XPAND Trial: Enhancing XP Photoprotection Activities - New Directions

NCT03445052 | Completed DMC

• 1 other identifier: 236877
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Xeroderma Pigmentosum

Keywords

Adherence; Behaviour change; Intervention; Photoprotection; Ultraviolet radiation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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.

Other Outcomes (4)

• 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.

Study Arms (2)

2018 XPAND Intervention Arm

EXPERIMENTAL

This group will receive the personalised adherence intervention in 2018 in addition to routine clinical care.

Behavioral: XPAND

2018 XPAND Control Arm

NO INTERVENTION

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.

Interventions

XPAND BEHAVIORAL

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.

2018 XPAND Intervention Arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator
• Newcastle University: collaborator
• University of Cambridge: collaborator

Study Sites (1)

Guy's St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28827277 BACKGROUND

• 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.

  PMID: 31320353 DERIVED

MeSH Terms

Conditions

Xeroderma Pigmentosum

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Photosensitivity Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Pigmentation Disorders; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Robert Sarkany, FRCP MD CCST

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• John Weinman, PhD, FbPsS

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will test the efficacy of the intervention using a randomised controlled trial design. It is a "delayed RCT", one group will receive the intervention in year 1 and be compared to the other "control group" in year 2. The control group will receive the intervention in year 2. The UVR dose to the face will be measured at baseline (21 days in March -April 2018) and will then be assessed at two follow-up periods in 2018 (June to July; August to September); two periods in 2019 (delayed intervention group). Psychosocial constructs will be measured by self report questionnaires at baseline and at the start of each UVR measurement period, as well as daily during these episodes. 9 months after baseline self-report questionnaires will be completed. A qualitative process evaluation will be conducted after the intervention is complete. A health economic evaluation of the intervention will be assessed by completion of HRQOL and service use questionnaires in December 2018, 2019.

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 26, 2018
• Study Start: March 30, 2018
• Primary Completion: December 30, 2019
• Study Completion: January 30, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)