None listed
Conditions
Brief summary
The aim of this study is to determine whether the provision of sunscreen pump packs with personalised prescription labels, toothpaste tubes, and personally labelled containers to store toothpaste and sunscreen together, in combination with written, illustrated information about facial sun protection, will improve adherence with daily sunscreen application for patients with a high risk of developing skin cancers over 3 months. Who is it for? You may be eligible for this study if you are an adult patient who has had a history of at least histologically confirmed 2 skin cancers (melanoma, basal cell carcinoma, squamous cell carcinoma, squamous cell carcinoma in situ) within the past 5 years. Study details Participants will be randomly allocated to either a control or intervention arm. Participants in the intervention arm will receive sunscreen and a personalised prescription label attached. Participants in the intervention arm will also receive toothpaste and a personalised prescription-labelled plastic container to hold the sunscreen and toothpaste together. The intervention group will also receive verbal and colour-illustrated written information advising daily use of facial sunscreen each morning after toothbrushing. Participants in the control group will receive identical sunscreen only (without a prescription label) and verbal information to apply sunscreen to their face every morning after toothbrushing. It is hoped that the findings from this study will show that linking sunscreen application on the face with an established morning habit (brushing teeth),and emphasising the medical need for facial sunscreen in this high risk group, will enhance adherence and facilitate habit formation within three months.
Interventions
Participants randomised to the intervention group will receive sunscreen (1 x 50mL pump pack of Cancer Council Hydrating Serum SPF50+; ingredients: Homosalate 10%, Octyl Salicylate 5%, Butyl Methoxydibenzoylmethane 3%, benzotrizinol 3%, Ethylhexyl Triazone 3%, Phenylbenzimidazole sulfonic acid 1.5%w/w) with a personalised prescription label attached. Participants in the intervention arm will also receive toothpaste (Colgate Total Active Prevention Original Toothpaste 115g), and a personalised
Participants randomised to the intervention group will receive sunscreen (1 x 50mL pump pack of Cancer Council Hydrating Serum SPF50+; ingredients: Homosalate 10%, Octyl Salicylate 5%, Butyl Methoxydibenzoylmethane 3%, benzotrizinol 3%, Ethylhexyl Triazone 3%, Phenylbenzimidazole sulfonic acid 1.5%w/w) with a personalised prescription label attached. Participants in the intervention arm will also receive toothpaste (Colgate Total Active Prevention Original Toothpaste 115g), and a personalised prescription-labelled plastic container to hold the sunscreen and toothpaste together. The intervention group will also receive verbal and colour-illustrated written information advising daily use of facial sunscreen each morning after toothbrushing. Verbal information will be delivered in a 5-15 minute face-to-face meeting with the researcher at baseline. Participants will be instructed to store their sunscreen and toothpaste next to each other in the bathroom and apply sunscreen to their face each morning. The personalised prescription label on the sunscreen will include the participant's name, participant ID and the instructions, "Apply TWO pumps once daily to the face in the morning when you brush your teeth. For more intense or prolonged sun exposure, reapply sunscreen 2 hourly during the day." The personalised prescription-labelled plastic container will have the patient's name, date of birth and directions stating, "Apply 2 pumps to your face every morning when you brush your teeth." There will also be prescautions stating, "For more intense or prolonged sun exposure, reapply sunscreen 2 hourly during the day." Strategies used to monitor adherence to the intervention include weighing the sunscreen bottle at the month-3 visit and review of participants' sunscreen diary, which has been developed as a tool for participants to record their facial sunscreen use.
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older 2. History of at least two histologically confirmed primary skin cancers (melanoma, basal cell carcinoma, squamous cell carcinoma, squamous cell carcinoma in situ) within the past 5 years. Histology to be confirmed by an investigator. 3. Willingness and ability to provide informed consent and willingness to participate and comply with the study requirements.
Exclusion criteria
1. History of cutaneous reaction (e.g. allergic dermatitis, photocontact dermatitis) following the use of the study sunscreen product or severe reaction to any sunscreen product 2. Unable to follow up for the duration of the study due to frailty, geographical or social reasons 3. Does not use toothpaste/ does not brush teeth each morning (e.g. has dentures) 4. Already moderate to high adherence with sunscreen use on the face (= 4 days per week) 5. Field treatment for actinic keratoses (topical use of 5 fluorouracil, imiquimod, diclofenac, retinoids; topical photodynamic therapy for actinic keratoses; laser resurfacing or chemical peel treatments for AKs) within the previous 4 weeks. 6. Commenced agents which reduce actinic keratoses (including oral retinoids, oral nicotinamide) within 4 weeks of study commencement. Participants already taking these agents >4 weeks before commencement can continue; participants should not commence these agents during the 3 months of the study.
Outcome results
None listed