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

NCT06643286 | Recruiting

• 1 other identifier: 10147
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

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.

Conditions

Melanoma (Skin); Melanoma, Stage II, Stage I; Melanoma Stage; Survivorship

Keywords

Survivorship care; Application; RCT

Outcome Measures

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.

  1 year after inclusion

Secondary Outcomes (8)

• Medical care consumption

  1 year after inclusion

• Costs

  1 year after inclusion

• Satisfaction with care

  1 year after inclusion

• Fear of recurrence

  1 year after inclusion

• Coping style

  At baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receive access to the Digizorg Melanoma app, on top of care as usual.

Device: Digizorg Melanoma app

Control group

NO INTERVENTION

Participants have access to care as usual, but have no access to the Digizorg Melanoma app and its functionalities.

Interventions

Digizorg Melanoma app DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Patients who have received a primary diagnosis of cutaneous melanoma stage I to II in the past 0-4 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• BeterKeten: collaborator
• Albert Schweitzer Hospital: collaborator
• Maasstad Hospital: collaborator
• Franciscus Gasthuis: collaborator

Study Sites (4)

Albert Schweitzer hospital

Dordrecht, South Holland, 3318 AT, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Franciscus Gasthuis & Vlietland hospital

Rotterdam, South Holland, 3045 PM, Netherlands

NOT YET RECRUITING

Maasstad hospital

Rotterdam, South Holland, 3079 DZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Marjolein Lugtenberg, PhD

CONTACT

+31614448940; m.lugtenberg@erasmusmc.nl

June Kievits, MD

CONTACT

j.kievits@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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).

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 16, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-04

Locations

NL (4)