A research study about personal genetic risk of melanoma among the general population

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000356561
• Date of registration: 20/04/2015
• Prospective Registration: No
• Primary sponsor: The University of Sydney
• Public title: A research study about personal genetic risk of melanoma among the general population
• Scientific title: Does knowledge of personal genetic risk of melanoma, compared to standard prevention advice, motivate behaviour change among the general population? A pilot randomised controlled trial (RCT)
• Date of first enrolment: 14/04/2015
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000356561.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Anne Cust

• Name: Dr Anne Cust

Key inclusion & exclusion criteria

Inclusion criteria: People aged 18-69 years from the general population, who have never had melanoma (since this study is aimed at prevention), have sufficient English to complete the study questionnaires, and have registered with the Cancer Council NSW 'Join a Research Study' database.
Exclusion criteria: - Outside the eligible age range, insufficient English to complete the study questionnaires, previous melanoma diagnosis.

Age minimum: 18 Years
Age maximum: 69 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Malignant melanoma

melanoma;
melanoma

Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

Intervention(s)

Participants randomised to the intervention arm will receive:
1) Personal information about their melanoma genetic risk.
2) Telephone access to a genetic counsellor;
3) Printed and electronic general educational materials on melanoma preventive behaviours including sun exposure, sun protection and skin examinations.

Determination of genetic risk: From participants’ saliva samples, we will genotype specific variants in 20 genes that have a confirmed association with melanoma risk. All variants will have been identified through adequately powered and replicated large, international studies. Genetic risk estimates for melanoma will be presented both as: 1) an absolute-risk and relative-risk estimate of the participant’s lifetime risk of developing melanoma; and 2) a broad genetic risk level – low, average, high. Participants will not be given their individual genotypes, only the risk estimates derived from them. A person’s lifetime risk of melanoma based on the 20 selected genomic variants will be estimated using published statistical methodology. The calculation assumes a multiplicative model and is based on the person’s genomic variation, the odds ratio for melanoma associated with each variant’s risk allele from replication studies or meta-analyses, the corresponding population frequency of each risk allele, and age- and sex-specific melanoma residual lifetime risk estimates from NSW cancer incidence data.

Communication of information on personal melanoma genetic risk: When it is time to give the participant the information on their personal genetic risk of melanoma, they will be contacted by telephone by the study’s genetic counsellor. At this time, the genetic counsellor will ask whether or not the participant has any questions or concerns and

Primary Outcome(s)

Sun exposure. Measured using time (mins) spent outdoors during peak UV hours (10am-2pm/11am-3pm [depending on daylight savings]) on weekdays and weekends during the past month: "Thinking about the past month, we would like to know the times of day as well as the usual length of time that you spent outside between 9am and 5pm on a typical weekday/Saturday/Sunday. (Participants tick one response: 0,<15,15-29,30-44,45–60 mins; for each 1-hour time period between 9am and 5pm)."

In a 10% random sample of participants, we will objectively measure UV exposure using polysulfone film time-stamped UV dosimeter badges – the gold standard for assessing cumulative and daily personal UV exposure. They will be mounted in custom-made wristbands attached to the left wrist, and worn over 2 weekdays and 2 week-end days, which is sufficient for estimating habitual weekly behaviour.[3-months after delivery of the genetic risk information]

Skin examination (self- or doctor-conducted). Measured as a general skin check of the whole body by oneself, partner or a health professional. "In the past 12 months, have you had your skin checked for skin cancer from head to toe by a health professional? In the past 12 months, have you or a partner examined your entire body, including your back, for skin cancer?" [3-months after delivery of the genetic risk information]

Sun protection. Measured using the sun protection habits index, calculated as the mean of five protective behaviours on a 4-point Likert scale (1=never or rarely, 4=always): "During the past month, when outside, how often did you..... wear sunscreen? wear a shirt with sleeves that covered your shoulders? wear a hat? stay in the shade? wear sunglasses?" [3-months after delivery of the genetic risk information]

Secondary Outcome(s)

Acceptability of the information on personal genetic risk of melanoma, including satisfaction with the written materials including the presentation of the risk information. [Measured by self-report questionnaire 3-months after delivery of the genetic risk information]

Economic aspects arising from the study, including:
* Number visits to the GP and specialist doctors
* Number and type of procedures undertaken for the removal of skin lesions (eg. excisions, biopsies, cryotherapy).
* Patient out-of-pocket costs for the purchase of sun protection materials such as hats, sunscreen or shade cover over the previous month.
* Number of telephone calls with a genetic counsellor for both intervention and control groups, and the length of the calls, so that we can value this item of resource use.
[Measured by self-report questionnaire 3-months after delivery of the genetic risk information. Number of telephone calls and length to be collected during the study.]

Participation rates[Measured during the study based on number invited/consented/completed the study.]

Social issues arising from the study, including:
* sharing of genetic risk information between family and friends
* Satisfaction with the communication process including preferences for the method of disclosure of their lifetime risk information
We will use questions previously developed, tested and widely implemented for skin cancer research
[Measured by self-report questionnaire 3-months after delivery of the genetic risk information]

Uptake and acceptability of telephone genetic counselling.

[Measured by self-report questionnaire 3-months after delivery of the genetic risk information, and as the number of calls received throughout the study.]

Ethical issues arising from the study, including:
* Feelings of genetic ‘destiny’ or fatalism
* How to best communicate genomic risk information to recipients and within families
* If they have any regrets about receiving the information
[Measured by self-report questionnaire 3-months after delivery of the genetic risk information]

Frequency of sunburn recalled over the previous month[Measured by self-report questionnaire 3-months after delivery of the genetic risk information]

Hypothesized mediators of behaviour change, including:
* Perceived risk of developing melanoma
* Perceived severity of melanoma
* Perceived barriers and benefits of genetic testing
* Self-efficacy, including perceived control over developing melanoma, confidence in checking one’s own skin
* Social norms, such as attitudes to tanning and sun protection.
* Health literacy
* Risk taking
[Measured by self-report questionnaire 3-months after delivery of the genetic risk information]

Psychological issues arising from the study, including:
Skin cancer-related worry using 3 items shown to be associated with the frequency of skin self-examination in people without melanoma.
Psychological distress and well-being using the 5-item version of the Mental Health Inventory (MHI-5) designed for primary care settings.
[Measured by self-report questionnaire 3-months after delivery of the genetic risk information]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Sydney Catalyst Translational Cancer Centre pilot and seed funding grant

Ethics review

Status: Approved
Approval date:
Contact:

The University of Sydney Human Research Ethics Committee (HREC)