Evaluation of a Personalised Survivorship Care Plan App for Patients With Melanoma (Melanoma SCP)

Personalised Survivorship Care for Patients With Melanoma: A Multicenter Randomised Controlled Trial of the Survivorship Care Plan App

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma (Skin); Survivorship; Melanoma Stage; Melanoma, Stage II, Stage I
• Intervention / Treatment: Device: Digizorg Melanoma app

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marjolein Lugtenberg, PhD; Phone Number: +31614448940; Email: m.lugtenberg@erasmusmc.nl
• Study Contact Backup: Name: June Kievits, MD; Email: j.kievits@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Dordrecht, Zuid-Holland, Netherlands, 3318 AT
      • Recruiting
      • Albert Schweitzer Hospital
      • Contact: Peter Plaisier, PhD; Email: p.w.plaisier@asz.nl
      • Principal Investigator: Peter Plaisier, PhD
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus MC
      • Contact: Marjolein Lugtenberg, PhD; Phone Number: +316 144488940; Email: m.lugtenberg@erasmusmc.nl
      • Principal Investigator: Marjolein Lugtenberg, PhD
    • Rotterdam, Zuid-Holland, Netherlands, 3079 DZ
      • Recruiting
      • Maasstad Hospital
      • Contact: Kai Munte, MD; Email: munteK@maasstadziekenhuis.nl
      • Principal Investigator: Kai Munte, MD
    • Rotterdam, Zuid-Holland, Netherlands, 3045 PM
      • Not yet recruiting
      • Franciscus Gasthuis & Vlietland hospital
      • Contact: Frederique Beverdam, PhD; Email: f.beverdam@franciscus.nl
      • Principal Investigator: Frederique Beverdam, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants receive access to the Digizorg Melanoma app, on top of care as usual.	Device: Digizorg Melanoma app; 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.
No Intervention: Control group; Participants have access to care as usual, but have no access to the Digizorg Melanoma app and its functionalities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year after inclusion
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.	1 year after inclusion
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.	1 year after inclusion
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.	1 year after inclusion
Coping style	The thoughts and behaviors mobilized to manage internal and external stressful situations. This outcome is measured through a questionnaire (shortened Threatening Medical Situations Inventory), in which two hypothetical situations and resulting actions are assessed and scored.	At baseline
Productivity loss	The extent to which the person's ability to perform his/her work is affected as a result of the disease. This outcome is measured in volumina through a questionnaire (iMTA productivity cost questionnaire).	1 year after inclusion
Satisfaction with information	The extent and quality to which patients feel informed, specifically during treatment for melanoma. This outcome is measured through a questionnaire (EORT Core Quality of Life Questionnaire Information module 25-items), by which self-report can express high satisfaction with information (high scores) to low satisfaction (low scores).	1 year after inclusion
Need for supportive care	The individual needs of the patient for care, upon which targeted supportive care can then be provided. This outcome is measured through a questionnaire (Supportive Care Needs Survey - Short form 34-items), exposing different areas for needs through distinguishment of the level of satisfaction and need for care.	1 year after inclusion

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Albert Schweitzer Hospital; Franciscus Gasthuis; Maasstad Hospital; BeterKeten

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: RCT; Application; Survivorship care
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma
• Other Study ID Numbers: 10147 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No