Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000092392
Ethics application status
Approved
Date submitted
13/01/2017
Date registered
17/01/2017
Date last updated
17/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the impact of a web-based melanoma awareness video on intentions to engage in sun protection among a sample of young Australians.
Scientific title
Investigating the impact of a web-based melanoma awareness video and a melanoma self risk assessment on sun protection intentions and related cognitive processes among a sample of young Australians: A randomized controlled trial
Secondary ID [1] 290885 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma risk 301597 0
Condition category
Condition code
Public Health 301304 301304 0 0
Health promotion/education
Cancer 301356 301356 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study investigated the impact of the melanoma awareness video ‘Dear 16-year-old me’, a self-assessment of perceived melanoma risk, and a control condition.

'Dear 16-year-old me" is a five minute melanoma awareness video developed by the David Cornfield Melanoma Fund in 2011, which is available online. The video addresses the importance of protecting and checking one’s skin via personal testimonies from real life melanoma survivors and their families, who share with their younger selves the advice that could have prevented them or a loved one from developing melanoma.

The risk self-assessment used in this study was one component of a self-administered melanoma questionnaire that assesses personal risk, level of concern, protective behaviour, and knowledge (Gillespie et al., 2011). For the purpose of this study, only the risk component of the questionnaire was used (the Personal Risk for Melanoma Questionnaire; PRMQ). This 7-item self-assessment collects information about skin type, hair colour, and other personal factors that can contribute to an individual’s likelihood of developing melanoma. Each response attracts a score, and the sum of these is a numerical indication of melanoma risk, ranging on a scale from -2 to 22.
Intervention code [1] 296830 0
Prevention
Intervention code [2] 296831 0
Lifestyle
Intervention code [3] 296832 0
Behaviour
Comparator / control treatment
The control condition was an educational Cancer Council South Australia webpage featuring information about skin cancer prevention.
Control group
Active

Outcomes
Primary outcome [1] 300715 0
Intended sun protection behaviours were measured using the Sun Protection Behaviours Scale (Weinstock et al., 2000), with two items modified to include SPF 30+ specifications, Participants rated how often they intended to engage in 10 sun protection behaviors (e.g., “Wear a hat”) when out in the sun next summer on a 5-point scale ranging from 1 = never to 5 = always.
Timepoint [1] 300715 0
Follow-up (2 weeks)
Primary outcome [2] 300716 0
Skin cancer fear was measured using 8 items adapted from the Breast Cancer Fear Scale (Champion et al., 2004), which assesses the extent of cancer-specific fear. Participants rated their agreement with statements regarding their beliefs about skin cancer skin cancer (e.g., “The thought of skin cancer scares me”) on a 5-point scale ranging from 1 = strongly disagree to 5 = strongly agree.
Timepoint [2] 300716 0
Follow-up (2 weeks)
Primary outcome [3] 300717 0
Perceived threat of skin cancer was assessed using three perceived severity items and three perceived susceptibility items from the Risk Behavior Diagnosis Scale (Witte, 1996). Responses were averaged to create an overall index. Participants rated their agreement with statements about the severity of skin cancer (e.g., “I believe skin cancer is severe”) and their susceptibility (e.g., “I am likely to contract skin cancer”) on a scale ranging from 1 = strongly disagree to 5 = strongly agree.
Timepoint [3] 300717 0
Follow-up (2 weeks)
Secondary outcome [1] 330688 0
Intended sun protection behaviours were measured using the Sun Protection Behaviours Scale (Weinstock et al., 2000), with two items modified to include SPF 30+ specifications, Participants rated how often they intended to engage in 10 sun protection behaviors (e.g., “Wear a hat”) when out in the sun next summer on a 5-point scale ranging from 1 = never to 5 = always.
Timepoint [1] 330688 0
Post-intervention, at completion of either viewing "Dear 16-year-old me", completing the PRMQ, or exposure to the control condition.
Secondary outcome [2] 330689 0
Skin cancer fear was measured using 8 items adapted from the Breast Cancer Fear Scale (Champion et al., 2004), which assesses the extent of cancer-specific fear. Participants rated their agreement with statements regarding their beliefs about skin cancer skin cancer (e.g., “The thought of skin cancer scares me”) on a 5-point scale ranging from 1 = strongly disagree to 5 = strongly agree.
Timepoint [2] 330689 0
Post-intervention, at completion of either viewing "Dear 16-year-old me", completing the PRMQ, or exposure to the control condition.
Secondary outcome [3] 330690 0
Perceived threat of skin cancer was assessed using three perceived severity items and three perceived susceptibility items from the Risk Behavior Diagnosis Scale (Witte, 1996). Responses were averaged to create an overall index. Participants rated their agreement with statements about the severity of skin cancer (e.g., “I believe skin cancer is severe”) and their susceptibility (e.g., “I am likely to contract skin cancer”) on a scale ranging from 1 = strongly disagree to 5 = strongly agree.
Timepoint [3] 330690 0
Post-intervention, at completion of either viewing "Dear 16-year-old me", completing the PRMQ, or exposure to the control condition.

Eligibility
Key inclusion criteria
Young adults residing in Australia and fluent in English.
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current skin cancer diagnosis.

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)
Central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A series of 3 (Group: "Dear 16 year-old-me", PRMQ, control) × 3 (Time: baseline, post-intervention, follow-up) between-within subjects analyses of variance (ANOVA) were conducted to determine the impact of the intervention materials on perceived threat, fear, and intended sun protection scores. A Bonferroni adjusted alpha level of .017 was employed to account for multiple comparisons. Post hoc analyses using the LSD post hoc criterion for significance were used to determine differences between groups.
Power analysis was conducted prior to the study in order to estimate the required sample size. To attain a desired power of .80 or above for a corrected alpha level of .017 and a small effect size (ES = .3), a total sample of n=147 was necessary. On the basis of 50 respondents per condition, the current sample of n=222 at baseline and n=187 at follow-up was adequate to conduct analyses of variance with effects of small size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/06/2013
Date of last participant enrolment
Anticipated
Actual
2/08/2013
Date of last data collection
Anticipated
Actual
30/08/2013
Sample size
Target
150
Accrual to date
Final
222
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 295320 0
Charities/Societies/Foundations
Name [1] 295320 0
Cancer Council South Australia
Country [1] 295320 0
Australia
Funding source category [2] 295343 0
University
Name [2] 295343 0
University of Adelaide
Country [2] 295343 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
School of Psychology
Faculty of Health Sciences
University of Adelaide
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 294168 0
None
Name [1] 294168 0
Address [1] 294168 0
Country [1] 294168 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296651 0
University of Adelaide Ethics Committee
Ethics committee address [1] 296651 0
The University of Adelaide
Research Branch
Adelaide SA 5005
Ethics committee country [1] 296651 0
Australia
Date submitted for ethics approval [1] 296651 0
Approval date [1] 296651 0
23/05/2013
Ethics approval number [1] 296651 0

Summary
Brief summary
This was the first study to investigate empirically the impact of the online melanoma awareness video, ‘Dear 16-year-old me’, on sun protection intentions and related cognitive processes in young adults aged 17-30. We examined changes in perceived threat, skin cancer fear, and intention to participate in a variety of sun protection behaviors after exposure to ‘Dear 16-year-old me’, the personal risk for melanoma questionnaire (PRMQ), or an informational control condition. It was anticipated that: (1) participants exposed to ‘Dear 16-year-old me’ or the PRMQ would demonstrate significant improvements in perceived threat, skin cancer fear, and sun protection intentions post-intervention, (2) participants in the control condition would not demonstrate any significant changes in perceived threat, skin cancer fear, or sun protection intentions post-intervention, (3) all significant effects would be maintained two weeks later at follow-up. A mixed within-between subjects design was used. Participants were randomly allocated to one of three experimental conditions: ‘Dear 16-year-old me’, PRMQ, control) and completed an online questionnaire at three time points (baseline, post-intervention, two-week follow-up).Data were obtained from 222 participants (158 female) at baseline and 187 at follow-up. There was a significant interaction between group and time for intended sun protection behaviors and perceived threat, with participants exposed to ‘Dear-16-year-old me’ reporting the greatest improvements. Heightened perceptions of threat among participants exposed to ‘Dear 16-year-old me’ were maintained at follow-up, although increased levels of skin cancer fear were not. Sun protection intentions increased across all groups over time, but this increase was significantly greater in the intervention groups than the control group. The results suggest that ‘Dear 16-year-old me’ is a promising intervention for reducing skin cancer risk among young adults. The study findings support the assertion that providing people with narrative evidence from other “real” people can be an effective strategy to increase perceptions of personal health risk and encourage health protective behavior.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1366 1366 0 0
/AnzctrAttachments/372143-Consent form.docx

Contacts
Principal investigator
Name 71630 0
Ms Imogen Ramsey
Address 71630 0
School of Nursing and Midwifery
Division of Health Sciences
City East Campus Playford Building P4-27C
University of South Australia
North Terrace
Adelaide SA 5000
Country 71630 0
Australia
Phone 71630 0
+61 4 21971446
Fax 71630 0
Email 71630 0
[email protected]
Contact person for public queries
Name 71631 0
Ms Imogen Ramsey
Address 71631 0
School of Nursing and Midwifery
Division of Health Sciences
City East Campus Playford Building P4-27C
University of South Australia
North Terrace
Adelaide SA 5000
Country 71631 0
Australia
Phone 71631 0
+61 4 21971446
Fax 71631 0
Email 71631 0
[email protected]
Contact person for scientific queries
Name 71632 0
Ms Imogen Ramsey
Address 71632 0
School of Nursing and Midwifery
Division of Health Sciences
City East Campus Playford Building P4-27C
University of South Australia
North Terrace
Adelaide SA 5000
Country 71632 0
Australia
Phone 71632 0
+61 4 21971446
Fax 71632 0
Email 71632 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
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Documents added automatically
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