Cancer
Conditions
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 Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate.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.
Interventions
DEVICELong-term follow-up of cerena™
Long term follow-up for eligible participants from the RESTORE study
DEVICELong-term follow-up of attune™
Long term follow-up for eligible participants from the RESTORE study
Sponsors
Blue Note Therapeutics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrolled in and not withdrawn from the original RESTORE study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Healthcare utilization - hospitalizations | 3 and 6 months post RESTORE end-of-study | Length of hospitalizations in days (higher indicates greater healthcare utilization) |
| Healthcare utilization - medications | 3 and 6 months post RESTORE end-of-study | Number of medications (higher indicates greater healthcare utilization) |
| Healthcare utilization - claims and costs | 3 and 6 months post RESTORE end-of-study | Number of healthcare claims and associated costs (higher indicates greater healthcare utilization) |
| Fear of cancer recurrence | 3 and 6 months post RESTORE end-of-study | 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). |
| Healthcare utilization - visits and admissions | 3 and 6 months post RESTORE end-of-study | Number of visits and admissions (higher indicates greater healthcare utilization) |
Countries
United States
Outcome results
None listed