| Study period | ||||
---|---|---|---|---|---|
Screening/consent | Baseline/randomisation | Intervention delivery | Follow-upa | ||
Time point | -1 | 0 | T1 | F1 | F2 |
Enrolment: | |||||
 Eligibility screen | X |  |  |  |  |
 Informed consent | X |  |  |  |  |
 Allocation |  | X |  |  |  |
Group allocation: | |||||
Intervention arm: | Â | Â | Â | Â | Â |
  Saliva sample |  | X |  |  |  |
  Personalised melanoma genetic risk booklet |  |  | X |  |  |
  Phone call from genetic counsellor |  |  | X |  |  |
  Educational booklet on melanoma preventive behaviours |  |  | X |  |  |
Control arm: | |||||
  Educational booklet on melanoma preventive behaviours |  |  | X |  |  |
Assessments (control and intervention patients): | |||||
  Demographics |  | X |  |  |  |
  Melanoma risk factors |  | X |  |  |  |
  Sun exposure (objective measure) |  | X |  | Xb | X |
  Sun exposure (self-report) |  | X |  | X | X |
  Sun-protection behaviours |  | X |  | X | X |
  Skin examination behaviours |  | X |  | X | X |
  Intentions, beliefs and attitudes towards sun-protection behaviours and skin examinations |  | X |  | X | X |
  Discussion about sun protection and skin examinations with family |  | X |  | X | X |
  Perceived social norms about sun protection and skin examination |  | X |  |  |  |
  Perceived melanoma risk |  | X |  | X | X |
  Skin-cancer related worry |  | X |  | X | X |
  Perceived control over the development and early detection of future melanomas |  | X |  | X | X |
  Risk taking behaviours (Domain-Specific Risk-taking scale (DOSPERT)) |  | X |  |  |  |
  Psychological distress and well-being (MHI-5) |  | X |  | X | X |
  Confidence in completing medical forms |  | X |  |  |  |
  General health |  | X |  |  |  |
  Satisfaction with educational booklet on melanoma preventive behaviours, and amount read by participants |  |  |  | X | X |
  Out-of-pocket costs for sun-protection items |  |  |  | X | X |
  Visits to health care professionals |  |  |  | X | X |
  Private health insurance |  |  |  | X | X |
  Use of medications that may increase risk of melanoma or skin sensitivity to sunlight |  | X |  | X | X |
  Importance of health |  | X |  |  |  |
  Confidence in understanding medical information |  | X |  |  |  |
  Reasons for participating in the study |  | X |  |  |  |
  Receiving advice from health professional regarding sun protection and skin checks |  | X |  | X | X |
  Information seeking about skin cancer and genetics |  | X |  | X | X |
  Use of the study website |  | X |  | X | X |
  Use of applications related to sun protection or skin examinations |  |  |  |  | X |
Measures related to receiving genetic risk information (intervention participants only): | |||||
  Recalling personal genetic risk |  |  |  | X | X |
  Communication with family, friends and health professionals about genetic risk |  |  |  | X | X |
  Motivation and barriers to communication about genetic risk |  |  |  | X | X |
  Satisfaction with genetic risk booklet and genetic counselling |  |  |  | X | X |
  Understanding of genetic risk information, and amount read by participants |  |  |  | X | X |
  Multidimensional impact of cancer risk assessment |  |  |  | X | X |