To compare health-related quality of life, specifically fatigue, in melanoma patients treated with immunotherapy who use or do not use a patient-centered mobile coaching and monitoring system (CAPABLE). We expect that by using the CAPABLE eHealth…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are the fatigue symptom scale of The European
Organization for Research and Treatment of Cancer Quality of Life
Questionnaire-core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 is a self-reported
questionnaire, specifically developed for patients with cancer who are
receiving cancer treatment. The EORTC-QLQ- C30 is widely accepted and validated
in clinical studies and is the most common quality of life instrument used in
melanoma studies.
Secondary outcome
Feasibility
• Recruitment rate: number of included patients relative to the number of
invited patients: recruitment rate will be calculated by the percentage of
included patients compared to the total number of eligible patients contacted.
An overall recruitment rate of 36 patients will be considered feasible.
• Patient compliance to the system will be evaluated by system interaction and
data from the CAPABLE operational logs:
o Users* interactions logs;
o Component interaction data;
o Recommendations and messages generated by the system for the clinician and
patient.
• Patient retainment: number of patients finishing the study: Patient
retainment will be calculated as the number of patients retained in the study
for the full first three months as a percentage of the number of patients who
started the study
Additional patient-reported outcomes (PROMs)
Secondary study parameters include outcomes of questionnaires regarding
health-related quality of life outcomes, anxiety and depression,
melanoma-specific HRQoL, immune-related adverse events and information needs in
high risk and advanced melanoma patients treated with immune
checkpoint-inhibitors.
* The EuroQoL-5D (EQ-5D-5L). The EQ-5D is a standardised 5-level, 5-dimensional
multi-attribute utility questionnaire that measures mobility, self-care, usual
activities, pain/discomfort and anxiety/depression, using a five dimension
scale. This questionnaire is currently being used in the hospital according to
clinical practice.
* Of the FACT-M, we use the Melanoma Subscale and the Melanoma Surgery
Subscale, items specific to quality of life in melanoma patients. High scores
show a high quality of life. Testing has shown that the FACT-M is a reliable
and valid instrument to assess quality of life in patients with melanoma. This
questionnaire is currently used in the hospital according to clinical practice.
* Psychological distress will be assessed with the Hospital Anxiety and
Depression Scale (HADS). The HADS, a 14-item questionnaire, assesses symptoms
of mood disturbance, yielding separate scale scores for anxiety and depression,
as well as a total score. Numerous studies have applied the HADS to assess
distress among cancer survivors and the questionnaire has been validated for
use in the Dutch population.
* Immunotherapy-specific questionnaire. In assessing quality of life in cancer
patients, it is recommended to use a generic and cancer-specific measure of
quality of life plus a treatment-specific questionnaire. However, to date the
available validated measurements do not include the problems and symptoms of
immunotherapy. Therefore, we identified, based on literature and expert
opinion, 19 symptoms and created a symptom list based on items of the EORTC
item Library [EORTC Item Library, qol.eortc.org/item-library].
* Fulfilment of information needs will be measured by the EORTC QLQ-INFO25
questionnaire. This validated 25-item questionnaire incorporates four
information provision subscales: perceived receipt of information about the
disease, medical tests, treatment and other care services.
Symptom monitoring
The severity of reported symptoms according to CTCAE v.5 grade. The number and
severity will be collected from the EHRs and the CAPABLE system.
Additional secondary parameters
For the secondary objectives, data collected during the study:
o Data from the physician web application:
* Patient details entered at the time of enrolment;
* Patient-specific settings (which Virtual Capsules are available for this
patient);
* Clinician*s responses to recommendations (accept or decline).
o Data from the patient app:
* Symptom reporting data;
* Patient*s selection of Virtual Capsules;
* Patient*s actions in the app and responses to prompts;
* Patient*s app preferences and settings;
o Sensor data collected using the ASUS smartwatch;
o From the EHR:
* Information on comorbidities
* Clinical data (disease, treatment details, adverse events);
* Medication prescriptions;
* Hospitalizations;
* Referrals to additional care;
Background summary
The most convincing data for web-based applications monitoring cancer patients,
exists on patients receiving chemotherapy and less is known about symptom
monitoring during immunotherapy. Melanoma patients treated with
immune-checkpoint inhibitors have extensive needs for supportive care,
information provision and symptom management, regardless of information and
services already provided by the hospital. Patients believe that the use of
eHealth applications, facilitating information gathering and symptom
management, would increase their self-management skills, which would contribute
to patients* autonomy. All of these were seen as positive drivers for quality
of life. Therefore, we believe that more research is needed to explore the use
and feasibility of eHealth applications in melanoma patients during
immunotherapy. One example is a system like CAPABLE to support, monitor and
coach cancer patients during systemic/ICIs treatment in order to maintain or
improve quality of life (functioning and fatigue).
Previous pilot studies only focused on eHealth interventions affecting symptom
monitoring. This study will introduce the more extensive CAPABLE eHealth tool:
a clinical decision support system (DSS) dedicated to patients and healthcare
professionals (HCPs). CAPABLE will support its users by providing
evidence-based recommendations that are extracted from clinical practice
guidelines and best practice knowledge, and formalised into computer
interpretable guidelines (CIGs).The CAPABLE system serves three main goals for
the patient: symptom monitoring, information needs fulfilment and interventions
to improve mental- and physical wellbeing. These are available to the patient
as a smartphone application that is connected to a smartwatch to monitor
activity, blood pressure, sleep and heart rate. The CAPABLE system is
accessible by healthcare professionals through a web application. They can
closely follow up the patient and have access to all patient-reported outcomes
and patient-generated data. The healthcare professionals involved in the
present study include oncologists, nurse practitioners, psychologists and
nutritionists. This study can therefore be considered as a first phase in
exploring the use and feasibility and acceptability of this eHealth tool in
melanoma patients treated with ICIs. Especially, in this study we will explore
the effect of using CAPABLE on HRQoL outcomes as fatigue, physical- and role
functioning, and patients* acceptability of using a system as CAPABLE.
Study objective
To compare health-related quality of life, specifically fatigue, in melanoma
patients treated with immunotherapy who use or do not use a patient-centered
mobile coaching and monitoring system (CAPABLE). We expect that by using the
CAPABLE eHealth tool, patients' fatigue worsens less significantly (10 points)
in the first 3 months of treatment than observed in usual care.
Study design
This is a prospectively enrolling, explorative cohort study in melanoma
patients, eligible for treatment with ICI therapy. The explorative cohort
receives the CAPABLE smartphone application and a multi-sensorial smartwatch.
Patients will be asked to use the system for minimum of three to maximum of six
months after enrolment. Figure 1 shows the timeline of the CAPABLE study.
Questionnaires will be administered to the patients on baseline (T0) and every
three months (T1 and T2). Quantitative user experience studies will be done at
3 months and at the end of the individual follow-up period with the CAPABLE
system (T3). Outcomes of this study will be the exploration of changes in the
health-related quality of life outcomes such as fatigue and physical- and role
functioning in melanoma patients when using an eHealth tool during ICIs.
Secondary, an explorative comparison with a historical cohort consisting of
melanoma patients (P20MEL; NL75996.031.20) with the same inclusion criteria as
this study population, but receiving standard care (e.g. without the CAPABLE
app) will be done.
Study burden and risks
An extensive risk analysis is done, and added in the attached Data Protection
Impact Assessment (DPIA). NKI*s Data Protection- and Security Officers approved
the DPIA. Usage of an eHealth tool that monitors symptoms, provides
information, and allows patients to work on their well-being from home can be
experienced positively. However, a patient might find it too confronting to use
the app after a while. Furthermore, it will take the patient time to fill in
research-related questionnaires (3 times 30 minutes) and using the CAPABLE app.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
* >18 years of age
* Sufficient understanding of the Dutch language
* Participants or their caregiver can use a smartphone (upon patient*s consent)
* Histologically confirmed melanoma (high-risk resectable stage III and stage
IV and unresectable stage III) patients indicated to receive treatment with
immune checkpoint-inhibitors, according to the clinical guidelines.
Exclusion criteria
Included in experimental clinical trial (with medication)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81970.000.22 |