Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643286
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Evaluation of a Personalised Survivorship Care Plan App for Patients with Melanoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Personalised Survivorship Care for Patients with Melanoma a Multicenter Randomised Controlled Trial of the Survivorship Care Plan App
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Melanoma SCP
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 needsThrough 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None