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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12616001716459 | Registry Identifier | ANZCTR |
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| Name | Class |
|---|---|
| Melanoma and Skin Cancer Trials Limited | OTHER |
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The purpose of this pilot study is to evaluate digitally supported skin self-examination compared to usual care in people treated for localised melanoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-led surveillance | Experimental | Participants receive a mobile dermatoscope that attaches to their smartphone to take photos of skin lesions for teledermatology, instructions on skin self-examination from the ASICA skin checker App, text and email reminders to perform self-examination every 2 months, an educational booklet 'Your guide to early melanoma', and scheduled visits to their clinician as required. |
|
| Clinician-led surveillance | Active Comparator | Participants receive an educational booklet 'Your guide to early melanoma' and scheduled visits to their clinician as required. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-led surveillance | Device | Usual care plus reminders, ASICA instructional videos, a mobile dermatoscope, an app that facilitates store-and-forward teledermatology, and fast-tracked unscheduled clinic visits. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katy Bell, A/Prof | University of Sydney | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newcastle Skin Check | Newcastle | New South Wales | 2290 | Australia | ||
| Melanoma Institute Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37632976 | Derived | Drabarek D, Ackermann D, Medcalf E, Bell KJL. Acceptability of a Hypothetical Reduction in Routinely Scheduled Clinic Visits Among Patients With History of a Localized Melanoma (MEL-SELF): Pilot Randomized Clinical Trial. JMIR Dermatol. 2023 Jun 26;6:e45865. doi: 10.2196/45865. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control: Clinician-led Surveillance | Participants received an educational booklet 'Your guide to early melanoma'and scheduled visits to their clinician as required. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Baseline |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-examination of the Skin | Participants will perform self-surveillance of the skin using a dermatoscope device. They will receive guidance from the ASICA skin checker and receive reminders every 2 months to perform self-examination. They will receive an educational booklet 'Your guide to early melanoma' and scheduled visits to their clinician as required. Self-examination of the skin: Participants will use a dermatoscope device to conduct self-examination of the skin. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety and confusion arising due to technical difficulties | Psychiatric disorders | Systematic Assessment | One person in the intervention group withdrew due to anxiety and confusion arising due to technical difficulties |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor Katy Bell | The University of Sydney, Australia | +61 415 764 321 | katy.bell@sydney.edu.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2020 | Feb 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Clinician-led surveillance | Behavioral | Usual care (scheduled clinician visits) |
|
| 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. | Baseline, 6 months |
| 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). | At 6 months |
| Number of Skin Clinic Visits Attended (Scheduled and Unscheduled) | Total number of clinic visits attended (both scheduled and unscheduled) | During the 12 months after randomisation |
| 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. | During the 12 months after randomisation |
| 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. | 12 months |
| New Melanoma Diagnoses Prompted by Visit Type | New melanoma diagnoses prompted by visit type such as unscheduled visits and scheduled visits were calculated. | During 12 months after randomisation |
| 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. | Baseline, 6 months |
| North Sydney |
| New South Wales |
| 2060 |
| Australia |
| Royal Prince Alfred Hospital | Sydney | New South Wales | 2050 | Australia |
| Discontinued intervention |
|
| BG001 | Control: Clinician-led Surveillance | Participants received an educational booklet 'Your guide to early melanoma'and scheduled visits to their clinician as required. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| No. of melanomas | Count of Participants | Participants |
|
| Melanoma substage (highest substage if multiple primary melanomas) | 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. | Count of Participants | Participants |
|
| Median time elapsed since diagnosis (IQR) | Median | Inter-Quartile Range | years |
|
| Site | Count of Participants | Participants |
|
| Main language spoken at home | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Level of education | Count of Participants | Participants |
|
| Remoteness (based on postal code) | Count of Participants | 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. | 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. | Posted | Count of Participants | Participants | Baseline, at 6 months |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline, 6 months |
|
|
|
|
| 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). | Posted | Count of Participants | Participants | At 6 months |
|
|
|
| Secondary | Number of Skin Clinic Visits Attended (Scheduled and Unscheduled) | Total number of clinic visits attended (both scheduled and unscheduled) | Posted | Median | Inter-Quartile Range | Clinic visits | During the 12 months after randomisation |
|
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | Skin lesions surgically excised | During the 12 months after randomisation |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | New Melanoma Diagnoses Prompted by Visit Type | New melanoma diagnoses prompted by visit type such as unscheduled visits and scheduled visits were calculated. | 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. | Posted | Count of Participants | Participants | During 12 months after randomisation |
|
|
|
|
| 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. | There was missing data | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months |
|
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 1 |
| 49 |
| EG001 | Control | Participants will receive an educational booklet 'Your guide to early melanoma'and scheduled visits to their clinician as required. | 0 | 51 | 0 | 51 | 0 | 51 |
|
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| ≥2 skin self examinations |
|
| Follow-up |
|
|
| Yes |
|
| Follow-up |
|
|
| 3 |
|
| IB |
|
| IIA |
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| IIB |
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| IIC |
|
| Total |
|
| Risk Ratio (RR) |
| 0 |
| 2-Sided |
| 95 |
| -9 |
| 10 |
| Superiority |
| Follow-up |
|
|