The XPAND Evaluation of a Personalised Adherence Intervention to Improve Photoprotection Behaviour in Adults With Xeroderma Pigmentosum (XP): Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mean daily dose of ultraviolet radiation (UVR) to the face using a dosimeter and diary.
研究概览
简要总结
People with Xeroderma Pigmentosum (XP) have a genetic condition which stops their skin repairing damage from Ultraviolet Radiation (UVR). This means they are much more likely to develop potentially fatal skin cancers. The only way to reduce this damage is to rigorously protect the skin, by limiting UVR exposure. This done in a number of ways including: staying indoors; wearing protective clothing, sunscreen and glasses. People with XP can find it difficult to maintain this level of protection, putting themselves at risk.
This research will test whether an intervention designed to enhance photoprotection activities is successful. It will use a randomised controlled trial design to compare the amount of UVR reaching the face, between participants receiving the intervention and those receiving standard clinical care. The amount of UVR reaching the face is important, as this is where people with XP develop most cancers. It is dependent on the overall level of exposure to UVR in the environment, and photoprotection used.
The intervention involves a tailored conversation with the participant about their photoprotection practices. It will target both the overall exposure to UVR and the photoprotection used when outdoors, and will be conducted in 7 sessions with an intervention facilitator. The content will be dependent on the specific photoprotection behaviour being targeted (e.g., poor sunscreen application) and the reasons for poor photoprotection for each person. This could be low motivation related to doubts about the need to protect and concerns about protecting. Other barriers to protection might be lack of routines. The facilitator will provide information tailored to these beliefs and use other standard behaviour change techniques to encourage the development of "better" photoprotection habits.
The investigators predict that the intervention group will have a lower mean daily dose of UVR to the face compared to the control group in two time periods in the summer months.
详细描述
Xeroderma Pigmentosum (XP) is a rare autosomal recessive inherited condition caused by defective Nucleotide Excision Repair. Patients may develop skin cancers from childhood onwards, ocular damage, and neurological deterioration. The clinical management of XP relies on minimising exposure of the skin to Ultraviolet radiation (UVR), which is the only means of preventing skin cancer and eye disease. Reduction in UVR exposure is achieved by a combination of lowering overall exposure and rigorously photoprotecting when outdoors. This involves wearing protective clothing and application of factor 50 sunscreen to any exposed skin. Evidence from new research carried out by our team, indicated that photoprotection was inadequate with room for improvement. The clinical consequence of this sub-optimal photoprotection is higher incidence of skin cancers, including malignant melanoma, which require surgery and can be life threatening.
The investigators have designed a personalised adherence intervention, using a systematic approach called Intervention Mapping, to target the determinants of UVR reaching the face. The intervention will not require advanced therapeutic skills and has been designed to be delivered by a range of healthcare professionals. It will be tailored to the predictors of photoprotection, relevant for each person, and will be delivered via seven one-to-one sessions between the intervention facilitator and patient. Sessions 1 and 6 will be delivered face to face in the home and the remaining sessions will be conducted via telephone calls or skype sessions, depending on the preference of the participant. The facilitator will use a range of behaviour change techniques to target each determinant relevant to each individual, alongside generic components to promote habit and planning which will be delivered to all. Personalised text messages, sunscreen application video and activity sheets will also be used. The intervention facilitator will use the collaborative conversational style of Motivational Interviewing.
The primary objective is to test the efficacy of a personalised adherence intervention to reduce the level of UVR reaching the face by improving adherence to UVR protection advice.
Primary objective
- To compare the mean daily dose of UVR (SEDs) reaching the face between the intervention group and control group over a 3 week period in June to July (follow-up 1) Secondary objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Group Allocation will be concealed from the statisticians conducting the analysis until the analysis relevant to the primary study objective has been completed.
Care providers: Group allocation will be concealed from the XP clinical team who are not part of the research team. This is to avoid change in the standard care of these participants during the trial (i.e., greater/less discussion of adherence to photoprotection during the routine clinical appointment). Randomisation will be broken if the intervention facilitator is concerned about the participant's emotional wellbeing at any point during delivering the intervention. In this case the clinical team will be alerted and the participant will be referred to the clinical psychologist at the XP service for assessment.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis (on the basis of DNA repair study results) of Xeroderma Pigmentosum
- •Age >16 years
- •Sub-optimal adherence to photoprotection when outdoors, identified by clinical team from data held in medical notes.
- •For those who participated in our previous research study, sub-optimal adherence will be confirmed from data collected during that study. They will be eligible if they meet any of the following criteria:
- •Score <20 on the Adherence to Photoprotection scale (total score is 25 - optimal protection) from a cross-sectional questionnaire completed during our previous research.
- •Using photoprotective clothing that have been assessed by the clinical team as anything other than "very good or excellent" on anytime outdoors, recorded on the daily UVR protection diary.
- •Having a "resistant" mode of adjustment to photoprotection in the qualitative analysis
排除标准
- •Adults diagnosed with cognitive impairment
- •Adults with inadequate English to be able to converse with the intervention facilitators
- •Adults diagnosed with current clinical depression or anxiety
结局指标
主要结局
Mean daily dose of ultraviolet radiation (UVR) to the face using a dosimeter and diary.
时间窗: It will measured in all participants for 21 days at 10 weeks post baseline
The mean daily dose of UVR will be calculated by combining data from: (i) A UVR recorder wrist-worn device, (dosimeter) (ii) Patients' photoprotective activities self-monitored and recorded on a diary. The dosimeter provides real-time measurements of ambient UVR. It measures UVR in units of Standard Erythemal Dose (SEDs), every 5 seconds and records the mean every 5 minutes. The diary has a grid format with the day split into 15 minute segments. Participants record time spent outside rounded to the nearest 15 minutes and their photoprotection activity (e.g. hat, hoodie worn-up) during that time. During each 15 minute interval the dose of UVR to the face (in SEDs) equals the UVR exposure recorded by the dosimeter weighted by the protection associated with photoprotection behaviours recorded for that interval on the diary. Weights will be generated based on the degree of photoprotection afforded by each activity.
次要结局
- Mean daily mood(It will measured in all participants for 21 days at 3 time periods: baseline, 10 weeks and 16 weeks post baseline. The control group will complete a 21 day follow-up at 12 months (52 weeks) and 14.5 months (62 weeks) post baseline.)
- Mean daily automaticity of UVR protection activity(It will measured in all participants for 21 days at 3 time periods: baseline, 10 weeks and 16 weeks post baseline. The control group will complete a 21 day follow-up at 12 months (52 weeks) and 14.5 months (62 weeks) post baseline.)
- Mean daily prioritisation of UVR protection activity(It will measured in all participants for 21 days at 3 time periods: baseline, 10 weeks and 16 weeks post baseline. The control group will complete a 21 day follow-up at 12 months (52 weeks) and 14.5 months (62 weeks) post baseline.)
- Mean daily self-efficacy for UVR protection in the presence of barriers(It will measured in all participants for 21 days at 3 time periods: baseline, 10 weeks and 16 weeks post baseline. The control group will complete a 21 day follow-up at 12 months (52 weeks) and 14.5 months (62 weeks) post baseline.)
- EuroQoL five dimensions scale (EQ-5D-5L)(This will be measured on single occasions: baseline, 10 weeks, 16 weeks, 36 weeks post baseline. The control group will complete follow-up at 12 months (52 weeks),14.5 months (62 weeks) and 21 months (84 weeks) post baseline.)
- 4-item Self-Report Behavioural Automaticity Index (SRBAI)(This will be measured on single occasions: baseline, 10 weeks, 16 weeks, 36 weeks post baseline. The control group will complete follow-up at 12 months (52 weeks),14.5 months (62 weeks) and 21 months (84 weeks) post baseline.)
- Short-form Warwick Edinburgh Mental Well-being scale (SWEMWBS)(This will be measured on single occasions: baseline, 10 weeks, 16 weeks, 36 weeks post baseline. The control group will complete follow-up at 12 months (52 weeks),14.5 months (62 weeks) and 21 months (84 weeks) post baseline.)
- Photoprotection self-efficacy Questionnaire (PSEQ)(This will be measured on single occasions: baseline, 10 weeks, 16 weeks, 36 weeks post baseline. The control group will complete follow-up at 12 months (52 weeks),14.5 months (62 weeks) and 21 months (84 weeks) post baseline.)
- Brief Photoprotection Adherence Questionnaire (BPAQ)(This will be measured on single occasions: baseline, 10 weeks, 16 weeks, 36 weeks post baseline. The control group will complete follow-up at 12 months (52 weeks),14.5 months (62 weeks) and 21 months (84 weeks) post baseline.)
- Health Economic evaluation of the intervention(All participants will complete at baseline and 36 weeks post baseline. Control group will complete this at 21 months (84 weeks) post baseline.)
- Mean daily dose of ultraviolet radiation (UVR) to the face using a dosimeter(It will measured in all participants for 21 days at 16 weeks post baseline)