Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

This arm will receive 15 motivational SMS about cervical cancer and screening.

This arm will receive a voucher covering return transport from the screening clinic. This arm will also receive identical 15 motivational SMS about cervical cancer and screening as the Motivational SMS arm.

This arm will receive standard sensitization during study period (church announcements, screening promotion by key community leaders and posters in community, as well as sensitization by the research assistants conducting the door-to-door household recruitment) during the study and follow-up period. They will also receive one SMS message with the location of screening services during the study period. At the conclusion of the study, participants in the arm will receive identical motivational SMS as the other two arms.

Behaviour change messages delivered via SMS developed with the theoretical guidance of the Health Belief Model.

Motivational SMS

A code for return public transportation to closest cervical cancer screening clinic included in the research.

Travel Voucher

Karen Yeates, MD

The purpose of this study is to determine whether motivational text messages and/or travel vouchers are effective in increasing cervical cancer screening rates in urban and rural regions of Northern Tanzania.

Introduction:

Cervical cancer is the leading cause of cancer-related deaths in Tanzania. The age-adjusted incidence rate is estimated to be 54 cases per 100,000 (IARC, 2012) and 80% of Tanzanian women affected by cervical cancer will die due to advanced stage at diagnosis (Kahesa, et al., 2012). Visual Inspection of the cervix under Acetic Acid (VIA) is an effective alternative to the Pap smear, unavailable in most low-resource countries due to weak health systems (Palanuwong, 2007). Nurses typically receive 6 days of training before returning to their communities to provide VIA; however, they often face a total lack of oversight to ensure they are providing quality screening and cryotherapy. This lack of quality control has prevented a decline in cervical cancer morbidity and mortality despite significant investment and implementation of VIA programs.

The Kilimanjaro Cervical Cancer Screening Project (KCCP) is a pilot study of 1000 women that developed and tested a cervicography (taking a digital photo of the cervix) training method using a smartphone camera in the hands of nurses performing cervical cancer screening and receiving 'real time' mentorship through a closed user group of image transfer and guidance by cervicographers located elsewhere in Tanzania. A pilot study completed in February 2015 showed that this method provides safe and high quality screening and the method is moving to implementation and scale up within multiple VIA programs in late 2015 (Yeates et al., Manuscript in preparation). The KCCP continues to screen patients and this provides a significant opportunity to perform further research that will inform the scale-up program.

Measures to encourage increased uptake of cervical cancer screening in the region, and in many low-resource contexts are drastically needed to reduce the burden of cervical cancer in these contexts. The prevalence of screening in the Kilimanjaro is 6%(Cunningham et al, 2015), which is close to the WHO figure of 5% of women in developing countries having been screened in the last five years (World Health Organization, 1986). The largest perceived barriers to cervical cancer screening in the Kilimanjaro region were found to be a lack of knowledge that screening services were available and women anticipated that they would not be able to afford the costs associated with screening, including travel (Cunningham et al, 2015).

Objectives:

A) To determine attitudes, barriers and enablers towards smartphone cervicography to ensure an accessible, culturally relevant smartphone cervicography screening program

B) To evaluate the impact of a voucher for return transportation towards increasing cervical cancer screening attendance

C) To evaluate the impact of motivational text messages towards increasing cervical cancer screening attendance

Methodology:

This study will comprise of a descriptive cross-sectional survey and a randomized controlled trial (RCT). Household surveys, capturing baseline characteristics, using stratified systematic random sampling in urban and rural areas will be used to recruit participants for the RCT. Cross-sectional survey participants will be recruited opportunistically at screening clinics associated with the study.

RCT participants will be randomized into one of three arms. The first arm will be a control group and will not receive any correspondence. The second arm will receive a series of motivational text messages, including screening dates and locations. The third group will receive a travel voucher code via SMS and motivational text messages with the same content as the second group.

A post-screening survey will be conducted following cervical cancer screening at clinics participating in the study to evaluate screening attendance and attitudes towards smartphone digital cervicography.

The participants were not aware of which group they were randomized to. The care provider providing the screening service was not aware of the group of the participant.

Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania

The primary outcome is binary. It is whether or not participants attend cervical cancer screening at the clinics included in the randomized controlled trial.

The secondary outcome is measured by two survey questions that were part of a exit-survey completed women following cervical cancer screening using the Smartphone Enhanced Visual Inspection with Acetic Acid (SEVIA) used at the two screening clinics included in our trial. The client is considered satisfied if they answer "Yes" to the question "Did you feel comfortable with having a photo of your cervix taken at screening?" and "Definitely Agree" or "Agree" to the question "Did reviewing the picture of your cervix at screening and using it to discuss your risks for cancer increase your knowledge of your risk of cancer?". Otherwise the client is considered dissatisfied.

Terry Fox Foundation

Queen's University

Principal Investigator

Behaviors and Mental Disorders

Quality of Life

Group will receive physical activity information targeted to young adult cancer survivors

Group will receive the Canadian Public Health Guidelines

Stride to Survive:An Exercise Guide for Young Adult Cancer Survivors

Canadian Physical Activity Guidelines

Young adult cancer survivors (YACS) are an understudied group in cancer survivorship research that have unique psychosocial, medical and survivorship issues. Physical activity (PA) has important effects on health-related outcomes in middle-aged and older cancer survivors and preliminary research suggests similar benefits in YACS (18-39 years). Unfortunately, only about half of YACS report meeting public health PA guidelines and there are no interventions or resources available to help YACS increase their PA. The purpose of this study is to test a physical activity guidebook that was developed for YACS based on the theory of planned behavior (TPB). The PA guidebook will be evaluated in a randomized controlled trial. Specifically, 300 YACS will be randomly assigned to (a) Canada's PA guidelines for adults or (b) the YACS PA guidebook. YACS will complete assessments of PA, quality of life, and psychosocial variables at baseline (prior to randomization), 1 month, and 3 months. The primary endpoint in the trial will be change in self-reported PA minutes from baseline to 3 months. Secondary endpoints will include changes in TPB constructs and quality of life. It is hypothesized that the group receiving the YACS PA guidebook (TARG) will report a greater increase in PA minutes compared to the group receiving Canada's PA guidelines (CPAG).

Targeted Vs Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors

Effects of Targeted Versus Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors: A Randomized Control Trial

University of Alberta

Digestive System Diseases

Fatigue

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The intervention group follows a six-month personalized lifestyle program to increase adherence to the World Cancer Research Fund cancer prevention guidelines on healthy nutrition, physical activity and healthy weight.

The wait-list usual care group follows usual care and usual activities. Participants receive a lifestyle program after the intervention period of six months: this includes two personalized behavioural coaching sessions and any material that the intervention group also received.

Participants in the intervention group receive personalized coaching from a lifestyle coach on adhering to the World Cancer Research Fund cancer prevention guidelines. The lifestyle coach is specialized in behaviour change techniques and uses these as the core of the lifestyle coaching. For each participant behavioural determinants will be assessed and targeted with specific applicable behaviour change techniques.

Behaviour change guided lifestyle intervention

The SoFiT study is a randomized controlled trial examining the effects of a behaviour change guided lifestyle intervention on increasing adherence to the World Cancer Research Fund cancer prevention guidelines, compared to the wait-list usual care group, on diminishing cancer-related fatigue in colorectal cancer survivors.

The SoFiT study is a randomized controlled trial examining the effects of a behaviour change guided lifestyle intervention on increasing adherence to the World Cancer Research Fund (WCRF) cancer prevention guidelines, compared to the wait-list usual care group, on diminishing cancer-related fatigue in colorectal cancer survivors.

Colorectal cancer survivors who completed treatment six months to five years ago and who suffer from cancer-related fatigue, are randomized into two parallel groups: an intervention group or the wait-list usual care group. The intervention group follows a six-month personalized lifestyle program, which is guided by behaviour change techniques, to increase adherence to the World Cancer Research Fund cancer prevention guidelines on healthy nutrition, physical activity and healthy weight. Participants are guided by a lifestyle coach specialized in behaviour change. The wait-list usual care group receives a lifestyle program after the intervention period of six months: this includes two personalized behavioural coaching sessions and any material that the intervention group also received.

Both groups participate in measurements at baseline, three months, at the end of the intervention (six months) and at follow-up (twelve months). The follow-up timepoint is included to study long-term behavioural lifestyle change. The primary outcome is the change in cancer-related fatigue, as measured by the FACIT-Fatigue questionnaire, between the intervention and wait-list usual care group from baseline till six months.

Secondary outcomes include cancer-related fatigue (at other timepoints), skeletal muscle fat infiltration and cross-sectional area, gut microbiota composition, health-related quality of life, physical performance, sleep quality and duration, depression and anxiety, behavioural determinants and adherence to the WCRF guidelines by assessing habitual dietary intake, physical activity level, height, weight, waist circumference and BMI. Other outcomes of interest include, blood pressure, chrono-nutrition, colorectal cancer related complaints, hemoglobin blood levels, self-reported weight (at three months) and cost-effectiveness evaluation. Moreover, the following data will be collected to characterize the population: sociodemographic information (age, sex, marital status, education, smoking) and clinical parameters (time since diagnosis, current and received treatment, comorbidities, medicine and supplement use).

Randomized controlled trial with two parallel arms: intervention and control.

The nature of the intervention does not allow for blinding of the participants or researchers. The baseline measurements are however blinded as both the participant and the researchers do not yet know in which group the participant will be classified. Randomization is done directly after the baseline measurements. After data collection, the database will be coded by an independent researcher to ensure that data analysis is conducted in a blinded way.

Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention

Blood pressure is measured using a sphygmomanometer. Both diastolic and systolic blood pressure are measured.

Heart rate is measured using a sphygmomanometer.

Chrono-nutrition, the timing of dietary intake, is measured with the "Chromes vragenlijst patiënten eetpatronen". This is a Dutch questionnaire containing 26 items that assess meal regularity (8-items), meal frequency (7-items), and meal clock time (11-items).

Measuring colorectal cancer specific problems is done using the additional concerns (i.e. subscale) of the Functional Assessment of Cancer Therapy - Colorectal (FACT-C). This questionnaire contains 9 items and scores are ranging from 0-28 points.

Finger prick blood sampling is used for assessing haemoglobin status as an indicator for anaemia.

Sociodemographic information is collected using standardized questionnaires.

Clinical parameters such as time since diagnosis, current and received treatment, comorbidities and medicine use, are collected either via standardized questionnaires or from medical records (part of informed consent).

Cancer-related fatigue is assessed with the FACIT-Fatigue Scale, a 13 item questionnaire with scores ranging from 0-52. A score below 34 indicates fatigue. The minimal clinically important difference is reported to be 3.0 for this scale.

Echo intensity of the skeletal muscle rectus femoris, lateral gastrocnemius and biceps brachialis is measured using a portable ultrasound machine.

Faecal samples are collected and the microbiota composition in this will be analyzed. The investigators will use 16S rRNA sequencing data for the taxonomic characterization of the gut microbiota. Eventually shotgun sequencing may also be done.

Health-related quality of life is measured with the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which contains the following domains of well-being: physical, social/family, emotional and functional. The 27-item questionnaire has scores ranging from 0 to 108.

This test indicates cardiovascular fitness by heart rate measurement for one minute after the completion of three minutes of stepping.

This test indicates lower extremity skeletal muscle strength. The time necessary to achieve the standing position on the 5th repetition is measured.

This test measures balance for three different standing positions. Each position has to be maintained for 10 seconds in order to pass the test.

This test measures lower extremity and lower back flexibility. Participants sit on a chair and bend forward and reach for their toes. The distance between the hand and toes is measured.

This test uses a hand dynamometer to measure strength.

Sleep quality is measured with the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire with scores ranging from 0-21. A score above 5 indicates bad sleep quality.

The Consensus sleep diary morning (CSD), a 15-item diary, is used for measuring other sleep outcomes such as sleep onset latency and sleep duration.

Depression is measured using the 8-item Patient Healthcare Questionnaire (PHQ-8). It contains 8 items, and scores range from 0-24, with higher scores indicating a higher chance of depression.

Anxiety is measured using the 7-item Generalized Anxiety Disorder (GAD-7). The GAD-7 contains 7 items, its scores range from 0-21, with higher scores indicating a higher chance of anxiety.

Identified behavioural determinants through focus groups and a systematic review, are assessed using a self-reported questionnaire with questions based on previous reported questions on different determinants. These were adapted to reflect the WCRF guidelines. Higher scores for each of the determinants (scale 1-7) indicate better results.

Nutritional intake is measured using a semi-quantitative Food Frequency Questionnaire (FFQ). Scores are calculated using the Dutch National Food Consumption tables. In addition, the validated questionnaire Eetscore is used, which contains a short online questionnaire (10-15 minutes) that serves as an indicator to assess diet quality, based on the Dutch Healthy Diet index 2015 (DHD15-index). Scores range from 0-160, with higher scores indicating better diet quality.

Nutritional intake is also measured using the validated questionnaire Eetscore, which uses a short online questionnaire (10-15 minutes) that serves as an indicator to assess diet quality, based on the Dutch Healthy Diet index 2015 (DHD15-index). Scores range from 0-160, with higher scores indicating better diet quality.

Physical activity is measured using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH). The questions in the SQUASH are pre-structured in commuting, leisure time, household and work/school activities. Scores will be assigned to the different reported activities base on intensities in MET and translated to minutes of physical activity.

Physical activity is also measured using ActivPalTM Micro3, an accelerometer measuring sedentary behaviour and physical activity. The ActivPalTM is worn for 9 days.

Height (in cm) is measured with a stadiometer.

Weight (in kg) is measured with a calibrated scale.

Waist circumference (in cm) is measured using tape measures.

The cost-effectiveness of the intervention is evaluated using a questionnaire that includes items on for example costs that the participant has made in order to follow the lifestyle program.

World Cancer Research Fund International

Gelderse Vallei Hospital

Flevoziekenhuis

Slingeland Hospital

Rijnstate Hospital

Het Prospectief Landelijk CRC cohort (PLCRC)

Deventer Ziekenhuis

Wageningen University

Dr.Ir.

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Xeroderma Pigmentosum

Ichthyosis

Congenital Abnormalities

Skin Abnormalities

Infant, Newborn, Diseases

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Skin Diseases, Genetic

Genetic Diseases, Inborn

Photosensitivity Disorders

Pigmentation Disorders

DNA Repair-Deficiency Disorders

Metabolic Diseases

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.

XPAND

Robert Sarkany, FRCP MD CCST

John Weinman, PhD, FbPsS

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.

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

1. 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

1. To compare the mean daily dose of UVR (SEDs) reaching the face between the intervention group and control group in August to September 2018 (follow-up 2)
2. To compare photoprotection practices between the intervention group and control group in June to July (follow-up 1)
3. To compare photoprotection practices between the intervention group and control group in August to September (follow-up 2)
4. To investigate with-in group changes in photoprotection practices pre and post the intervention up to 9 months follow-up
5. To compare between group differences in mean mood, habit formation, goal priority and self-efficacy for managing barriers between the intervention group and control group in June to July (follow-up 1)
6. To compare between group differences in mean mood, habit formation, goal priority and self-efficacy for managing barriers between the intervention group and control group in August to September (follow-up 2)
7. To investigate with-in group changes in quality of life, emotional wellbeing, habitual behaviour, self-efficacy, personalised psychosocial drivers, self-rated adherence pre and post the intervention up to 9 months follow-up
8. To qualitatively explore psychosocial "mechanisms of change" related to the intervention from the perspective of the participant
9. To qualitatively explore the acceptability and feasibility of the intervention from the perspective of the participant
10. To identify the health economic cost of the intervention

Design The study will test the efficacy of the intervention using a randomised controlled trial (RCT) design. It is a "delayed RCT", the intervention group will receive the intervention in year 1 (2018) and be compared to the control group. The control group will receive the intervention in 2019. It would not be possible to complete the intervention and measurement in both groups during the same season, when UVR levels are comparable. 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 of 21 days in 2018 (June to July; August to September) and two follow-up periods in 2019 (March, June to July) (delayed intervention group only). Psychosocial constructs and photoprotection practices will be assessed at baseline, at the start of each follow-up period (self-report questionnaires) and during these follow-up periods (daily measures on the UVR protection diary). 9 months after baseline (December 2018, 2019) self-report questionnaires will be completed. A process and acceptability evaluation will be conducted using qualitative interviews. A health economic evaluation of the intervention will be assessed by completion of questionnaires to assess health-related quality of life and service use in December 2018, 2019. The study is a main trial. There is no pilot or feasibility study due to the small population from which the sample will be obtained (adults with XP in UK without cognitive impairment).

Procedure Eligible patients will be identified from the patient list, XP Service at Guy's and St Thomas' NHS Foundation Trust and sent an invitation letter. The investigators will send out the information sheet and request that the patient contact the research team if they wish to participate. This will be followed up with a phone call answer any questions they might have and see if they wish to participate. Those wishing to take part will be visited by a member of the research team to complete the consent process and deliver study materials. Participants will complete the baseline assessment which involves wearing a UVR monitor called a dosimeter, completing a UVR protection diary for a 3 week period (March-April 2018) and questionnaires. The dosimeter is then worn continuously during the day March to September 2018. Participants are then randomised to receive the intervention in 2018 or 2019. Participants receiving the intervention in 2018, will then take part in the first 6 sessions of the intervention across 12 weeks. All participants then repeat the baseline measurement protocol. The intervention group will then receive a booster intervention session and both groups will complete a second follow-up assessment period. Intervention participants will then take part in a qualitative interview. At 9-months post baseline all participants will complete self-report questionnaires. If a participant is randomised to receive the intervention in 2019, they will repeat the procedure excluding the second follow-up assessment period and will wear the dosimeter from March to July 2019.

Data management To protect the anonymity of the participants, once consent has been given, participants will be given a unique identifier. Data recorded on paper will be stored at the XP research office at King's College London., in locked cabinets in a locked room. Data entered electronically will be stored in password protected files accessible via a drive only accessible to the XP Research Team.

Progress will be monitored by the Trial Steering Committee, Independent Steering Committee and our funder NIHR.

Sample size The target sample size is 24 accounting for potential attrition of 20%. Based on the primary outcome being the between group difference in mean daily UVR dose to the face across a period of 21 days in June to July, the target sample size of 20 individuals (excluding dropouts) leads to a total of 210 daily observations for the 10 participants randomised to each arm. In previous research, the mean daily UVR dose to the face was .27 SED (SD=.14) with a within-person correlation of ICC=.31. Adjusting for the design effect due to the dependence of assessments within individuals, and accepting a liberal 10% alpha and 20% beta level due to the rare nature of the condition, this sample size would have 80% power to detect a reduction of .10 SED in mean UVR dose to the face. In terms of standardised mean difference this relates to an effect size of d=.73, which is considered to be a large effect. Given the tailored nature and expected intensity of the intervention, expecting such a difference does not seem unreasonable though it must be accepted that power would not be sufficient to detect smaller but still clinically meaningful differences. Where the target dose to the face is 0 SED, a reduction of .1 SED relates to around a 30% overall reduction in UVR dose to the face. To allow for an estimated attrition rate of 20% the target total sample size is 24.

Analysis for primary objective The treatment effect on the primary outcome of daily UVR dose to the face during over 21 days between June and July and secondary outcome of daily UVR dose to the face during over 21 days between August and September will be estimated using generalised linear mixed models. Given the skewed distribution of UVR dose to face a logarithmic transformation will be applied. A random intercept will account for the repeated assessments of UVR dose to the face within individuals across 42 days. Group will be entered as an indicator variable along with a time period indicator (i.e. early vs late summer), any stratification factors used in the randomisation (e.g. complementation type) and baseline mean daily UVR dose to face. Two baseline levels of mean daily UVR dose to face will be included in the analysis as covariates; mean daily UVR dose to face collected in previous study (21 days between June and July 2016) and pre-intervention mean daily UVR dose to face ( 21 days between March and April 2018). Given the rare nature of the condition, the investigators will accept a higher than usual false positive rate and will accept the treatment is efficacious where the p-value for the group coefficient is p\<.1 (i.e. 10% critical alpha level). The analysis will follow the intention to treat principle with individuals analysed within the groups to which they were randomised irrespective of whether they received or persisted with the intervention. Sensitivity analysis will consider treatment effects in a per-protocol analysis of those completing the intervention.

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.

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.

XPAND Trial: Enhancing XP Photoprotection Activities - New Directions

The XPAND Evaluation of a Personalised Adherence Intervention to Improve Photoprotection Behaviour in Adults With Xeroderma Pigmentosum (XP): Randomised Controlled Trial.

There is no plan to make participant data available to other researchers.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

King's College London

Newcastle University

University of Cambridge

Guy's and St Thomas' NHS Foundation Trust

Gland and Hormone Related Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 2

Anxiety Disorders

Depressive Disorder

Syndrome

Depression

Obesity

Metabolic Syndrome

Insulin Resistance

Hyperinsulinism

Glucose Metabolism Disorders

Endocrine System Diseases

A physical activity referral scheme co-developed by multidisciplinary stakeholders to incorporate behaviour change support and ensure pragmatic relevance and feasibility.

Comparative, usual care exercise referral scheme.

Lifestyle advice leaflet only (provided to participants in all arms during baseline assessments).

An 18-week physical activity referral scheme co-developed by a local multidisciplinary stakeholder group. Behaviour change support underpinned by Self-Determination Theory (Ryan \& Deci, 2000) will be provided by an exercise referral practitioner at weeks 1,4,8,12 and 18 to facilitate increased physical activity levels. Patients will be supported to develop a tailored programme of physical activity that may involve use of the fitness centre facilities (e.g. swimming, group classes, gymnasium use), participation in community-based initiatives, and changes to habitual physical activity. Focus on promoting patient autonomy and tailoring activities to patient's preferences and needs. Subsidised access to fitness centre facilities for first 12 weeks.

Physical activity referral scheme

A comparative usual care exercise referral scheme that includes fitness centre based activities (e.g. swimming, group classes, gymnasium use). Patients meet an exercise referral practitioner at their induction (week 1) and week 12 (post scheme). Patients are typically prescribed a gym-based, 12-week programme. Subsidised access to fitness centre facilities for 12 weeks.

Usual care exercise referral scheme

Paula M Watson, PhD

The study will evaluate the effectiveness of a co-developed exercise referral scheme. Participants will be recruited to one of three groups 1. Co-developed exercise referral scheme, 2. Usual care exercise referral scheme, 3. No treatment control (no intervention). The study will measure effectiveness by observing change in cardiorespiratory fitness at 12 weeks. Intervention cost-effectiveness will also be evaluated at 3 months follow-up using objective physical activity data.

Evidence of effectiveness for UK exercise referral is unclear. This representation has been deemed an unfair assessment of its potential to impact public health. This is due to systematic review evidence that reports evaluations of exercise referral interventions that are not evidence-based or underpinned by behaviour change theory.

This evaluation is the third phase of a project that aims to co-develop (Phase 1), pilot (phase 2) and evaluate (phase 3) an evidence-based exercise referral scheme. This approach is underpinned by the Medical Research Council guidance for complex interventions.

Through co-development work with a multidisciplinary group of researchers and local stakeholders and subsequent pilot work, it is hypothesised that the co-developed, evidence-based intervention will have improved chances of implementation success, and therefore, clinical effectiveness.

3 arm quasi-experimental trial

1. Co-developed scheme 2. Usual care 3. No treatment control

Post hoc data analysis will be blinded via an independent coding method for condition and time frame (i.e. pre-post measures).

Evaluation of a Physical Activity Referral Scheme

Clinical and Cost-effectiveness of a Co-developed, Evidence-based Physical Activity Referral Scheme for the Treatment and Prevention of Health Conditions: a Pragmatic Trial

The Behavioural Regulation in Exercise Questionnaire (BREQ-2, Markland \& Tobin, 2004) plus 4 additional items (Wilson et al., 2006a) will be used to assess exercise motivation. The BREQ-2 is a widely-used instrument comprised of 19 items describing reasons why people exercise (e.g. "I think exercising is a waste of time"; "I feel ashamed when I miss an exercise session"; "I exercise because it's fun"). Participants answer on a likert scale of 0 (not true for me) to 4 (very true to me) to indicate how true each item is for them.

Psychological need satisfaction will be measured using the Psychological Need Satisfaction in Exercise Scale (PNSE, Wilson et al., 2006b). The PNSE is an 18-item instrument designed to measure participants' perceived autonomy (e.g. "I feel free to exercise in my own way"), competence (e.g. "I feel capable of completing exercises that are challenging to me") and relatedness (e.g. "I feel connected to the people who I interact with while we exercise together") in an exercise context. Participants are asked to answer on a 6-point likert scale (1 = false, 6 = true) to indicate how they typically feel when they exercise.

Needs support will be measured using a 15-item needs support (NS) tool developed by Markland and Tobin (2010) to measure the extent to which participants perceive their exercise instructors provide support for autonomy, structure (linked to competence) and involvement (linked to relatedness).

Three items developed by Edmunds et al. (2007) will be used to assess patients' intentions to engage in PA (e.g. "I plan to regularly engage in PA during the next 3 months").

Focus groups will be conducted with a purposeful subsample of patients after approximately 6-12 weeks of attending the scheme (e.g. those with low attendance, high attendance, significant health changes, no change etc.). Two focus groups will be conducted with patients attending the intervention centre (approx 5-8 participants per group). Focus groups will be conducted at the individual fitness centres and will last approximately 60 minutes. Discussion will focus on the extent to which, and how, patients feel each ERS is facilitative (or not) in helping them become more physically active, with questions about staff interactions, activities on offer, and the impact of the scheme on their likely continuation with physical activity.

Focus groups will be conducted with a purposeful subsample of patients after approximately 6-12 weeks of attending the scheme (e.g. those with low attendance, high attendance, significant health changes, no change etc.). Two focus groups will be conducted with patients attending the usual care centre (approx 5-8 participants per group). Focus groups will be conducted at the individual fitness centres and will last approximately 60 minutes. Discussion will focus on the extent to which, and how, patients feel each ERS is facilitative (or not) in helping them become more physically active, with questions about staff interactions, activities on offer, and the impact of the scheme on their likely continuation with physical activity.

ERPs from the intervention centre only will take part in a semi-structured interview (after over half of patients have reached the 18-week point). The interviews will aim to explore the acceptability of the co-developed intervention, any challenges of delivery, and areas that require further development etc.

Estimated via the Astrand-Rhyming cycle protocol using the updated age and sex specific nomogram.

Objective physical activity levels will be analysed using a hip worn accelerometer (ActiGraph GT3X). 7-day monitoring periods will recorded at three time points. During the 7-day monitoring period, each participant will complete a diary to record hours of use and to distinguish between work and leisure hours.

Endothelium dependent vasodilatation of the brachial arteries will be examined using ultrasound. Brachial artery baseline diameter and blood flow will be assessed in one arm. An ultrasound probe is placed on the bicep for 1 minute before a blood pressure cuff (placed around the forearm) is inflated to suprasystolic pressure (\~220 mmHg) for 5 minutes. Immediately after the cuff is deflated, changes in arterial diameter and flow will be assessed continuously for 3 minutes using the ultrasound probe. Ultrasound data will then be analysed post hoc.

The carotid vasoreactivity (cold pressor) test will measure the carotid artery's response to a stimulus. Similar to the flow-mediated dilation procedure, an ultrasound probe will be placed on the patient's left side of their neck, positioned in such a way to allow a clear image of the right common carotid artery to be displayed on the ultrasound monitor screen. The cold pressor procedure involves submersion of the left hand to wrist in ice slush for 180-seconds. Ultrasound data will then be analysed post hoc.

A 15ml blood sample will be taken. Blood profiles will be analysed as a measure of cardiometabolic health. Analysis will be conducted at LJMU. Patients will be made aware of the storage and use of their tissue.

Patients' perceived physical activity levels will be recorded with the short version of the International Physical Activity Questionnaire (IPAQ, Craig et al., 2003). The short-IPAQ is a 7-day recall self-administered tool that measures intensity, frequency and duration of physical activity and provides a total estimate of energy expenditure. A total score of MET-minutes/day/week and sedentary behaviour minutes/day/week will be calculated according to the IPAQ scoring protocol.

Psychological wellbeing will be measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS, Tennant et al., 2007). WEMWBS is a 14-item positively worded instrument containing items related to psychological functioning (e.g. "I've been thinking clearly") and subjective well-being (e.g. "I've been feeling cheerful"). Participants are asked to rate on a Likert scale of 1 (none of the time) to 5 (all of the time) how well each statement describes their experiences over the last two weeks.

Patient attendance records will be collected by ERPs at the following time-points:

* Intervention centre: 1, 4,8,12 and 18 weeks;
* Usual care centre: 1 and 12 weeks.

The number of times patients sign in at the fitness centre to go to either the gym or a class will be recorded on a weekly basis for weeks 1 to 12, then on a monthly basis up to 6 months. This information is automatically recorded at fitness centres when patients visit.

ERPs from both intervention and usual care centres will be asked to monitor the number of consultations offered (measured by appointment bookings or records of appointments offered but declined by participants), and the number of consultations conducted for each patient.

A random sample of ERS inductions from both intervention and usual care centres (approx 10 per centre) plus a random sample of 4, 8, 12 and 18-week consultations from the intervention centre only will be audio-recorded and coded for the use of "needs-supportive" communication strategies (using a coding manual developed through a previous pilot study (REF 16/WA/0231)). In addition, all intervention centre recordings will be coded for fidelity to an agreed protocol, e.g. asking required questions about physical activity, setting an action plan, giving out patient log book etc.

Participants' change in health-related quality of life (HRQoL) will be measured at baseline, 12 weeks, and 6 months. The EQ-5D will be used, this is a validated tool for measuring HRQoL. This tool has been applied successfully in a recent UK trial-based economic evaluation of exercise referral schemes (Edwards et al. 2013).

Captured via telephone interview with Exercise Referral Scheme Personnel from (organisation e.g. local authority/ fitness centre/ research institute; questions adapted from validated questionnaire).

Captured via telephone interview with fitness centre manager and/or coordinators (questions have been used in previous research).

Captured via patient questionnaire during lab testing (questions adapted from validated questionnaire).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania	NCT02680613	Cervical Cancer	Motivational SM... Travel Voucher	25 Years - 49 Years	Queen's University
Targeted Vs Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors	NCT05450315	Behaviour Chang...	Stride to Survi... Canadian Physic...	18 Years - 39 Years	University of Alberta
Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention	NCT05390398	Colorectal Canc... Cancer-related ... Colon Cancer Rectal Cancer	Behaviour chang...	18 Years -	Wageningen University
XPAND Trial: Enhancing XP Photoprotection Activities - New Directions	NCT03445052	Xeroderma Pigme...	XPAND	16 Years -	Guy's and St Thomas' NHS Foundation Trust
Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention	NCT05390398	Colorectal Canc... Cancer-related ... Colon Cancer Rectal Cancer	Behaviour chang...	18 Years -	Wageningen University
Pilot Study of a Mobile Health Approach to Reduce Barriers to Cervical Cancer Screening in Tanzania	NCT02680613	Cervical Cancer	Motivational SM... Travel Voucher	25 Years - 49 Years	Queen's University
Evaluation of a Physical Activity Referral Scheme	NCT03490747	Cardiovascular ... Diabetes Mellit... Anxiety Depression Musculoskeletal... Cardiovascular ... Cancer Obesity Metabolic Syndr... Physical Activi...	Physical activi... Usual care exer...	18 Years -	Liverpool John Moores University

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