Clinical trial NCT03581188: Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
Official title: A Randomised Controlled Pilot Trial of Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma (Skin)
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: Melanoma and Skin Cancer Trials Limited
First posted: 2018-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to evaluate digitally supported skin self-examination compared to usual care in people treated for localised melanoma.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial
timeFrame: Baseline
Secondary outcomes:
measure: Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations.
timeFrame: Baseline, at 6 months
measure: Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination
timeFrame: Baseline, 6 months
measure: Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only)
timeFrame: At 6 months
measure: Number of Skin Clinic Visits Attended (Scheduled and Unscheduled)
timeFrame: During the 12 months after randomisation
measure: Number of Skin Lesions Surgically Excised
timeFrame: During the 12 months after randomisation
measure: New Subsequent Primary or Recurrent Melanoma Diagnoses
timeFrame: 12 months
measure: New Melanoma Diagnoses Prompted by Visit Type
timeFrame: During 12 months after randomisation
measure: General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Newcastle Skin Check
state: New South Wales
city: North Sydney
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Katy Bell, A/Prof
role: PRINCIPAL_INVESTIGATOR
References: