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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
378
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.
Herlev and Gentofte Hospital
Copenhagen, Denmark
RECRUITINGFear 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.
Time frame: 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.
Time frame: 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.
Time frame: The primary outcome will be evaluated at approx. 24 months follow-up
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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 frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: the number of extra scans will be evaluated at approx. 60 months follow-up
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