Clinical trial NCT06643286: Evaluation of a Personalised Survivorship Care Plan App for Patients With Melanoma
Official title: Personalised Survivorship Care for Patients With Melanoma: A Multicenter Randomised Controlled Trial of the Survivorship Care Plan App
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma (Skin)
Melanoma, Stage II, Stage I
Melanoma Stage
Survivorship
Keywords: Survivorship care
Application
RCT
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: BeterKeten
name: Albert Schweitzer Hospital
name: Maasstad Hospital
name: Franciscus Gasthuis
First posted: 2024-10-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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.

Primary outcomes:
measure: Patient empowerment
timeFrame: 1 year after inclusion
Secondary outcomes:
measure: Medical care consumption
timeFrame: 1 year after inclusion
measure: Costs
timeFrame: 1 year after inclusion
measure: Satisfaction with care
timeFrame: 1 year after inclusion
measure: Fear of recurrence
timeFrame: 1 year after inclusion
measure: Coping style
timeFrame: At baseline
measure: Productivity loss
timeFrame: 1 year after inclusion
measure: Satisfaction with information
timeFrame: 1 year after inclusion
measure: Need for supportive care
timeFrame: 1 year after inclusion
Other outcomes:
Locations:
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer hospital
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland hospital
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad hospital
state: Zuid-Holland
Study officials:
References: