Table 2.
Schedule of study parameters and collection time points
| 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: | |||||
| 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 | |||
aFollow-up 1 (F1) takes place 1 month after participants receive their booklets. Follow-up 2 (F2) takes place 12 months after participants complete the baseline assessment (baseline questionnaire and ultraviolet radiation (UV) dosimeter)
bThe UV dosimeter measurement will be measured in ~ 240 participants rather than in all participants at the short-term (1-month) follow-up