Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate.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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Long-term follow-up of attune™ | Device | — | UNRESOLVED |
| Long-term follow-up of cerena™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- cerena™
- description
- Subjects who took part in the cerena™ group during the original RESTORE study
- interventionNames
- Device: Long-term follow-up of cerena™
- label
- attune™
- description
- Subjects who took part in the attune™ group during the original RESTORE study
- interventionNames
- Device: Long-term follow-up of attune™
Primary outcomes (1)
- measure
- Symptoms of anxiety
- timeFrame
- 3 and 6 months post RESTORE end-of-study
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Enrolled in and not withdrawn from the original RESTORE study
References
Publications (0)
Data not yet available