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NCT Number: NCT05253872

The MELAcare Study: 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.

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Key information

Conditions

Cutaneous Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The MelaCare intervention

Other

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 outcomes

  1. Fear of cancer recurrence

    Time frame: The primary outcome will be evaluated at approx. 6-8 months after randomization.

    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.

  2. Fear of cancer recurrence

    Time frame: The primary outcome will be evaluated at approx. 12 months follow-up

    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.

  3. Fear of cancer recurrence

    Time frame: The primary outcome will be evaluated at approx. 24 months follow-up

    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 outcomes

  1. Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9)

    Time frame: Depression score will be evaluated at approx. 6-8 months after randomization.

    The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity

  2. Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9)

    Time frame: Depression score will be evaluated at approx. 12 months follow-up

    The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity

  3. Evaluation of change from in depression score by the validated Patient Health Questionnaire-9 (PhQ-9)

    Time frame: Depression score will be evaluated at 24 months follow-up

    The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity

  4. Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7)

    Time frame: Anxiety score will be evaluated at approx. 6-8 months after randomization.

    The GAD-7 has a scale from 0-21, and a higher score is associated with increase in anxiety severity.

  5. Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7)

    Time frame: Anxiety score will be evaluated at approx.12 months follow-up

    The GAD-7 has a scale from 0-21, and a higher score is associated with increase in anxiety severity.

  6. Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7)

    Time frame: Anxiety score will be evaluated at approx. 24 months follow-up

    The GAD-7 has a scale from 0-21, and a higher score is associated with increase in anxiety severity.

  7. Evaluation of change from baseline in distress score by the validated distress thermometer

    Time frame: Distress score will be evaluated at approx. 6-8 months after randomization.

    The distress thermometer has a scale from 0-10, and a higher score is associated with increase in distress severity

  8. Evaluation of change from baseline in distress score by the validated distress thermometer

    Time frame: Distress score will be evaluated at approx.12 months follow-up

    The distress thermometer has a scale from 0-10, and a higher score is associated with increase in distress severity

  9. Evaluation of change from baseline in distress score by the validated distress thermometer

    Time frame: Distress score will be evaluated at approx. 24 months follow-up

    The distress thermometer has a scale from 0-10, and a higher score is associated with increase in distress severity

  10. Evaluation of change from baseline in activation score by the validated patient activation measure

    Time frame: Activation measure will be evaluated at approx. 6-8 months after randomization.

    The patient activation measure has a 100-point scale, and a higher score is associated with increase in activation level

  11. Evaluation of change from baseline in activation score by the validated patient activation measure

    Time frame: Activation measure will be evaluated at approx.12 months follow-up

    The patient activation measure has a 100-point scale, and a higher score is associated with increase in activation level

  12. Evaluation of change from baseline in activation score by the validated patient activation measure

    Time frame: Activation measure will be evaluated at approx. 24 months follow-up

    The patient activation measure has a 100-point scale, and a higher score is associated with increase in activation level

  13. Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)

    Time frame: Health status will be evaluated at approx. 6-8 months after randomization.

    The EQ-5D-3L has a 3-level scale, and a higher level is associated with decrease in health status

  14. Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)

    Time frame: Health status will be evaluated at approx.12 months follow-up

    The EQ-5D-3L has a 3-level scale, and a higher level is associated with decrease in health status

  15. Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)

    Time frame: Health status will be evaluated at approx. 24 months follow-up

    The EQ-5D-3L has a 3-level scale, and a higher level is associated with decrease in health status

  16. Evaluation of change from baseline in work ability by the validated work ability index

    Time frame: Work ability will be evaluated at approx. 6-8 months after randomization.

    The work ability index has a scale from 7-49, where higher scores indicates better work ability.

  17. Evaluation of change from baseline in work ability by the validated work ability index

    Time frame: Work ability will be evaluated at approx.12 months follow-up

    The work ability index has a scale from 7-49, where higher scores indicates better work ability.

  18. Evaluation of change from baseline in work ability by the validated work ability index

    Time frame: Work ability will be evaluated at approx. 24 months follow-up

    The work ability index has a scale from 7-49, where higher scores indicates better work ability.

  19. Evaluation of the time and costs spend by the patients getting to and from the follow-up visits

    Time frame: Time and costs spend will be evaluated at approx. 6-8 months after randomization.

    The patients will fill in a study specific questionnaire informing time and money spent for transportation to and from the follow-up visits

  20. Evaluation of the time and costs spend by the patients getting to and from the follow-up visits

    Time frame: Time and costs spend will be evaluated at approx.12 months follow-up

    The patients will fill in a study specific questionnaire informing time and money spent for transportation to and from the follow-up visits

  21. Evaluation of the time and costs spend by the patients getting to and from the follow-up visits

    Time frame: Time and costs spend will be evaluated at approx. 24 months follow-up

    The patients will fill in a study specific questionnaire informing time and money spent for transportation to and from the follow-up visits

  22. Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic

    Time frame: the number of extra clinical consultations with a doctor will be evaluated at approx. 6-8 months after randomization.

    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.

  23. Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic

    Time frame: the number of extra clinical consultations with a doctor will be evaluated at approx. 12 months follow-up

    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.

  24. Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic

    Time frame: the number of extra clinical consultations with a doctor will be evaluated at approx. 24 months follow-up

    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.

  25. Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic

    Time frame: the number of extra clinical consultations with a doctor will be evaluated at approx. 60 months follow-up

    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.

  26. Evaluation of the number and characteristics of new primary melanomas and/or recurrences

    Time frame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 6-8 months after randomization.

    The investigator will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records.

  27. Evaluation of the number and characteristics of new primary melanomas and/or recurrences

    Time frame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx.12 months follow-up

    The investigator will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records.

  28. Evaluation of the number and characteristics of new primary melanomas and/or recurrences

    Time frame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 24 months follow-up

    The investigators will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records.

  29. Evaluation of the number and characteristics of new primary melanomas and/or recurrences

    Time frame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 60 months follow-up

    The investigators will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records.

  30. Evaluation of time to diagnosis of a new primary melanoma and/or recurrence

    Time frame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 6-8 months after randomization.

    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.

  31. Evaluation of time to diagnosis of a new primary melanoma and/or recurrence

    Time frame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 12 months follow-up

    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.

  32. Evaluation of time to diagnosis of a new primary melanoma and/or recurrence

    Time frame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 24 months follow-up

    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.

  33. Evaluation of time to diagnosis of a new primary melanoma and/or recurrence

    Time frame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 60 months follow-up

    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.

  34. Evaluation of health care costs of the new follow-up program compared to the current

    Time frame: Health care costs evaluation will be evaluated at approx. 60 months follow-up

    We will evaluate the health care cost of new follow-up program compared to the current. Data will be collected using national registries.

  35. Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)

    Time frame: the number of extra scans will be evaluated at approx. 6-8 months after randomization.

    The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal.

  36. Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)

    Time frame: the number of extra scans will be evaluated at approx. 12 months follow-up

    The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal.

  37. Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)

    Time frame: the number of extra scans will be evaluated at approx. 24 months follow-up

    The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal.

  38. Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)

    Time frame: the number of extra scans will be evaluated at approx. 60 months follow-up

    The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisbet R Hölmich, Professor

CONTACT

[email protected]

+4538681243

Sara M Hansen, MD

CONTACT

[email protected]

+4538681296

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2028
First posted
Feb 24, 2022
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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