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XPAND Trial: Enhancing XP Photoprotection Activities - New Directions (XPAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03445052
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
King's College London
Newcastle University
University of Cambridge
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Study Description
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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.


Condition or disease Intervention/treatment Phase
Xeroderma Pigmentosum Behavioral: XPAND Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description:

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.
Primary Purpose: Prevention
Official Title: The XPAND Evaluation of a Personalised Adherence Intervention to Improve Photoprotection Behaviour in Adults With Xeroderma Pigmentosum (XP): Randomised Controlled Trial.
Actual Study Start Date : March 30, 2018
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : January 30, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 2018 XPAND Intervention Arm
This group will receive the personalised adherence intervention in 2018 in addition to routine clinical care.
 Behavioral: XPAND
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.
No Intervention: 2018 XPAND Control Arm
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.


Outcome Measures
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Primary Outcome Measures :
  1. Mean daily dose of ultraviolet radiation (UVR) to the face using a dosimeter and diary. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Mean daily mood [ Time Frame: 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. ]
    This is a self reported measure of mood. It will be measured daily by completion of a single question designed for the study. The question is: How would you describe your mood today? (0= very negative - 10=very positive). Participants respond by marking a number between 0 and 10. A higher score indicates a more positive mood. Mean daily mood will be recorded across each 21 day measurement period for each participant.

  2. Mean daily automaticity of UVR protection activity [ Time Frame: 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. ]
    This is a self reported measure of automaticity. It will be measured daily by completion of a single question designed for the study, adapted from the Self-Report Behavioural Automaticity Index (SRBAI). The question is: How much do you agree that UVR protection of your face today was something you did automatically without thinking? (0=strongly disagree - 10= strongly agree) Participants respond by marking a number between 0 and 10. A higher score indicates greater automaticity. Mean daily automaticity will be recorded across each 21 day measurement period for each participant.

  3. Mean daily prioritisation of UVR protection activity [ Time Frame: 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. ]
    This is a self reported measure of prioritisation of UVR protection activity compared to other activities. It will be measured daily by completion of a single question designed for the study. The question is: How important was UVR protection of your face today compared to other things you wanted/needed to do? (0=not at all - 10=very important)? Participants respond by marking a number between 0 and 10. A higher scores indicates giving protection a higher priority. Mean daily prioritisation will be recorded across each 21 day measurement period for each participant.

  4. Mean daily self-efficacy for UVR protection in the presence of barriers [ Time Frame: 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. ]
    This is a self reported measure of self efficacy for successfully carrying out UVR protection activities in the presence of barriers. It will be measured daily by completion of a single question designed for the study. The question is: How confident are you that you can protect your face well tomorrow, even if other things get in the way? (0=not at all - 10=very much so). Participants respond by marking a number between 0 and 10. A higher score indicates greater self- efficacy. Mean daily prioritisation will be recorded across each 21 day measurement period for each participant.

  5. EuroQoL five dimensions scale (EQ-5D-5L) [ Time Frame: 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. ]
    The EQ-5D is a standardised validated published measure of health related quality of life. It measures 5 dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. There are 5 responses to each domain increasing in severity (no problem to extreme problems for each domain). For each domain a higher score indicates worse health related quality of life in that domain. It also records self-rated health on a visual analogue scale (0-100), with a higher score indicating better health. A single index score can be derived from the domains giving a score between 0-1 (a higher score indicates higher health related quality of life).

  6. 4-item Self-Report Behavioural Automaticity Index (SRBAI) [ Time Frame: 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. ]
    Validated published measure of automaticity of behaviour. It consists of 4 items, where the respondent rates the extent to which they agree with 4 statements related to automaticity and the behaviour (UVR protection) (e.g., UVR protection is something I do automatically (1=strongly disagree - 7=strongly agree). A composite score is the mean of the four items. A higher score indicates greater automaticity.

  7. Short-form Warwick Edinburgh Mental Well-being scale (SWEMWBS) [ Time Frame: 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. ]
    The SWEMWBS is a validated published measure of emotional wellbeing and is composed of 7 items related to a positive aspect of wellbeing (e.g., I've been feeling useful"). Respondents rate how often they have experienced each aspect over the previous 2 weeks (e.g., none of the time rarely, some of the time, often or all of the time) on a scale of 1-5. Scores are summed and then translated to a continuous metric using conversion tables (7-35). A higher score indicates higher levels of emotional wellbeing.

  8. Photoprotection self-efficacy Questionnaire (PSEQ) [ Time Frame: 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. ]
    This was developed for the study. The questionnaire assesses self-efficacy in the context of barriers using 5 items. Three items ask the respondent to rate their level of confidence that they can carry out a type of photoprotection behaviour (shifting timing or duration of outdoor activity, photoprotect using clothing, correctly apply sunscreen) on a 0-10 scale (0=Not at all - 10=very confident). Two items ask about confidence to carry out clothing protection and sunscreen application in the presence of a variety of barriers (e.g., How confident are you that you can photoprotect even if ....you are with new people?). A mean overall self-efficacy score will be calculated.

  9. Brief Photoprotection Adherence Questionnaire (BPAQ) [ Time Frame: 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. ]
    This was developed for the study as a secondary measure of photoprotection behaviour. It has 3 questions assessing frequency of protection over the previous 7 days (e.g., When you went outside, how often did you protect your face against UVR using protective clothing? 0=never - 10=all the time) and 2 questions asking about the amount of time spent out of doors during the day (never, 30 mins or less, up to 8 hours) and during periods when UVR is at its highest (11am-3pm). Items 1 to 3 are summed to give a score between 0-27, where a higher score indicates better photoprotection. Items 4 and 5, are reported individually.

  10. Health Economic evaluation of the intervention [ Time Frame: All participants will complete at baseline and 36 weeks post baseline. Control group will complete this at 21 months (84 weeks) post baseline. ]
    Financial impact of the intervention will be assessed by a questionnaire assessing health service use and the costs of XP to the participant. The questionnaire is an adapted version of the Client Service Receipt Inventory (CSRI). This retrospectively assesses use of primary and secondary healthcare services (including surgical interventions), social care, medication, tests/investigations, and aids and adaptations. Other impacts of XP measured will include time lost from work and education by patients and extra time spent caring by family members.

  11. Mean daily dose of ultraviolet radiation (UVR) to the face using a dosimeter [ Time Frame: It will measured in all participants for 21 days at 16 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.


Other Outcome Measures:
  1. Qualitative evaluation of the intervention from the perspective of the patient [ Time Frame: They will be conducted after the 16 weeks post baseline assessement (intervention group) and post 17 months (control group) ]
    Semi-structured face-to-face interviews will be conducted to explore: i) the psychological mechanisms of change which explain the change in photoprotection behaviour; ii) the acceptability of the intervention from the perspective of the participant. Topics are likely to include: whether/how the intervention changed their beliefs regarding illness/treatment, confidence and motivation to photoprotect, what aspects they liked/disliked, how helpful they found the intervention, how difficult it was to make (and sustain) changes in beliefs and practices.

  2. Self report Intervention Feedback questionnaire [ Time Frame: It will be completed post intervention at 16 weeks follow-up (intervention group) and for the control group at 14.5 months (68 weeks) ]
    This is designed for this study. It has 5 items assessing overall perceptions of the programme and its components, the impact on photoprotection behaviour and whether psychosocial variables have changed as a result of the intervention. The questionnaires assesses the extent to which respondents agree with statements about the intervention (e.g., "Overall the programme was interesting/easy to understand/ helpful" 1=Strongly disagree - 5=Completely agree). A mean score of all the items will give an overall score. A higher score indicates more favourable feedback. The questionnaire will be used to inform the content of the qualitative interviews.

  3. Profiling questionnaire [ Time Frame: 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. ]
    To personalise the intervention for each individual participant, a profiling questionnaire was developed for this study. The questionnaire has 21 items which assess drivers associated with suboptimal adherence to photoprotection. For example "How much do you think XP treatment at the clinic can help your skin or eye health?" (0-not at all, 10-very much). A higher score indicates greater strength of each driver. The pattern of responses will be assessed to ascertain which driver/s are important for each participant. This profile will be used to guide the content of the intervention for each participant.

  4. Hospital Anxiety and Depression Scale (HADs) [ Time Frame: All participants at baseline and at 12 months (52 weeks) for the control group. ]
    Self-reported validated published measure of Anxiety and Depression. It will be used to screen participant for clinical levels of anxiety and depression. It consists of 7 statements about anxiety and 7 about depression. Respondents are asked to indicate their agreement with the statement on a 4 point Likert scale. Scores range between 0 and 21 for each subscale. A score of 11< suggests presence of a mood disorder.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A confirmed diagnosis (on the basis of DNA repair study results) of Xeroderma Pigmentosum
  2. Age >16 years
  3. 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:

  1. Score <20 on the Adherence to Photoprotection scale (total score is 25 - optimal protection) from a cross-sectional questionnaire completed during our previous research.
  2. 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.
  3. Having a "resistant" mode of adjustment to photoprotection in the qualitative analysis

Exclusion Criteria:

  1. Adults diagnosed with cognitive impairment
  2. Adults with inadequate English to be able to converse with the intervention facilitators
  3. Adults diagnosed with current clinical depression or anxiety
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445052


Locations
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United Kingdom
Guy's St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
Newcastle University
University of Cambridge
Investigators
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Principal Investigator: Robert Sarkany, FRCP MD CCST Guy's & St Thomas' Foundation NHS Trust
Principal Investigator: John Weinman, PhD, FbPsS King's College London
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03445052    
Other Study ID Numbers: 236877
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Adherence
Behaviour change
Intervention
Photoprotection
Ultraviolet radiation
Additional relevant MeSH terms:
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Xeroderma Pigmentosum
Ichthyosis
Precancerous Conditions
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Photosensitivity Disorders
Skin Diseases
Pigmentation Disorders
DNA Repair-Deficiency Disorders
Metabolic Diseases
Infant, Newborn, Diseases
Keratosis