N/A
N=100
Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
Melanoma (Skin)
Bottom Line
View on ClinicalTrials.gov: NCT03581188 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial — 100 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient-led surveillance (Device); Clinician-led surveillance (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Sydney
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial |
100 | — |
| SECONDARY Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations. |
13; 16; 30; 28; 3; 10 | — |
| SECONDARY Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination |
36; 38; 8; 7; 14; 23 | — |
| SECONDARY Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only) |
23; 12; 12; 2 | — |
| SECONDARY Number of Skin Clinic Visits Attended (Scheduled and Unscheduled) |
2; 1 | — |
| SECONDARY Number of Skin Lesions Surgically Excised |
1; 0 | — |
| SECONDARY New Subsequent Primary or Recurrent Melanoma Diagnoses |
6; 1; 2; 1; 0; 0 | — |
| SECONDARY New Melanoma Diagnoses Prompted by Visit Type |
5; 0; 3; 3 | — |
| SECONDARY General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21 |
9.4; 14; 6.5; 9.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03581188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.