Trial Title:
Evaluation of a Personalised Survivorship Care Plan App for Patients with Melanoma
NCT ID:
NCT06643286
Condition:
Melanoma (Skin)
Melanoma, Stage II, Stage I
Melanoma Stage
Survivorship
Conditions: Official terms:
Melanoma
Conditions: Keywords:
Survivorship care
Application
RCT
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Multicentre randomized controlled trial, in which participants are randomised to either
the intervention group (use of the intervention in addtion to care usual) or the control
group (solely care as usual).
Primary purpose:
Supportive Care
Masking:
Double (Care Provider, Outcomes Assessor)
Masking description:
Care as usual is not altered in both study groups, as to where the care providers
continue to deliver the same care. As they are unaware of availability of the
intervention, the degree of information provision is not compromised.
During quantitative analyses we pursue masking the outcomes assessor(s).
Intervention:
Intervention type:
Device
Intervention name:
Digizorg Melanoma app
Description:
The 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.
Arm group label:
Intervention group
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years or older
- Patients who have received a primary diagnosis of cutaneous melanoma stage I to II
in the past 0-4 months
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Albert Schweitzer hospital
Address:
City:
Dordrecht
Zip:
3318 AT
Country:
Netherlands
Contact:
Last name:
Peter Plaisier, PhD
Email:
p.w.plaisier@asz.nl
Contact backup:
Last name:
Peter Plaisier, PhD
Facility:
Name:
Franciscus Gasthuis & Vlietland hospital
Address:
City:
Rotterdam
Zip:
3045 PM
Country:
Netherlands
Contact:
Last name:
Frederique Beverdam, PhD
Email:
f.beverdam@franciscus.nl
Contact backup:
Last name:
Frederique Beverdam, PhD
Facility:
Name:
Maasstad hospital
Address:
City:
Rotterdam
Zip:
3079 DZ
Country:
Netherlands
Contact:
Last name:
Kai Munte, MD
Email:
munteK@maasstadziekenhuis.nl
Contact backup:
Last name:
Kai Munte, MD
Start date:
November 1, 2024
Completion date:
March 1, 2026
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
BeterKeten
Agency class:
Other
Collaborator:
Agency:
Albert Schweitzer Hospital
Agency class:
Other
Collaborator:
Agency:
Maasstad Hospital
Agency class:
Other
Collaborator:
Agency:
Franciscus Gasthuis
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06643286
