The MELAcare Study: A New Method for Surveillance of Melanoma Patients
ConditionCutaneous Melanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHerlev and Gentofte Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
The MelaCare intervention
Other interventionThe 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.
Treatment groups
378 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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. 6-8 months after randomization.2
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-up3
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-upSecondary outcomes
1
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.2
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-up3
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-up4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Herlev and Gentofte Hospital
Lead sponsor
Danish Cancer Society
Collaborator
Source ClinicalTrials.gov