The overall aim of this study is to identify and describe distinct recovery trajectories with the innovative digital resilience assessment tool (Orion) in older oncology patients and patients with stage IV lung cancer during systemic therapy.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters include the repeated measurements of the Orion
application. These consist of:
1. Longitudinal neuro-cognitive measurements from the digital symbol digit
modality test (SDMT) and the digital spatial recall test (SPART)
2. Longitudinal physical measurements from the digital 2-minute walk test
(2MWT) and digital timed-up-and-go test (TUG).
3. Short EMA questionnaires (ecological momentary assessments) containing
momentary questions about weight, pain, fatigue and wellbeing.
Secondary outcome
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 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.
Background summary
About 55% of people with cancer are 70 years or older. However, cancer
treatment in older patients is demanding, because of the underrepresentation of
older adults in clinical trials that inform treatment guidelines and due to the
increase of treatment toxicity with age. In older patients, treatment therefore
often results in therapy-related toxicity, treatment discontinuation, decreased
quality of life, functional decline, and increased hospital admissions.
Currently, frailty is an important aspect of the management of older patients
and is defined as a state of increased vulnerability resulting from an
aging-associated decline in reserve. While frailty as a concept is strong in
defining vulnerable patients who will have a difficult time maintaining
homeostasis after a stressor (like anticancer therapy), the concept of
resilience is broader and more dynamic and emphasizes the coping and recovery
potential after a stressor.
To help care teams objectively detect older patients* recovery potential to
adverse outcomes of intensive treatment, this project evaluates an easy-to-use
digital resilience self-monitoring solution in older cancer patients. The
resilience solution consists of a set of measurements in multiple domains (i.e.
cognition, mobility) using a patient*s smartphone. Home monitoring of
resilience, through longitudinal measurements, enables the detection of delayed
recovery or even an early functional positive response to therapy. Thereby
enabling timely interventions within specific domains. Additionally, early
prediction of recovery potential permits refined prognostication, shared
decision-making, and optimization of care.
Study objective
The overall aim of this study is to identify and describe distinct recovery
trajectories with the innovative digital resilience assessment tool (Orion) in
older oncology patients and patients with stage IV lung cancer during systemic
therapy.
Study design
In this prospective observational study, a group of patients with different
types of solid tumours are asked to use the Orion application while receiving
systemic anti-cancer treatment. Patients receive standard care. The results
from the tests in the Orion application will be plotted and distinct recovery
groups will be identified.
Study burden and risks
This research is firmly embedded in the routine outpatient clinical work-up in
all participating hospitals. After informed consent, participants will be asked
to attend one physical appointment for a short geriatric assessment, user
training of the app, and baseline measurements. This is estimated to take
between 30-60 minutes. A subsample of 37 participants will additionally be
recruited to complete the physical/paper-and-pencil equivalent tests used in
the Orion application during this appointment. This will approximately take an
additional 30 minutes. Participants will be asked to use the Orion application
at home (approximate time investment total 15-20 minutes per week) for 6
months. There are limited risks to using the Orion application, except for the
time burden associated with use. Completing cognitive tests in a clinical or
laboratory setting can sometimes be perceived as stressful, however, in this
study, participants can complete the tests at home using the Orion application
at a time that is convenient for them, apart from the first visit. Using this
Orion application has no impact on routine of care. There are no direct
benefits for participants while using the Orion application.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- 70 years and older, having cancer, intention to treat any solid malignant
tumor with systemic treatment, either chemotherapy, immunotherapy, target
therapy, or combinations.
- 60 years and older, intention to treat 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
- 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
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88338.000.24 |