The growing and diverse group of survivors of stage I and II melanoma leads to an
increasing need for patient-tailored survivorship care. To meet these needs, the
Survivorship Care Plan (SCP) app ('Digizorg Melanoma app') was developed together with
patients and healthcare providers, providing patients with melanoma with personalised
information on diagnosis, treatment and follow-up and supportive care. The aim of this
study is to evaluate the effectiveness of the Digizorg Melanoma SCP app in terms of
patient and provider-reported outcomes and clinical practice.
A multicenter randomized controlled trial (RCT) will be performed in four Dutch
hospitals, namely Erasmus MC, Albert Schweitzer hospital, Maasstad hospital and
Franciscus Gasthuis & Vlietland. A total of 180 patients (stage I and II) will be
randomized to receive either the 'SCP-app' or 'usual care'. Patients are included within
0-4 months of primary diagnosis. If patients are diagnosed with stage III or IV, they are
excluded. The app consists of information tailored to survivors' melanoma stage and phase
as well as their information needs. Participants receive questionnaires at baseline, and
at 6 and 12 months. Additionally, medical records are examined for healthcare use. The
primary outcome is patient empowerment. Secondary outcomes are satisfaction with
information and care, fear of (return of) cancer, needs for supportive care, coping style
and healthcare use. Additionally, a process evaluation will be conducted to gain insight
into the uptake and evaluation of (the implementation of) the intervention by users.
To evaluate the effectiveness of the Digizorg Melanoma app (effect evaluation), scores on
outcome measures will be compared between the two study groups through questionnaires and
medical file records analysis, correcting for baseline scores. The primary outcome
measure is patient empowerment. Secondary outcome measures are medical care consumption,
costs, fear of (return of) cancer, need for supportive care, coping style and
satisfaction with information and care. All outcome measures are measured in both groups
in the form of questionnaires at the start of the trial (T0) and 6 (T1) and 12 months
(T2) after inclusion. Medical file records (number of healthare appointment records in
the file) will only be assessed at the start of the trial (T0) and after 12 months (T2).
To gain insight into the uptake and evaluation of (the implementation of) the
intervention (process evaluation), (log) data on the use of the app will be analysed,
short satisfaction questionnaires will be administered twice to patients and up to 30
short-term interviews with patients and other stakeholders (including healthcare
providers, IT specialists and developers) will be conducted to explore satisfaction with
app, impact on coordination and suggestions for improvement.
There are no specific risks associated with participating in this study. Participants
will have the opportunity to use the app with personalised information on diagnosis,
treatment and follow-up and supportive care. However, no specific actions are imposed and
the care participants receive remains the same. Participation in the study does require a
time investment from patients in the form of completing questionnaires three times over a
year. However, the time investment will be limited to 30-45 minutes each time. In
addition, the number of questions that can be perceived as burdensome by patients is
limited. A small proportion of patients will additionally be approached for a short-term
interview (of max 30 min) as part of the process evaluation.