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XPAND
The XPAND Evaluation of a Personalised Adherence Intervention to Improve Photoprotection Behaviour in Adults With Xeroderma Pigmentosum (XP): Randomised Controlled Trial.
Sponsor study identifier
interventional
15
1 country
1
Study Start
March 30, 2018
Actual (reported)Primary Completion
December 30, 2019
Actual (reported)Study Completion
January 30, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 7, 2018
Actual (reported)February 26, 2018
Actual (reported)March 30, 2018
Actual (reported)December 30, 2019
Actual (reported)January 30, 2020
Actual (reported)Mean daily dose of ultraviolet radiation (UVR) to the face using a dosimeter and diary.
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.
It will measured in all participants for 21 days at 10 weeks post baseline
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)
Qualitative evaluation of the intervention from the perspective of the patient
They will be conducted after the 16 weeks post baseline assessement (intervention group) and post 17 months (control group)
Self report Intervention Feedback questionnaire
It will be completed post intervention at 16 weeks follow-up (intervention group) and for the control group at 14.5 months (68 weeks)
Profiling questionnaire
At baseline, 36 weeks post baseline. Control group will complete at 12 months (52 weeks) and 21 months (84 weeks) post baseline. Individual items will be used during qualitative interview.
This group will receive the personalised adherence intervention in 2018 in addition to routine clinical care.
This group will receive routine clinical care and act as the control group for the 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). This group will receive the intervention in 2019, to allow within group change to be assessed.
The intervention is personalised to the psychosocial factors influencing poor photoprotection for each person. These factors could include beliefs that reduce motivation to protect as well as factors that prevent intentions being translated into action. The facilitator will use behaviour change techniques to target the factor most important for each person. Standardised content related to habit formation will be received. The intervention will be delivered via 7 1:1 sessions with a facilitator (psychologists or clinical nurse specialist). Sessions 1 (1.5 hours maximum) and 6 (45 minutes) will be delivered face to face in the home of the participant and the remaining sessions will be conducted via telephone calls or skype sessions.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Guy's St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
Walburn J, Sarkany R, Norton S, Foster L, Morgan M, Sainsbury K, Araujo-Soares V, Anderson R, Garrood I, Heydenreich J, Sniehotta FF, Vieira R, Wulf HC, Weinman J. An investigation of the predictors of photoprotection and UVR dose to the face in patients with XP: a protocol using observational mixed methods. BMJ Open. 2017 Aug 21;7(8):e018364. doi: 10.1136/bmjopen-2017-018364.
Walburn J, Norton S, Sarkany R, Sainsbury K, Araujo-Soares V, Morgan M, Canfield M, Foster L, Heydenreich J, McCrone P, Mander A, Sniehotta FF, Wulf HC, Weinman J. Evaluation of a personalised adherence intervention to improve photoprotection in adults with Xeroderma Pigmentosum (XP): protocol for the trial of XPAND. BMJ Open. 2019 Jul 17;9(7):e028577. doi: 10.1136/bmjopen-2018-028577.
Robert Sarkany, FRCP MD CCST
Guy's and St Thomas' NHS Foundation Trust
John Weinman, PhD, FbPsS
King's College London
15 participants (actual enrollment reported by the registry).
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.
Contact the study team to confirm eligibility.
First Submitted
February 7, 2018
First Posted
February 26, 2018
Study Start
March 30, 2018
Actual (reported)Primary Completion
December 30, 2019
Actual (reported)Study Completion
January 30, 2020
Actual (reported)Last Updated
July 22, 2020
Record last verified: 2020-07
There is no plan to make participant data available to other researchers.
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Source: ClinicalTrials.gov.
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