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

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

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 Overview

• Status: Recruiting
• Conditions: Cutaneous Melanoma
• Intervention / Treatment: Other: The MelaCare intervention

• Study Type: Interventional
• Enrollment (Estimated): 378
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara M Hansen, MD; Phone Number: +4538681296; Email: sara.moelgaard.hansen@regionh.dk
• Study Contact Backup: Name: Lisbet R Hölmich, Professor; Phone Number: +4538681243; Email: lisbet.rosenkrantz.hoelmich@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2730
    • Recruiting
    • Herlev and Gentofte Hospital
    • Contact: Sara M Hansen, MD; Phone Number: +4538681296; Email: sara.moelgaard.hansen@regionh.dk
    • Contact: Lisbet R Hölmich, Professor; Phone Number: +4538681243; Email: lisbet.rosenkrantz.hoelmich@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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.
No Intervention: Control group; 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?

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

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Collaborators: Danish Cancer Society
• Investigators: Study Chair: Lisbet R Hölmich, Professor, Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: follow-up; survivorship; cutaneous melanoma; skin self-examination; nurse-led follow-up
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: Melacare v1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No