (intrusions) 3 and 6 months post RESTORE end-of-study 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).
Wellbeing and quality of life 3 and 6 months post RESTORE end-of-study 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).
Stress management/coping skills 3 and 6 months post RESTORE end-of-study 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).
Non-specific (social) intervention effects 3 and 6 months post RESTORE end-of-study 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).
Perceived stress 3 and 6 months post RESTORE end-of-study 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).
Benefit finding 3 and 6 months post RESTORE end-of-study 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).
Trial Locations
- Locations (1)
Blue Note Therapeutics
🇺🇸San Francisco, California, United States