Trial Outcomes & Findings for Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma. (NCT NCT03581188)

This pilot randomised clinical trial was conducted at 2 specialist-led clinics in metropolitan Sydney, Australia, and a primary care skin cancer clinic managed by general practitioners in metropolitan Newcastle, Australia between November 2018 and January 2020.

Of the 481 participants screened from November 1, 2018, to May 24, 2019, for eligibility, 125 were ineligible and 30 could not be contacted, leaving 326 participants who were eligible and contacted. Of them, 100 participants were randomized and enrolled in the trial.

Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.

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.

Adherence to the national guidelines recommendations on skin self-examination frequency was measured via a patient questionnaire asking participants how often they performed a complete self-examination of their skin over the previous 6 months.

To calculate this variable, the percentage of participants who examined the whole body skin surface during skin self-examination was calculated. Participants were asked if they performed a complete examination of their skin including hard to see areas such as neck/scalp, bottom and feet.

The number of times images were successfully submitted for teledermatologist review over the six-month intervention period by intervention group participants (count and percentage presented).

Total number of clinic visits attended (both scheduled and unscheduled)

This outcome has been assessed by conducting a review of medical records such as histopathology reports and doctor's letters. Descriptive statistics such as median with Interquartile Range of total number of skin lesions surgically excised during 12 months after randomisation were calculated.

This outcome was assessed by conducting a review of medical records at the clinic. Melanoma stage was classified according to the 8th American Joint Committee on Cancer. Stages range from 0 where the melanoma is confined to the epidermis (melanoma in situ) through to stage IV where the melanoma has spread to distant organs or lymph nodes.

New melanoma diagnoses prompted by visit type such as unscheduled visits and scheduled visits were calculated.

This outcome has been measured using the short version of the Depression Anxiety and Stress Scales (DASS-21). The DASS-21 is a set of three 7-item self-report scales designed to measure the emotional states of depression, anxiety and stress. The depression scale measures dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale measures autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale assesses difficulty relaxing, nervous arousal, and feeling irritable and impatient. Each scale ranges from "Did not apply to me" (0) to "Applied to me very much or most of the time" (3). A higher value is considered a worse outcome.