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

Primary Purpose

Cutaneous Melanoma

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
The MelaCare intervention
Sponsored by
Herlev and Gentofte Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cutaneous Melanoma focused on measuring cutaneous melanoma, follow-up, nurse-led follow-up, skin self-examination, survivorship

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herlev and Gentofte HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

Patients in the control arm will receive clinical follow-up according to the current standard of care for their clinical stage.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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
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
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
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.
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.
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.
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
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
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
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
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
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
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
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
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
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.
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.
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.
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 24, 2022
Last Updated
June 23, 2023
Sponsor
Herlev and Gentofte Hospital
Collaborators
Danish Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT05253872
Brief Title
The MELAcare Study: A New Method for Surveillance of Melanoma Patients
Official Title
The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital
Collaborators
Danish Cancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Melanoma
Keywords
cutaneous melanoma, follow-up, nurse-led follow-up, skin self-examination, survivorship

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
378 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara M Hansen, MD
Phone
+4538681296
Email
sara.moelgaard.hansen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lisbet R Hölmich, Professor
Phone
+4538681243
Email
lisbet.rosenkrantz.hoelmich@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisbet R Hölmich, Professor
Organizational Affiliation
Herlev and Gentofte Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Herlev and Gentofte Hospital
City
Copenhagen
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara M Hansen, MD
Phone
+4538681296
Email
sara.moelgaard.hansen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Lisbet R Hölmich, Professor
Phone
+4538681243
Email
lisbet.rosenkrantz.hoelmich@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plan to share IPD with other researchers.

Learn more about this trial

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

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