Long-term Follow-up of RESTORE Study

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 Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate.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

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Device: Long-term follow-up of cerena™
* Device: Long-term follow-up of attune™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in and not withdrawn from the original RESTORE study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cerena™<br>Subjects who took part in the cerena™ group during the original RESTORE study | Device: Long-term follow-up of cerena™<br>* Long term follow-up for eligible participants from the RESTORE study<br>|
| attune™<br>Subjects who took part in the attune™ group during the original RESTORE study | Device: Long-term follow-up of attune™<br>* Long term follow-up for eligible participants from the RESTORE study<br>|

What is the study measuring?
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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 |