The MELAcare Study: A New Method for Surveillance of Melanoma Patients
- Conditions
- Cutaneous Melanoma
- Interventions
- Other: The MelaCare intervention
- Registration Number
- NCT05253872
- Lead Sponsor
- Herlev and Gentofte Hospital
- Brief Summary
The aim of this study is to evaluate a new method of follow-up for patients with low and intermediate risk (stages IA-IIA) melanoma. The investigators will compare different tools for patient support and education combined with clinician supported skin self-examination (SSE) to the current standard-of-care. The hypothesis is that meta-cognitive strategies and clinician supported SSE can lower fear of cancer recurrence (FCR) and promote effective SSE on a regular basis without compromising the detection of new primary melanomas and/or metastases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 378
- Ability to read and understand Danish language
- Willing and able to give written informed consent
- Surgical treatment of a clinical stage IA-IIA melanoma within 3 months of inclusion
- Advanced melanoma, clinical stages IIB, IIC, III, or IV
- Patients with high risk of a new primary melanoma (dysplastic nevus syndrome, or family history of melanoma)
- History of melanoma skin cancer prior to the index diagnosis
- Previous cancer, excluding non-melanoma skin cancer
- Comorbidity that makes skin self-examination impossible (e.g. physical or mental disabilities, dementia or decreased cognitive function)
- non-detection of sentinel node in IB and IIA patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group The MelaCare intervention Patients in the intervention arm will receive follow-up conducted by melanoma nurses, where the patients will get tools to cope with the melanoma diagnosis and structured training in skin self-examination
- Primary Outcome Measures
Name Time Method Fear of cancer recurrence The primary outcome will be evaluated at approx. 24 months follow-up The primary outcome is the score of the validated 4-item Concerns About Recurrence Questionnaire (CARQ-4). A higher score indicates a higher level of FCR. A score of 12 or above is considered clinically relevant fear of cancer recurrence.
- Secondary Outcome Measures
Name Time Method Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7) Anxiety score will be evaluated at approx. 24 months follow-up The GAD-7 has a scale from 0-21, and a higher score is associated with increase in anxiety severity.
Evaluation of change from baseline in work ability by the validated work ability index Work ability will be evaluated at approx. 24 months follow-up The work ability index has a scale from 7-49, where higher scores indicates better work ability.
Evaluation of the number and characteristics of new primary melanomas and/or recurrences Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 60 months follow-up The investigators will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records.
Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L) Health status will be evaluated at approx. 24 months follow-up The EQ-5D-3L has a 3-level scale, and a higher level is associated with decrease in health status
Evaluation of the time and costs spend by the patients getting to and from the follow-up visits Time and costs spend will be evaluated at approx. 24 months follow-up The patients will fill in a study specific questionnaire informing time and money spent for transportation to and from the follow-up visits
Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9) Depression score will be evaluated at approx. 12 months follow-up The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity
Evaluation of change from in depression score by the validated Patient Health Questionnaire-9 (PhQ-9) Depression score will be evaluated at 24 months follow-up The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity
Evaluation of change from baseline in distress score by the validated distress thermometer Distress score will be evaluated at approx. 24 months follow-up The distress thermometer has a scale from 0-10, and a higher score is associated with increase in distress severity
Evaluation of health care costs of the new follow-up program compared to the current Health care costs evaluation will be evaluated at approx. 60 months follow-up We will evaluate the health care cost of new follow-up program compared to the current. Data will be collected using national registries.
Evaluation of change from baseline in activation score by the validated patient activation measure Activation measure will be evaluated at approx. 24 months follow-up The patient activation measure has a 100-point scale, and a higher score is associated with increase in activation level
Evaluation of time to diagnosis of a new primary melanoma and/or recurrence Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 60 months follow-up The investigators will evaluate time to diagnosis of a new melanomas using Breslows thickness as a proxy for time, and time to diagnosis recurrence measured by type of recurrence (local, regional or distant). The data will be collected using medical records.
Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic the number of extra clinical consultations with a doctor will be evaluated at approx. 60 months follow-up The investigators will evaluate number of extra clinical consultations with a doctor the patients will attend at the outpatient clinic. The data will be collected using electronic patient journal.
Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT) the number of extra scans will be evaluated at approx. 60 months follow-up The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal.
Trial Locations
- Locations (1)
Herlev and Gentofte Hospital
🇩🇰Copenhagen, Denmark