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CLEOPATRA: Identification of recovery trajectories with a digital resilience assessment tool.

CLEOPATRA: Identification of recovery trajectories with a digital resilience assessment tool. - CLEOPATRA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57437
Enrollment
120
Registered
2024-11-14
Start date
2025-09-25
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Cancer

Interventions

The digital resilience tool, in the IMDD referred to as “Orion” application, is developed by Orikami (Nijmegen, the Netherlands), intended to support the monitoring of older patients before, after, an
other built-in features such as GPS and physiological measurements will be deactivated at baseline. 2. Cognitive processing speed (number of correct answers on a smartphone variant of the symbol digit

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 60 years and older, having cancer, intention or ongoing treatment for any solid malignant  tumor with systemic treatment, either chemotherapy, immunotherapy, target  therapy, or combinations. - 50 years and older, intention or ongoing treatment for stage IV lung cancer with a systemic  treatment, either chemotherapy, immunotherapy, targeted therapy, or  combinations. - Written informed consent - Access to personal smartphone (iOS 14+ or Android 9+), willingness to have  the Orion app installed and able to navigate the app (with assistance if  needed).

Exclusion criteria

Exclusion criteria: - Participants who do not speak Dutch - Participants with inability to perform the tests within the digital resilience tool (blind, unable to walk or stand safely/independently, unable to navigate the app sufficiently and if necessary, with help, as assessed by the researcher after training) - Other reason the treating physician or researcher would deem inclusion in this study unsafe or unnecessarily burdensome.

Design outcomes

Secondary

MeasureTime frame
1. The (alternative form) test-retest reliability, concurrent validity, and discriminant (divergent) validity. 2. Determine how different recovery trajectories are related to clinical outcomes. 3. Adherence rates of using the digital resilience tool and the Garmin wearable device during systemic anticancer treatment and feedback on user experience. 4. To investigate whether the recovery trajectory can be predicted from baseline data and early improvements or changes (<3 months) in functional status measured with the Orion application and the Garmin wearable device.

Primary

MeasureTime frame
The main study parameters include the repeated measurements of the Orion application and the Garmin wearable device. These consist of:Longitudinal neuro-cognitive measurements from the digital symbol digit modality test (SDMT) and the digital spatial recall test (SPART)Longitudinal physical measurements of daily physical activity (step count) via the Garmin wearable device.Short EMA questionnaires (ecological momentary assessments) containing momentary questions about pain, fatigue and wellbeing.

Countries

Netherlands

Contacts

Public ContactF. Bos

Leids Universitair Medisch Centrum

f.van_den_bos@lumc.nl071-5264476

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 28, 2026