Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000384358
Ethics application status
Approved
Date submitted
15/07/2008
Date registered
1/08/2008
Date last updated
23/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a video-delivered intervention compared to standard brochures only increase their skin-self examination behaviour for the early detection of melanoma in men 50 years or older?
Scientific title
Do men 50 years or older who receive a video-delivered intervention compared to standard brochures only increase their skin-self examination behaviour for the early detection of melanoma?
Secondary ID [1] 282566 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer 3401 0
Melanoma 3402 0
Condition category
Condition code
Cancer 3549 3549 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After informed consent is sought and the baseline interview completed, participants will be randomized by computer-generated random number list into the intervention or control groups stratified by area of residence (south east corner of QLD versus rest of QLD) aiming to achieve equal numbers in these groups.

Men assigned to the intervention group will receive one video, which runs for approximately 12 minutes, recommending that participants conduct a whole-body skin self-examination (SSE) at least once a month. Together with the video, participants will receive a body pictogram that they can use to mark lesions while they are conducting a SSE and to record the dates of their SSEs. Participants within both the intervention and control condition will receive standard written educational materials available to the public from the Cancer Council Queensland entitled “Take the time to spot the difference”. This brochure displays photographs of benign and malignant lesions on the front and explains the particulars of every lesion on the reverse side. It recommends sun protection and regular skin self-examination without giving details on how to do so.
Men are asked to watch the video as soon as possible after receiving it at their own leisure. Men in the intervention group will receive two post-card reminders, two and four weeks after receiving the intervention video. The first postcard will remind them to watch the DVD, the second will remind them to conduct a whole-body skin self-examination and present to a doctor for a whole-body clinical exam with any lesion of concern.
Intervention code [1] 3125 0
Early detection / Screening
Comparator / control treatment
Subjects assigned to the control group will also receive the standard written educational materials (“Take the time to spot the difference”) available to the public from the Queensland Cancer Fund at the same time as the video-based material is mailed to intervention group participants - about two weeks after baseline interviews are completed. No further contact will be made with the control group participants apart from the telephone interviews, at 7 and 13 months, to collect the outcomes to evaluate the effectiveness of the intervention. Control group participants can receive the video materials at the end of the study period if they wish.
Control group
Active

Outcomes
Primary outcome [1] 4449 0
Number of whole-body skin self-examinations (SSE). This will be assessed by independent telephone survey staff blind to the participants group assignment. The main questions of this telephone interview have been used within our previous research and have good reliability and validity. Participants will be asked whether they have checked their own skin over the past 6 months, if yes, how many times. To facilitate accurate assessment of the degree of SSE performed (none, checks of particular spots or moles only, part-body SSE, whole-body SSE), participants will be asked to nominate the body area(s) that they included in their last SSE. In addition, we will assess whether SSE was performed using a full-size mirror and hand-held mirror and/or if another person was available. Further questions will assess relevant medical details including restrictions in mobility or vision that could impede thorough SSE.
Timepoint [1] 4449 0
At baseline, and at 7 and 13 months after intervention commencement.
Secondary outcome [1] 7521 0
Part or whole-body clinical skin examinations by a doctor (CSE). This will be assessed via participant self-report during the telephone interview, using previously validated questions. Participants who report a clinical skin examination (CSE) will be asked where they received their last examination, if there was any delay in getting an appointment and reasons for delay, who initiated the CSE, what the reason for this examination was and what management was chosen by the doctor for any lesion detected during this examination (excision/biopsy, non-surgical treatment, monitoring, no treatment).

For the cost-effectiveness analysis, the project manager will collect all resources relating to the preparation and development of the intervention, participant recruitment, delivery or operational costs, data collection costs and any other expenses required. Costs of follow-up diagnostic and management resources used by GPs or histopathology specialists subsequent to any CSEs participants will also be estimated. The data on costs will be derived from doctors? reports to obtain type and quantity of health resources used and valued using the Medicare Benefits Schedule. Although these resources are not directly considered inputs of the intervention service, the rationale for their inclusion is to investigate the use of health care resources attributable to the intervention.
Timepoint [1] 7521 0
At 7 and 13 months.
Secondary outcome [2] 7522 0
Management by doctors of any suspicious skin lesions. This will be assessed by following all visits to a doctor for any skin lesions men found during their skin self-examinations. Doctors will be asked about their management of the lesions. For skin examinations resulting in a surgical intervention (punch or shave biopsy, excision or curettage), histopathological data will be requested including the site, morphology, laterality, presence or absence of pigmentation and histological diagnosis. Histopathology reports will the entered into a database using the ICD-O coding system by trained coders.
Timepoint [2] 7522 0
At 7 and 13 months.

Eligibility
Key inclusion criteria
Males, 50 years and above, live in Queensland Australia.
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Already had melanoma, no telephone number, cognitive or hearing impairment, non-English speaking, unable to give informed consent, too ill, deceased, no access to DVD/video player.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be selected at random from the Queensland electoral roll stratified by area of residence and will be invited to participate by mail. A study pack will be mailed to all potential participants, including an invitation letter, a study information sheet, consent form, and a reply-paid envelope. Consent forms will be designed for self-completion. Non-respondents will be followed-up after two weeks by repeat mailing and then by telephone. Persons not listed in the White Pages will be excluded. Those who give initial consent will be contacted by telephone to assess their eligibility. Random allocation to treatment will occur after baseline interview, by independent central computer generated random list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will then be randomized by computer-generated random number list into the intervention or control groups stratified by area of residence (south east corner of QLD versus rest of QLD).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2008
Actual
2/06/2008
Date of last participant enrolment
Anticipated
Actual
28/10/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3584 0
Government body
Name [1] 3584 0
National Health and Medical Research Council
Country [1] 3584 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Road
Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 3236 0
Government body
Name [1] 3236 0
Cancer Council Queensland
Address [1] 3236 0
Gregory Terrace
Spring Hill QLD 4004
Country [1] 3236 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5630 0
Queensland Human Research Ethics Committee
Ethics committee address [1] 5630 0
Ethics committee country [1] 5630 0
Australia
Date submitted for ethics approval [1] 5630 0
Approval date [1] 5630 0
09/10/2006
Ethics approval number [1] 5630 0
0600000645

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28743 0
A/Prof Monika Janda
Address 28743 0
Queensland University of Technology
School of Public Health Victoria Park Road Kelvin Grove, QLD 4059
Country 28743 0
Australia
Phone 28743 0
+61 7 3138 9674
Fax 28743 0
Email 28743 0
[email protected]
Contact person for public queries
Name 11900 0
Monika Janda
Address 11900 0
School of Public Health
Victoria Park Road
Kelvin Grove, QLD 4059
Country 11900 0
Australia
Phone 11900 0
+61 7 3138 9674
Fax 11900 0
+61 7 3138 3130
Email 11900 0
[email protected]
Contact person for scientific queries
Name 2828 0
Monika Janda
Address 2828 0
School of Public Health
Victoria Park Road
Kelvin Grove, QLD 4059
Country 2828 0
Australia
Phone 2828 0
+61 7 3138 9674
Fax 2828 0
+61 7 3138 3130
Email 2828 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of a skin self examination attitude scale using an item response theory model approach.2014https://dx.doi.org/10.1186/s12955-014-0189-x
Dimensions AIClinical Skin Examination Outcomes After a Video-Based Behavioral Intervention: Analysis From a Randomized Clinical Trial2014https://doi.org/10.1001/jamadermatol.2013.9313
N.B. These documents automatically identified may not have been verified by the study sponsor.