Melanoma (Skin)
Conditions
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.
Interventions
DEVICEPatient-led surveillance
Usual care plus reminders, ASICA instructional videos, a mobile dermatoscope, an app that facilitates store-and-forward teledermatology, and fast-tracked unscheduled clinic visits.
BEHAVIORALClinician-led surveillance
Usual care (scheduled clinician visits)
Sponsors
Melanoma and Skin Cancer Trials Limited
University of Sydney
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination | Baseline, 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. |
| Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only) | At 6 months | 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). |
| Number of Skin Clinic Visits Attended (Scheduled and Unscheduled) | During the 12 months after randomisation | Total number of clinic visits attended (both scheduled and unscheduled) |
| Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations. | Baseline, at 6 months | 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. |
| New Subsequent Primary or Recurrent Melanoma Diagnoses | 12 months | 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 | During 12 months after randomisation | New melanoma diagnoses prompted by visit type such as unscheduled visits and scheduled visits were calculated. |
| General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21 | Baseline, 6 months | 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. |
| Number of Skin Lesions Surgically Excised | During the 12 months after randomisation | 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. |
Countries
Australia
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention: Patient-led Surveillance Patient-led surveillance comprised instructional videos on how to perform SSE, reminders to undertake SSE, a mobile dermatoscope that attached to their smartphone, an app that facilitated store-and-forward teledermatology, and fast-tracked unscheduled clinic visits. They received an educational booklet 'Your guide to early melanoma' and scheduled visits to their clinician as required. | 49 |
| Control: Clinician-led Surveillance Participants received an educational booklet 'Your guide to early melanoma'and scheduled visits to their clinician as required. | 51 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued intervention | 11 | 8 |
| Overall Study | Inclusion criteria not met | 3 | 2 |
| Overall Study | Lost to Follow-up | 5 | 5 |
Baseline characteristics
| Characteristic | Total | Control: Clinician-led Surveillance | Intervention: Patient-led Surveillance |
|---|---|---|---|
| Age, Continuous | 58.7 Years STANDARD_DEVIATION 12 | 59.7 Years STANDARD_DEVIATION 11.6 | 57.5 Years STANDARD_DEVIATION 12.3 |
| Level of education Bachelor's degree | 27 Participants | 16 Participants | 11 Participants |
| Level of education High school diploma/certificate | 20 Participants | 9 Participants | 11 Participants |
| Level of education No formal | 0 Participants | 0 Participants | 0 Participants |
| Level of education Postgraduate degree or higher | 23 Participants | 11 Participants | 12 Participants |
| Level of education Primary school | 1 Participants | 1 Participants | 0 Participants |
| Level of education Unknown | 13 Participants | 7 Participants | 6 Participants |
| Level of education Vocational diploma/certificate | 16 Participants | 7 Participants | 9 Participants |
| Main language spoken at home English | 87 Participants | 44 Participants | 43 Participants |
| Main language spoken at home Other | 13 Participants | 7 Participants | 6 Participants |
| Marital status De facto/committed relationship | 8 Participants | 5 Participants | 3 Participants |
| Marital status Married | 71 Participants | 33 Participants | 38 Participants |
| Marital status Separated/divorced | 1 Participants | 1 Participants | 0 Participants |
| Marital status Single, never married | 4 Participants | 2 Participants | 2 Participants |
| Marital status Unknown | 13 Participants | 7 Participants | 6 Participants |
| Marital status Widowed | 3 Participants | 3 Participants | 0 Participants |
| Median time elapsed since diagnosis (IQR) First melanoma diagnosis | 5.6 years | 5.9 years | 5.5 years |
| Median time elapsed since diagnosis (IQR) Most recent melanoma diagnosis | 4.7 years | 5.6 years | 4.3 years |
| Melanoma substage (highest substage if multiple primary melanomas) 0 | 36 Participants | 18 Participants | 18 Participants |
| Melanoma substage (highest substage if multiple primary melanomas) IA | 49 Participants | 22 Participants | 27 Participants |
| Melanoma substage (highest substage if multiple primary melanomas) IB | 9 Participants | 6 Participants | 3 Participants |
| Melanoma substage (highest substage if multiple primary melanomas) IIA | 1 Participants | 1 Participants | 0 Participants |
| Melanoma substage (highest substage if multiple primary melanomas) IIB | 2 Participants | 2 Participants | 0 Participants |
| Melanoma substage (highest substage if multiple primary melanomas) III/IV | 2 Participants | 2 Participants | 0 Participants |
| Melanoma substage (highest substage if multiple primary melanomas) Unknown | 1 Participants | 0 Participants | 1 Participants |
| No. of melanomas 1 | 76 Participants | 43 Participants | 33 Participants |
| No. of melanomas 2 | 13 Participants | 5 Participants | 8 Participants |
| No. of melanomas 3 or more | 11 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Indigenous status Neither Aboriginal nor Torres Strait Islander | 74 Participants | 33 Participants | 41 Participants |
| Race/Ethnicity, Customized Indigenous status Unknown | 26 Participants | 18 Participants | 8 Participants |
| Remoteness (based on postal code) Inner regional/rural area | 7 Participants | 2 Participants | 5 Participants |
| Remoteness (based on postal code) Metropolitan area/city | 80 Participants | 42 Participants | 38 Participants |
| Remoteness (based on postal code) Unknown | 13 Participants | 7 Participants | 6 Participants |
| Sex: Female, Male Female | 46 Participants | 24 Participants | 22 Participants |
| Sex: Female, Male Male | 54 Participants | 27 Participants | 27 Participants |
| Site Newcastle | 45 Participants | 23 Participants | 22 Participants |
| Site Sydney | 55 Participants | 28 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 51 |
| other Total, other adverse events | 1 / 49 | 0 / 51 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 |
Outcome results
Primary
The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial
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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Who Were Eligible and Contacted | The Percentage of Eligible and Contacted Patients Who Were Randomised Into the Trial | 100 Participants |
Secondary
Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations.
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.
Time frame: Baseline, at 6 months
Population: There were missing data at baseline for 7 (14%) participants in the control group and 6 (12%) in intervention group; and at follow-up for 15 (29%) in the control group and 19 (39%) in intervention group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patients Who Were Eligible and Contacted | Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations. | Baseline | <2 skin self examinations | 13 Participants |
| Patients Who Were Eligible and Contacted | Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations. | Baseline | ≥2 skin self examinations | 30 Participants |
| Patients Who Were Eligible and Contacted | Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations. | Follow-up | <2 skin self examinations | 3 Participants |
| Patients Who Were Eligible and Contacted | Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations. | Follow-up | ≥2 skin self examinations | 27 Participants |
| Control: Clinician-led Surveillance | Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations. | Follow-up | ≥2 skin self examinations | 26 Participants |
| Control: Clinician-led Surveillance | Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations. | Baseline | <2 skin self examinations | 16 Participants |
| Control: Clinician-led Surveillance | Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations. | Follow-up | <2 skin self examinations | 10 Participants |
| Control: Clinician-led Surveillance | Adherence to Recommended Total Body Skin Self Examinations Practice: Frequency of Skin Self-examinations. | Baseline | ≥2 skin self examinations | 28 Participants |
Comparison: Odds ratios report differences between groups at follow-up.95% CI: [0.9, 14]
Secondary
Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination
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.
Time frame: Baseline, 6 months
Population: There were missing data at baseline for 6 (12%) participants in the control group and 5 (10%) in intervention group; and at follow-up for 15 (29%) in the control and 18 (37%) in the intervention group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patients Who Were Eligible and Contacted | Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination | Baseline | No | 36 Participants |
| Patients Who Were Eligible and Contacted | Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination | Baseline | Yes | 8 Participants |
| Patients Who Were Eligible and Contacted | Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination | Follow-up | No | 14 Participants |
| Patients Who Were Eligible and Contacted | Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination | Follow-up | Yes | 17 Participants |
| Control: Clinician-led Surveillance | Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination | Follow-up | Yes | 13 Participants |
| Control: Clinician-led Surveillance | Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination | Baseline | No | 38 Participants |
| Control: Clinician-led Surveillance | Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination | Follow-up | No | 23 Participants |
| Control: Clinician-led Surveillance | Adherence to Recommended Total Body Skin Self Examinations Practice: Thoroughness of Skin Self-examination | Baseline | Yes | 7 Participants |
95% CI: [0.8, 5.7]
Secondary
General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21
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.
Time frame: Baseline, 6 months
Population: There was missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Who Were Eligible and Contacted | General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21 | Baseline | 9.4 score on a scale | Standard Deviation 11.2 |
| Patients Who Were Eligible and Contacted | General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21 | Follow-up | 6.5 score on a scale | Standard Deviation 7.1 |
| Control: Clinician-led Surveillance | General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21 | Baseline | 14 score on a scale | Standard Deviation 15.3 |
| Control: Clinician-led Surveillance | General Anxiety, Stress, and Depression Measured Using the Depression Anxiety Stress Scales-21 | Follow-up | 9.9 score on a scale | Standard Deviation 14.5 |
95% CI: [-5.8, 3]
Secondary
New Melanoma Diagnoses Prompted by Visit Type
New melanoma diagnoses prompted by visit type such as unscheduled visits and scheduled visits were calculated.
Time frame: During 12 months after randomisation
Population: During the trial, 11 participants were diagnosed with a subsequent new primary melanoma or recurrence, including 8 in the intervention group and 3 in the control group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Who Were Eligible and Contacted | New Melanoma Diagnoses Prompted by Visit Type | New melanoma diagnoses at an unscheduled visit | 5 Participants |
| Patients Who Were Eligible and Contacted | New Melanoma Diagnoses Prompted by Visit Type | New melanoma diagnoses at a scheduled visit | 3 Participants |
| Control: Clinician-led Surveillance | New Melanoma Diagnoses Prompted by Visit Type | New melanoma diagnoses at an unscheduled visit | 0 Participants |
| Control: Clinician-led Surveillance | New Melanoma Diagnoses Prompted by Visit Type | New melanoma diagnoses at a scheduled visit | 3 Participants |
Comparison: New melanoma diagnoses prompted at unscheduled visit95% CI: [2, 19]
Comparison: New melanoma diagnoses prompted at scheduled visit95% CI: [-9, 10]
Secondary
New Subsequent Primary or Recurrent Melanoma Diagnoses
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.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Who Were Eligible and Contacted | New Subsequent Primary or Recurrent Melanoma Diagnoses | IB | 0 Participants |
| Patients Who Were Eligible and Contacted | New Subsequent Primary or Recurrent Melanoma Diagnoses | IIB | 0 Participants |
| Patients Who Were Eligible and Contacted | New Subsequent Primary or Recurrent Melanoma Diagnoses | IA | 2 Participants |
| Patients Who Were Eligible and Contacted | New Subsequent Primary or Recurrent Melanoma Diagnoses | IIC | 0 Participants |
| Patients Who Were Eligible and Contacted | New Subsequent Primary or Recurrent Melanoma Diagnoses | IIA | 0 Participants |
| Patients Who Were Eligible and Contacted | New Subsequent Primary or Recurrent Melanoma Diagnoses | Total | 8 Participants |
| Patients Who Were Eligible and Contacted | New Subsequent Primary or Recurrent Melanoma Diagnoses | 0 | 6 Participants |
| Control: Clinician-led Surveillance | New Subsequent Primary or Recurrent Melanoma Diagnoses | Total | 3 Participants |
| Control: Clinician-led Surveillance | New Subsequent Primary or Recurrent Melanoma Diagnoses | 0 | 1 Participants |
| Control: Clinician-led Surveillance | New Subsequent Primary or Recurrent Melanoma Diagnoses | IA | 1 Participants |
| Control: Clinician-led Surveillance | New Subsequent Primary or Recurrent Melanoma Diagnoses | IB | 0 Participants |
| Control: Clinician-led Surveillance | New Subsequent Primary or Recurrent Melanoma Diagnoses | IIA | 0 Participants |
| Control: Clinician-led Surveillance | New Subsequent Primary or Recurrent Melanoma Diagnoses | IIB | 0 Participants |
| Control: Clinician-led Surveillance | New Subsequent Primary or Recurrent Melanoma Diagnoses | IIC | 1 Participants |
Comparison: For new melanoma diagnoses, we calculated the difference in proportions and confidence intervals using the χ2 method without continuity correction. We included baseline measurement of the outcome in the models as a covariate to estimate between group difference in change from baseline.95% CI: [-2, 23]
Secondary
Number of Skin Clinic Visits Attended (Scheduled and Unscheduled)
Total number of clinic visits attended (both scheduled and unscheduled)
Time frame: During the 12 months after randomisation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Who Were Eligible and Contacted | Number of Skin Clinic Visits Attended (Scheduled and Unscheduled) | 2 Clinic visits |
| Control: Clinician-led Surveillance | Number of Skin Clinic Visits Attended (Scheduled and Unscheduled) | 1 Clinic visits |
95% CI: [1.1, 2.1]
Secondary
Number of Skin Lesions Surgically Excised
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.
Time frame: During the 12 months after randomisation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Who Were Eligible and Contacted | Number of Skin Lesions Surgically Excised | 1 Skin lesions surgically excised |
| Control: Clinician-led Surveillance | Number of Skin Lesions Surgically Excised | 0 Skin lesions surgically excised |
95% CI: [0.6, 2]
Secondary
Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only)
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).
Time frame: At 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Who Were Eligible and Contacted | Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only) | 0 | 23 Participants |
| Patients Who Were Eligible and Contacted | Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only) | 1 | 12 Participants |
| Patients Who Were Eligible and Contacted | Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only) | 2 | 12 Participants |
| Patients Who Were Eligible and Contacted | Successful Submission of Dermoscopic Images for Teledermatology (Intervention Group Only) | 3 | 2 Participants |