Cutaneous Melanoma
Conditions
Keywords
cutaneous melanoma, follow-up, nurse-led follow-up, skin self-examination, survivorship
Brief 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.
Interventions
OTHERThe 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.
Sponsors
Danish Cancer Society
Herlev and Gentofte Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fear of cancer recurrence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9) | 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 |
| Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7) | 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. |
| Evaluation of change from baseline in distress score by the validated distress thermometer | 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 |
| Evaluation of change from baseline in activation score by the validated patient activation measure | 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 |
| Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L) | 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 |
| Evaluation of change from baseline in work ability by the validated work ability index | 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. |
| Evaluation of change from in depression score by the validated Patient Health Questionnaire-9 (PhQ-9) | 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 |
| Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic | 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. |
| Evaluation of the number and characteristics of new primary melanomas and/or recurrences | 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. |
| Evaluation of time to diagnosis of a new primary melanoma and/or recurrence | 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. |
| Evaluation of health care costs of the new follow-up program compared to the current | 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. |
| Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT) | 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. |
| Evaluation of the time and costs spend by the patients getting to and from the follow-up visits | 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 |
Countries
Denmark
Contacts
Primary ContactSara M Hansen, MD
Backup ContactLisbet R Hölmich, Professor
Outcome results
None listed