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Table 2 Schedule of study parameters and collection time points

From: The Melanoma Genomics Managing Your Risk Study randomised controlled trial: statistical analysis plan

 

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

  1. 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)
  2. bThe UV dosimeter measurement will be measured in ~ 240 participants rather than in all participants at the short-term (1-month) follow-up