A Randomised Controlled Pilot Trial of Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial
研究概览
简要总结
The purpose of this pilot study is to evaluate digitally supported skin self-examination compared to usual care in people treated for localised melanoma.
详细描述
Patients may be eligible to join this study if they are aged 18 years or above, have been treated for stage 0/I/II melanoma and are attending regular melanoma surveillance follow-ups at the Melanoma Institute Australia (MIA), Royal Prince Alfred Hospital (RPAH) or the Newcastle Skin Check Clinic.
People who are found to be eligible and who consent to participate will be randomised (allocated by chance) to the intervention or usual care in a 1:1 ratio. Usual care group will receive an educational booklet on early melanoma and the usual number of routine clinic visits. In addition to usual care, participants allocated to the intervention group will be required to download a skin checker App to their smartphone and will use a mobile dermatoscope to perform total body skin self-examinations every 2 months for 6 months in total. Email and SMS reminders will also be sent every two months to participants in the intervention group. Participants will be documented on how well they are able to perform a self skin examination, their levels of melanoma-related anxiety, the number of skin lesions biopsied or removed, and the costs of follow-up to the participant and to the healthcare system.
Frequent follow-up of localised melanoma is time and resource intensive, and has not shown improved outcomes. This pilot study will provide evidence on which model is best for follow-up care after treatment for localised melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients treated for stage 0/I/II melanoma and are attending regular melanoma follow-up as indicated by scheduled visit within next 12 months in clinic patient booking system and
- •Are able to self-examine;
- •Have a suitable study partner (spouse, partner, family member, friend);
- •Have a smart phone with access to Wifi / email / SMS text messaging;
- •Are able to give informed consent ;
- •Have sufficient English language skills to read the materials and complete the questionnaires;
排除标准
- •Unable to perform self-examination
- •No partner or friend to help with self-examination
- •Do not have access to a smart phone with Wifi/email/SMS text messaging
- •With a known past or current diagnosis of cognitive impairment
结局指标
主要结局
The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial
时间窗: Baseline
For the primary outcome (composite primary outcome), the percentage was estimated using the number of patients screened who were eligible and contacted as the denominator and the number of patients who were randomised as the numerator.
次要结局
- Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations.(Baseline, at 6 months)
- Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination(Baseline, 6 months)
- Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only)(At 6 months)
- New Melanoma Diagnoses Prompted by Visit Type(During 12 months after randomisation)
- General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21(Baseline, 6 months)
- New Subsequent Primary or Recurrent Melanoma Diagnoses(12 months)
- Number of Skin Clinic Visits Attended (Scheduled and Unscheduled)(During the 12 months after randomisation)
- Number of Skin Lesions Surgically Excised(During the 12 months after randomisation)