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| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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 |
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| Control group | No Intervention | Patients in the control arm will receive clinical follow-up according to the current standard of care for their clinical stage. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The MelaCare intervention | Other | The primary principles applied will be:
The intervention will include 4 components:
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara M Hansen, MD | Contact | +4538681296 | sara.moelgaard.hansen@regionh.dk | |
| Lisbet R Hölmich, Professor | Contact | +4538681243 | lisbet.rosenkrantz.hoelmich@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lisbet R Hölmich, Professor | Herlev and Gentofte Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte Hospital | Recruiting | Copenhagen | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40504479 | Derived | Hansen SM, Johansen C, Kasparian NA, Grand MK, Bidstrup PE, Holmich LR. Employing skin self-examination and fear of cancer recurrence management in early-stage melanoma follow-up: evaluation of the MELACARE intervention in a randomised controlled trial. J Cancer Surviv. 2025 Jun 12. doi: 10.1007/s11764-025-01841-1. Online ahead of print. |
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There are no plan to share IPD with other researchers.
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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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 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |