Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000577819
Ethics application status
Approved
Date submitted
24/05/2012
Date registered
29/05/2012
Date last updated
4/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
HealthY Texts: Improving health outcomes for generation Y: assessing the impact of personalised mobile telephone short messages on improving skin protection and early detection behaviours in young to mid-aged adults living in Queensaland, Australia
Scientific title
Improving health outcomes for generation Y: assessing the impact of personalised mobile telephone short messages on improving skin protection and early detection behaviours in young to mid-aged adults (18-42 years)
Secondary ID [1] 280569 0
nil
Universal Trial Number (UTN)
U1111-1131-1467
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer 286540 0
Sun safety 286541 0
Skin self examination 286542 0
Condition category
Condition code
Cancer 286809 286809 0 0
Malignant melanoma
Public Health 286848 286848 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive a total of 21 personalised text messages over a period of 12 months relating to either sun safety or skin self examination. The frequency of these text messages is as follows: One message per week for the first three months of the study, then one message per month for the remaining nine months. These messages contain tips on how to protect your skin from the sun, provide encouragement to do so, and act as reminders to do so. The sun safety text messages will be personalised by addressing the participant by name and will sometimes include a reference to an outdoor activity they have reported as doing outdoors on a regular basis. For example, one sun safety message is as follows: "Planning some outside activity this weekend (name)? Encourage your friends to be sun safe like you by wearing a hat & sunscreen. Have fun! Monika". The skin self examination messages will also be personalised by using the participant's name. These messages contain information about how to do a skin self examination, provide encouragement to do so, and act as reminders to do so. Participant gender will also determine what messages participants in this group receive. For example, female participants will receive this message: "Hey (Name), next time you’re doing your make-up take a closer look @ your face, neck & ears for skin spots or skin changes. Monika", whereas male participants will receive this message: "(name), next time you shave look in the mirror to check your scalp for any hidden skin spots. Part your hair using a comb to check each section. Monika". Telephone surveys, duration approximately 15-20 minutes, will take place at three different time points. The first survey will occur at baseline (before the first text message is sent), the second survey will take place three months into the study and the final survey will take place at 12 months, immediately post intervention. These surveys contain questions relating to demographics, lifestyle, behaviours and opinions and are designed to assess whether skin protection and skin self-examination intentions and behaviours change due to the intervention. The surveys will also assess the feasibility and acceptability of SMS as part of health behaviour interventions.
Intervention code [1] 284919 0
Behaviour
Intervention code [2] 284956 0
Lifestyle
Intervention code [3] 284957 0
Early detection / Screening
Comparator / control treatment
Participants in the control group will receive a total of 21 personalised text messages over a period of 12 months relating to physical activity. The frequency of these text messages is as follows: One message per week for the first three months of the study, then one message per month for the remaining nine months.

The physical activity messaged will be personalised by using the participant's first name to address them. These messages provide suggestions of ways to exercise, provide encouragement and act as reminders to exercise. An example of a physical activity message is as follows: (Name), remember for exercise to count it must be moderate intensity. You should be able to talk but not sing while you do it. Monika

Telephone surveys, duration approximately 15-20 minutes, will take place at three different time points. The first survey will occur at baseline (before the first text message is sent), the second survey will take place three months into the study and the final survey will take place at 12 months, immediately post intervention. These surveys are exactly the same as those completed by the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 287180 0
Skin protection behaviours. This will be assessed using questionnaires developed for this study by the researchers. These questionnaires will take place at baseline, three months into the intervention and at the end of the intervention (12 months after baseline). Each of these questionnaires is slightly different (baseline and 12 month are longer and similar in content, whereas the three month questionnaire is shorter). Each participant, irrespective of group allocation, will complete the same questionnaires.

These questionnaires contain questions specific to each outcome. In the case of skin protection, participants will be asked about sun protection methods and how often they are used (sun screen use, wearing a hat) etc.
Timepoint [1] 287180 0
Three months into the intervention and immediately post intervention (12 months). Responses will be compared to baseline
Primary outcome [2] 287182 0
Skin self examination. Skin protection behaviours. This will be assessed using questionnaires developed for this study by the researchers. These questionnaires will take place at baseline, three months into the intervention and at the end of the intervention (12 months after baseline). Each of these questionnaires is slightly different (baseline and 12 month are longer and similar in content, whereas the three month questionnaire is shorter). Each participant, irrespective of group allocation, will complete the same questionnaires.

Questions relating specifically to skin self examination will be asked in order to assess this outcome. These include questions about how often, in past 3 and 12 months participant has examined their own skin, whether they have found a spot or a mole of concern during a skin self examination etc.
Timepoint [2] 287182 0
Three months into the intervention and immediately post intervention (12 months). Responses will be compared to baseline
Secondary outcome [1] 297568 0
Feasibility and acceptability of SMS as a means of reaching young to mid-aged adults (18-42 years). This will be assessed during the 12 months questionnaire, which contains questions relating to satisfaction of the frequency of the text messages, satisfaction with the content of the text messages and whether they were ever referred back to (for example, to retrieve information about what to look out for when conducting a skin self examination). These questions, and the questionnaire in which they are contained, have been developed by the researchers for use in this study
Timepoint [1] 297568 0
Immediately post intervention (12 months)

Eligibility
Key inclusion criteria
Living in Queensland. Understand sufficient English; cognitive ability for consent; own a private mobile phone; no previous melanoma; Fitzpatrick skin types I-III (skin that always, usually or sometimes burns and never or sometimes tans); 18-42 years
Minimum age
18 Years
Maximum age
42 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under the age of 18 years and over the age of 42 years; does not understand sufficient English; does not have the ability to give informed consent; has previously been diagnosed with melanoma; has skin that does not burn; Has been advised not to exercise in 12 months prior to recruitment; does not own a private mobile phone

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)
Each eligible participant will be entered into a Microsoft Access database, along with their demographic information. Central randomization will then occur, with Microsoft Access randomly allocating each participant to one of the three groups: skin protection, skin self examination or physical activity. The researchers will be able to see which group each participant has been allocated to by accessing the participant information in Microsoft Access. However, those conducting the telephone questionnaires will not be aware of what group each participant was allocated to (unless the participant mentions it during the questionnaires). Therefore, allocation is concealed to those conducting the questionnaires but not to the researchers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Microsoft Access will be programmed in such a way as to ensure approximately equal numbers of participants will be assigned to each group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
There will be two intervention groups in this study. One group will receive personalised text messages relating to skin protection and the other group will receive personalised messages relating to skin self examination. The attention control group will receive text messages about physical activity.

These messages will be personalised using the participants name and the contents of many of the messages will be determined by the answers provided by the participant during the baseline and three month surveys (for example, a participant who plays football will receive a message encouraging them to wear a hat during a footy game, as opposed to a participant who reports swimming as a main outdoor activity, who will receive a message that suggests wearing sunscreen while swimming).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
735
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 285313 0
Charities/Societies/Foundations
Name [1] 285313 0
Cancer Australia
Country [1] 285313 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] 284170 0
University
Name [1] 284170 0
Dermatology Research Centre, University of Queensland
Address [1] 284170 0
Dermatology Research Centre, The University of Queensland, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba QLD 4102
Country [1] 284170 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287328 0
Queensland University of Technology Research Ethics Committee
Ethics committee address [1] 287328 0
Research Ethics Unit, Office of Research, Level 4, 88 Musk Avenue, QUT Kelvin Grove, Australia, 4059
Ethics committee country [1] 287328 0
Australia
Date submitted for ethics approval [1] 287328 0
20/09/2011
Approval date [1] 287328 0
23/09/2011
Ethics approval number [1] 287328 0
1100000942

Summary
Brief summary
The purpose of this study is to assess the impact of personalised mobile telephone short messages (SMS) on improving skin protection and early skin cancer detection behaviours among young to mid-aged adults (18 to 42 years).

Who is it for?

This study is open to consenting participants aged 18-42 years, understand sufficient English, own a private mobile phone, and who have had no previous melanoma with Fitzpatrick skin types I-III (skin that always, usually or sometimes burns and never or sometimes tans).

Trial details

Participants in this study will be randomised into one of two groups, where both groups will receive a total of 21 personalised text messages over a period of 12 months relating to either sun safety or skin self examination OR in relation to physical activity.

The frequency of these text messages is as follows: One message per week for the first three months of the study, then one message per month for the remaining nine months.

There are two primary hypotheses for this trial: 1) Provision of personalised sun protection SMS will reduce the proportion of intervention group participants reporting two or more sunburns during the past twelve months by at least 15% compared to no change in the attention control group (physical activity SMS).

2) Provision of personalised skin cancer early detection SMS will increase the proportion of intervention participants who report a whole-body skin self-examination in the past twelve months by at least 10% compared to no change in the attention control group (physical activity SMS).

We will also measure satisfaction with, use of, and recall of the SMS messages. The associated secondary hypothesis is that SMS messages are an acceptable and feasible method of reaching people aged 18-42 years with personalised skin cancer prevention messages.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 34217 0
Address 34217 0
Country 34217 0
Phone 34217 0
Fax 34217 0
Email 34217 0
Contact person for public queries
Name 17464 0
Sarah Mair
Address 17464 0
QUT School of Public Health Victoria Park Road Kelvin Grove, QLD, 4059
Country 17464 0
Australia
Phone 17464 0
+617 3138 9674
Fax 17464 0
Email 17464 0
[email protected]
Contact person for scientific queries
Name 8392 0
Dr Mokina Janda
Address 8392 0
QUT School of Public Health Victoria Park Road Kelvin Grove, QLD, 4059
Country 8392 0
Australia
Phone 8392 0
+617 3138 3018
Fax 8392 0
Email 8392 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
Dimensions AIUser preferences for text message-delivered skin cancer prevention and early detection2015https://doi.org/10.1177/1357633x15571652
N.B. These documents automatically identified may not have been verified by the study sponsor.