The MELAcare Study: A New Method for Surveillance of Melanoma Patients

Study Overview
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Brief Summary
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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.

Official Title
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The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients

Conditions
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Cutaneous Melanoma

Intervention / Treatment
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* Other: The MelaCare intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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 | Other: The MelaCare intervention<br>* The primary principles applied will be: Meta-cognitive strategies and normalization of emotions Self efficacy related to SSE and knowledge on when to seek a doctor for clinical examination The intervention will include 4 components: An educational booklet Doctor consultation to ensure correct SSE skills and compliance to the protocol 3-5 sessions with a experienced and specially trained melanoma nurse Use of patients' answers from the Patient Reported Outcome 'Functional Assessment of Cancer Treatment - Melanoma' (FACT-M) at the nurse sessions to address current emotional and/or physical sequelae.<br>|
| No Intervention: Control group<br>Patients in the control arm will receive clinical follow-up according to the current standard of care for their clinical stage. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of cancer recurrence | 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. | The primary outcome will be evaluated at approx. 6-8 months after randomization. | 
| Fear of cancer recurrence | 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. | The primary outcome will be evaluated at approx. 12 months follow-up | 
| Fear of cancer recurrence | 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. | The primary outcome will be evaluated at approx. 24 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9) | The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity | Depression score will be evaluated at approx. 6-8 months after randomization. | 
| Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9) | The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity | Depression score will be evaluated at approx. 12 months follow-up | 
| Evaluation of change from in depression score by the validated Patient Health Questionnaire-9 (PhQ-9) | The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity | Depression score will be evaluated at 24 months follow-up | 
| Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7) | The GAD-7 has a scale from 0-21, and a higher score is associated with increase in anxiety severity. | Anxiety score will be evaluated at approx. 6-8 months after randomization. | 
| Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7) | The GAD-7 has a scale from 0-21, and a higher score is associated with increase in anxiety severity. | Anxiety score will be evaluated at approx.12 months follow-up | 
| Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7) | The GAD-7 has a scale from 0-21, and a higher score is associated with increase in anxiety severity. | Anxiety score will be evaluated at approx. 24 months follow-up | 
| Evaluation of change from baseline in distress score by the validated distress thermometer | The distress thermometer has a scale from 0-10, and a higher score is associated with increase in distress severity | Distress score will be evaluated at approx. 6-8 months after randomization. | 
| Evaluation of change from baseline in distress score by the validated distress thermometer | The distress thermometer has a scale from 0-10, and a higher score is associated with increase in distress severity | Distress score will be evaluated at approx.12 months follow-up | 
| Evaluation of change from baseline in distress score by the validated distress thermometer | The distress thermometer has a scale from 0-10, and a higher score is associated with increase in distress severity | Distress score will be evaluated at approx. 24 months follow-up | 
| Evaluation of change from baseline in activation score by the validated patient activation measure | The patient activation measure has a 100-point scale, and a higher score is associated with increase in activation level | Activation measure will be evaluated at approx. 6-8 months after randomization. | 
| Evaluation of change from baseline in activation score by the validated patient activation measure | The patient activation measure has a 100-point scale, and a higher score is associated with increase in activation level | Activation measure will be evaluated at approx.12 months follow-up | 
| Evaluation of change from baseline in activation score by the validated patient activation measure | The patient activation measure has a 100-point scale, and a higher score is associated with increase in activation level | Activation measure will be evaluated at approx. 24 months follow-up | 
| Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L) | The EQ-5D-3L has a 3-level scale, and a higher level is associated with decrease in health status | Health status will be evaluated at approx. 6-8 months after randomization. | 
| Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L) | The EQ-5D-3L has a 3-level scale, and a higher level is associated with decrease in health status | Health status will be evaluated at approx.12 months follow-up | 
| Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L) | The EQ-5D-3L has a 3-level scale, and a higher level is associated with decrease in health status | Health status will be evaluated at approx. 24 months follow-up | 
| Evaluation of change from baseline in work ability by the validated work ability index | The work ability index has a scale from 7-49, where higher scores indicates better work ability. | Work ability will be evaluated at approx. 6-8 months after randomization. | 
| Evaluation of change from baseline in work ability by the validated work ability index | The work ability index has a scale from 7-49, where higher scores indicates better work ability. | Work ability will be evaluated at approx.12 months follow-up | 
| Evaluation of change from baseline in work ability by the validated work ability index | The work ability index has a scale from 7-49, where higher scores indicates better work ability. | Work ability will be evaluated at approx. 24 months follow-up | 
| Evaluation of the time and costs spend by the patients getting to and from the follow-up visits | The patients will fill in a study specific questionnaire informing time and money spent for transportation to and from the follow-up visits | Time and costs spend will be evaluated at approx. 6-8 months after randomization. | 
| Evaluation of the time and costs spend by the patients getting to and from the follow-up visits | The patients will fill in a study specific questionnaire informing time and money spent for transportation to and from the follow-up visits | Time and costs spend will be evaluated at approx.12 months follow-up | 
| Evaluation of the time and costs spend by the patients getting to and from the follow-up visits | The patients will fill in a study specific questionnaire informing time and money spent for transportation to and from the follow-up visits | Time and costs spend will be evaluated at approx. 24 months follow-up | 
| Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic | 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. | the number of extra clinical consultations with a doctor will be evaluated at approx. 6-8 months after randomization. | 
| Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic | 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. | the number of extra clinical consultations with a doctor will be evaluated at approx. 12 months follow-up | 
| Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic | 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. | the number of extra clinical consultations with a doctor will be evaluated at approx. 24 months follow-up | 
| Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic | 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. | the number of extra clinical consultations with a doctor will be evaluated at approx. 60 months follow-up | 
| Evaluation of the number and characteristics of new primary melanomas and/or recurrences | The investigator will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records. | Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 6-8 months after randomization. | 
| Evaluation of the number and characteristics of new primary melanomas and/or recurrences | The investigator will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records. | Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx.12 months follow-up | 
| Evaluation of the number and characteristics of new primary melanomas and/or recurrences | The investigators will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records. | Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 24 months follow-up | 
| Evaluation of the number and characteristics of new primary melanomas and/or recurrences | The investigators will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records. | Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 60 months follow-up | 
| Evaluation of time to diagnosis of a new primary melanoma and/or recurrence | 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. | Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 6-8 months after randomization. | 
| Evaluation of time to diagnosis of a new primary melanoma and/or recurrence | 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. | Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 12 months follow-up | 
| Evaluation of time to diagnosis of a new primary melanoma and/or recurrence | 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. | Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 24 months follow-up | 
| Evaluation of time to diagnosis of a new primary melanoma and/or recurrence | 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. | Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 60 months follow-up | 
| Evaluation of health care costs of the new follow-up program compared to the current | We will evaluate the health care cost of new follow-up program compared to the current. Data will be collected using national registries. | Health care costs evaluation will be evaluated at approx. 60 months follow-up | 
| Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT) | The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal. | the number of extra scans will be evaluated at approx. 6-8 months after randomization. | 
| Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT) | The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal. | the number of extra scans will be evaluated at approx. 12 months follow-up | 
| Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT) | The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal. | the number of extra scans will be evaluated at approx. 24 months follow-up | 
| Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT) | The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal. | the number of extra scans will be evaluated at approx. 60 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cutaneous melanoma, follow-up, nurse-led follow-up, skin self-examination, survivorship