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A Research Study of Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma. (MEL-SELF)

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ClinicalTrials.gov Identifier: NCT03581188
Recruitment Status : Enrolling by invitation
First Posted : July 10, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Melanoma and Skin Cancer Trials Limited

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.

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 12 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.


Condition or disease Intervention/treatment Phase
Melanoma (Skin) Behavioral: Self-examination of the skin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Pilot Trial of Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma.
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Self-examination of the skin
Participants will use a dermatoscope device to conduct self-examination of the skin.

No Intervention: Control
Participants will receive an educational booklet 'Your guide to early melanoma'and scheduled visits to their clinician as required.



Primary Outcome Measures :
  1. Proportion of patients who are contacted and randomised into the trial (composite primary outcome) [ Time Frame: first 6 months of trial ]
    This will be assessed by using the trial management database to record those who were invited to participate and those who chose to participate.


Secondary Outcome Measures :
  1. Adherence with the national guidelines recommendations on Skin self examination practice (total body self-examination conducted two- monthly); [ Time Frame: Baseline, 6 months, 1 year ]
    This will be measured via a patient questionnaire asking participants how often they perform a complete self-examination.

  2. Level of fear of new or recurrent melanoma (FCR) severity. [ Time Frame: Baseline, 6 months, 1 year ]
    This outcome will be measured using the Fear of Cancer Recurrence Inventory (FCRI) severity subscale (9 items)

  3. General anxiety [ Time Frame: Baseline, 6 months, 1 year ]

    This outcome will be 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.


  4. Number of lesions surgically evaluated [ Time Frame: Baseline, 6 months, 1 year ]
    This outcome will be assessed by conducting a review of medical records at the clinic.

  5. Sensitivity of patient performed teledermoscopy for detecting skin lesions that warrant clinical review. [ Time Frame: 6 months, 1 year ]
    • Index test: teledermatology. A dermatologist who is blinded to clinical diagnosis + histopathology will review the patient performed teledermoscopy + text descriptions and assign skin lesions to the following clinical categories: clinical review warranted vs clinical review not warranted.
    • Reference test: Clinician opinion on whether review was warranted. An outcome assessor who is blinded to the teledermatology will review clinical notes +/- histopathology (where available) and assign skin lesions to the following clinical categories: clinical review warranted vs clinical review not warranted.

  6. Resource Use [ Time Frame: 6 months, 1 year ]
    This will be documented in a resource diary to measure health behaviours and service use, out-of-role, travel costs and carer costs.

  7. Stress, Depression [ Time Frame: Baseline, 6 months, 1 year ]

    This outcome will be 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.


  8. Knowledge of Skin self examination [ Time Frame: Baseline, 6 months, 1 year ]
    This will be measured using item developed by Janda et al. (not validated) and adapted for this study.

  9. Confidence in performing skin self examination [ Time Frame: Baseline, 6 months, 1 year ]
    This outcome will be measured using item developed by Janda et al. (not validated) and adapted for this study.

  10. Thoroughness of performing skin self examination [ Time Frame: Baseline, 6 months, 1 year ]
    This outcome will be measured using item developed by Janda et al. (not validated) and adapted for this study.

  11. Belief about performing skin self examination [ Time Frame: Baseline, 6 months, 1 year ]
    This outcome will be measured using item developed by Janda et al. (not validated) and adapted for this study.

  12. Attitude towards performing skin self examination [ Time Frame: Baseline, 6 months, 1 year ]
    This outcome will be measured using item developed by Janda et al. (not validated) and adapted for this study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581188


Locations
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Australia, New South Wales
Newcastle Skin Check
Newcastle, New South Wales, Australia, 2290
Melanoma Institute Australia
North Sydney, New South Wales, Australia, 2060
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Sponsors and Collaborators
Melanoma and Skin Cancer Trials Limited
University of Sydney
Investigators
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Principal Investigator: Katy Bell, Dr University of Sydney

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Responsible Party: Melanoma and Skin Cancer Trials Limited
ClinicalTrials.gov Identifier: NCT03581188     History of Changes
Other Study ID Numbers: ANZMTG 02.17
ACTRN12616001716459 ( Registry Identifier: ANZCTR )
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas