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

Cutaneous Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05253872
• Other study ID #: Melacare v1.0
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: March 2028

Study information

• Verified date: June 2023
• Source: Herlev and Gentofte Hospital
• Contact: Sara M Hansen, MD
• Phone: +4538681296
• Email: sara.moelgaard.hansen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 378
• Est. completion date: March 2028
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Melanoma
• Melanoma

Intervention

Other:
• The MelaCare intervention
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.

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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