NCT05253872招募中不适用
The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Fear of cancer recurrence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention group
Experimental
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
干预措施: The MelaCare intervention (Other)
Control group
No Intervention
Patients in the control arm will receive clinical follow-up according to the current standard of care for their clinical stage.
结局指标
主要结局
Fear of cancer recurrence
时间窗: 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.
Fear of cancer recurrence
时间窗: 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.
Fear of cancer recurrence
时间窗: 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.
次要结局
- 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. 24 months follow-up)
- Evaluation of change from baseline in work ability by the validated work ability index(Work ability will be evaluated at approx. 24 months follow-up)
- 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. 60 months follow-up)
- 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. 24 months follow-up)
- 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. 24 months follow-up)
- Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9)(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)(Depression score will be evaluated at 24 months follow-up)
- Evaluation of change from baseline in distress score by the validated distress thermometer(Distress score will be evaluated at approx. 24 months follow-up)
- 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)
- Evaluation of change from baseline in activation score by the validated patient activation measure(Activation measure will be evaluated at approx. 24 months follow-up)
- 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. 60 months follow-up)
- 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. 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 number of extra scans will be evaluated at approx. 60 months follow-up)
- 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.)
- 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.)
- 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.12 months follow-up)
- 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.)
- Evaluation of change from baseline in distress score by the validated distress thermometer(Distress score will be evaluated at approx.12 months follow-up)
- 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.)
- Evaluation of change from baseline in activation score by the validated patient activation measure(Activation measure 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)(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)(Health status will be evaluated at approx.12 months follow-up)
- 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.)
- Evaluation of change from baseline in work ability by the validated work ability index(Work ability 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(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(Time and costs spend 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 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 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 number of extra clinical consultations with a doctor will be evaluated at approx. 24 months follow-up)
- 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.)
- 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.12 months follow-up)
- 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. 24 months follow-up)
- 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.)
- 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. 12 months follow-up)
- 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. 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 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 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 number of extra scans will be evaluated at approx. 24 months follow-up)
研究者
Sara Molgaard Hansen
Principal investigator
Herlev and Gentofte Hospital
研究点 (1)
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