Evaluation of a Personalised Survivorship Care Plan App for Patients With Melanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
A multicentre randomised controlled trial (RCT) will be conducted to evaluate the effectiveness of the digital personalised Melanoma Survivorship Care Plan (SCP) app. A total of hundred-eighty melanoma patients (stage I and II) will be randomised to receive either the SCP Melanoma app or usual care. The app provides survivors with personalized healthcare information on diagnosis, treatment and follow-up and supportive care, tailored to their melanoma stage and phase and information needs.Through questionnaires, medical file records, patient-reported outcomes and use of medical care will be evaluated. In addition, log-data, questionnaires and interviews will be used to evaluate the process of the uptake and implementation of the digital SCP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Patients who have received a primary diagnosis of cutaneous melanoma stage I to II in the past 0-4 months
Disqualifiers
Patients with irresectable stage III melanoma, patients receiving neo-adjuvant treatment and patients with stage IV melanoma.
Patients who do not have (sufficient) command of the Dutch language.
Trial design
Design model
Parallel
Treatments tested in this trial
Digizorg Melanoma app
DeviceThe Digizorg Melanoma app is a digital survivorship care plan, in which ellaborated information regarding diagnosis, treatment and follow-up and supportive care, adjusted to one's personal preferences and disease characteristics, is offered in the form of a mobile application.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Patient empowerment
The extent to which patients are able to cope with their own condition. This is a result of understanding by the patient of his/her role, acquisition by patients of sufficient knowledge to be able to engage with their healthcare provider, the skills of the patient skills and the presence of a facilitating environment. This outcome is measured through a scaled questionnaire (Health Education Impact Questionnaire), on which higher scores indicate a more health-conscious, self-monitored and empowered self.
Time frame
1 year after inclusionSecondary outcomes
1
Medical care consumption
The amount of (additional) contact moments (including telephone consultations) with medical specialists, nursing specialists and assistant physicians in the hospital, on top of care as usual.This outcome is measured in volumina through a questionnaire (iMTA Medical Consumption Questionnaire) and medical file research.
Time frame
1 year after inclusion2
Costs
All medical costs, related to healthcare utilization, and non-medical costs, related to productivity loss and implementation of the application. This outcome is calculated through the volumes of medical care consumption and productivity loss.
Time frame
1 year after inclusion3
Satisfaction with care
Overall subjective assessment of the received care around melanoma. This outcome is measured through one scaled question of a questionnaire (EORTC Outpatient satisfaction 7-items), of which lower scores indicate less satisfaction with care.
Time frame
1 year after inclusion4
Fear of recurrence
The extent of worries and fears surrounding cancer in oncology patients. This outcome is measured through a questionnaire (Cancer Worry Scale). Higher scores indicate more distress around cancer recurrences.
Time frame
1 year after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
BeterKeten
Collaborator
Albert Schweitzer Hospital
Collaborator
Maasstad Hospital
Collaborator
Franciscus Gasthuis
Collaborator
Source ClinicalTrials.gov