Personalised Behavioural Intervention in Cancer Screening Programmes (CANVIA)
Feasibility, Acceptability and Preliminary Efficacy of a Personalised Behavioural Intervention to Improve Adherence to Dietary and Lifestyle Cancer Prevention Recommendations in Adults Attending Breast and Colorectal Cancer Screening Programmes: A Three-Arm Randomised Pilot Trial (CANVIA)
The aim of this clinical trial is to find out whether CANVIA can help adults improve dietary and lifestyle habits related to cancer prevention. CANVIA is a personalised programme based on cancer prevention recommendations from the World Cancer Research Fund and the American Institute for Cancer Research (WCRF/AICR). The programme uses a short questionnaire, called the WCRF/AICR Screener, to give each participant personalised feedback.
This study will include adults aged 50 to 69 years who take part in breast or colorectal cancer screening programmes in Palma, Mallorca, Spain. The study will assess whether participants can complete the CANVIA study procedures and use the programme for six months, whether the CANVIA app and, where applicable, the professional support are acceptable and easy to use, and whether there are early signs that CANVIA may help participants follow cancer prevention recommendations more closely.
Before the pilot trial starts, a small first phase with about 20 to 30 participants will test the study procedures and the mobile app. After this, 132 participants will be assigned by chance to one of three groups. One group will receive only a personalised written report at the start of the study. A second group will use the CANVIA mobile app for six months. A third group will use the CANVIA mobile app and also receive support from health professionals for six months.
Participants will complete study assessments at the start of the study, after three months and after six months. Participants in the app groups will receive personalised messages, educational resources and weekly goals or challenges. Some participants from the app groups will also be invited to take part in focus groups at the end of the study to share their experiences and suggestions.
Přehled studie
Postavení
Detailní popis
CANVIA is a personalised behavioural intervention designed to support adherence to dietary and lifestyle recommendations for cancer prevention. The intervention is based on the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Cancer Prevention Recommendations and uses the WCRF/AICR Screener to assess individual adherence, generate personalised feedback, and tailor intervention intensity and content.
This study corresponds to the prospective feasibility evaluation of CANVIA. It will be conducted within population-based breast and colorectal cancer screening programmes in Palma, Mallorca, Spain, among adults aged 50 to 69 years. The purpose of the study is to evaluate whether CANVIA is feasible, usable, acceptable and engaging in this public health setting, and to explore its preliminary efficacy for improving adherence to WCRF/AICR cancer prevention recommendations.
The study will be conducted in two sequential quantitative phases, followed by an embedded qualitative component. First, a single-arm proof-of-concept phase will include approximately 20 to 30 participants. This phase will assess the operational readiness of the recruitment pathway, study procedures, data collection system, mobile application and intervention delivery. Findings from this phase will be used to refine study procedures and digital tools before initiating the randomised pilot feasibility trial.
The subsequent pilot trial will use a three-arm, parallel-group, randomised design with an anticipated enrolment of 132 participants. Participants will be randomly assigned in a 1:1:1 ratio to one of three groups: a control group receiving a personalised baseline feedback report, a mobile app-based CANVIA intervention, or the same mobile app-based intervention combined with structured support from health professionals.
In the active intervention groups, the WCRF/AICR Screener score will be used to classify participants according to their need for lifestyle change and to tailor the intensity and target behaviours of the intervention. The mobile app-based intervention will include tailored messages, educational resources and app-based goals or challenges. Participants receiving additional professional support will also have structured contacts focused on reviewing personalised recommendations, supporting goal setting, monitoring progress, providing feedback and addressing barriers to change.
The intervention will last six months and will be organised into two three-month blocks. The WCRF/AICR Screener will be repeated at Month 3 to monitor changes in adherence and, where appropriate, to update intervention intensity and target behaviours for the second intervention block. Study assessments will be conducted at baseline, Month 3 and Month 6.
The planned pilot trial sample size is 132 participants, with 44 participants per arm. This sample size allows for up to 30% loss to follow-up and is intended to support the assessment of feasibility outcomes and exploratory between-group comparisons in WCRF/AICR Screener score at Month 6.
Main evaluation domains will include feasibility, usability, acceptability, app engagement and preliminary efficacy. Analyses of the pilot trial will follow the intention-to-treat principle. Preliminary efficacy in improving adherence to cancer prevention recommendations will be explored using a linear mixed model including study arm, time, and the arm-by-time interaction; planned pairwise comparisons at Month 6 will be reported with 95% confidence intervals.
Focus groups conducted at Month 6 with participants from the intervention groups will explore participant experiences, barriers and facilitators to engagement, and suggestions for improving the intervention and study procedures before future larger-scale evaluation. Qualitative data from focus groups will be analysed thematically.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dora Romaguera Bosch, PhD
- Telefonní číslo: 64517 +34871205000
- E-mail: mariaadoracion.romaguera@idisba.es
Studijní záloha kontaktů
- Jméno: León González Casas, Máster
- Telefonní číslo: +34673829884
- E-mail: octavioleon.gonzalez@idisba.es
Studijní místa
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Španělsko, 07120
- Fundació Institut d'Investigació Sanitària Illes Balears
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Women and men participating in the breast and/or colorectal cancer screening programmes within the Sector Sanitari Ponent, Hospital Universitari Son Espases.
- Aged 50 to 69 years.
- No history of cancer.
- No evidence of an active tumour process, defined as a negative screening result and/or negative complementary tests, as applicable.
- Able and willing to provide written informed consent prior to any study procedure.
- Sufficient verbal and reading comprehension of Spanish and/or Catalan to complete study procedures and questionnaires.
- Access to a smartphone with internet connection and sufficient storage, and ability to install and use the study application.
- Availability to attend the IdISBa Clinical Trials Unit at Hospital Universitari Son Espases for scheduled in-person visits, as agreed with the research team.
Exclusion Criteria:
- Any diagnosed condition that severely affects dietary intake or requires medically prescribed restrictive nutrition, such as an eating disorder, severe renal or gastrointestinal disease, or parenteral nutrition.
- Any diagnosed condition that severely limits the ability to perform light or moderate physical activity.
- Excessive alcohol consumption, defined as more than 6 standard units per day, or problematic substance use.
- Concurrent participation in another clinical trial that, in the investigator's judgement, may interfere with the present study outcomes.
- Body mass index <18.5 kg/m² or >40 kg/m²
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Control group
Participants allocated to the control group will complete the scheduled study assessments through the study data-collection system and will receive the personalised baseline feedback report based on their WCRF/AICR Screener responses.
They will not have access to the active intervention module of the mobile application and will not receive tailored messages, weekly challenges, or structured health professional support during the 6-month intervention period.
Participants in the control group will be offered post-trial access to the intervention if it is shown to be beneficial and where feasible.
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The personalised baseline feedback report consists of an individualised report provided at baseline, based on each participant's WCRF/AICR Screener responses.
The report provides feedback on adherence to cancer prevention recommendations.
In the control group, it is delivered as paper-based personalised recommendations and is the only active behavioural component delivered during the 6-month intervention period.
In the active intervention arms, the corresponding baseline feedback is delivered through the mobile application.
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Experimentální: Intervention A: mobile app intervention
Participants allocated to Intervention A will receive the personalised baseline feedback report and access to the active intervention module of the mobile application.
This module will include tailored messages, educational resources, infographics, recipes, physical-activity resources, alcohol-related resources, general cancer-prevention information, and a weekly goal/challenge component.
The intervention will be delivered over a 6-month period, with reassessment of the WCRF/AICR Screener at Month 3 to update tailoring where appropriate.
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The personalised baseline feedback report consists of an individualised report provided at baseline, based on each participant's WCRF/AICR Screener responses.
The report provides feedback on adherence to cancer prevention recommendations.
In the control group, it is delivered as paper-based personalised recommendations and is the only active behavioural component delivered during the 6-month intervention period.
In the active intervention arms, the corresponding baseline feedback is delivered through the mobile application.
The CANVIA mobile app intervention consists of access to the active intervention module of the mobile application.
The module includes tailored messages, educational resources, infographics, recipes, physical-activity resources, alcohol-related resources, general cancer-prevention information, and a weekly goal/challenge component.
Delivery is organised over a 6-month period.
Intervention intensity and target behaviours are tailored according to the WCRF/AICR Screener-based category and may be updated after the Month 3 reassessment.
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Experimentální: Intervention B: mobile app intervention plus professional support
Participants allocated to Intervention B will receive all components of Intervention A, combined with structured support from health professionals.
Health professionals involved in Intervention B will receive training and a delivery guide covering intervention aims, Screener-based tailoring procedures, core behaviour-change conversation skills, and documentation of professional contacts.
The intervention and professional support contacts will be delivered over a 6-month period, with reassessment of the WCRF/AICR Screener at Month 3. Contacts will focus on reviewing personalised recommendations, supporting goal setting, monitoring progress, providing tailored feedback, identifying barriers and facilitators, reinforcing implemented changes, and adapting strategies where needed.
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The personalised baseline feedback report consists of an individualised report provided at baseline, based on each participant's WCRF/AICR Screener responses.
The report provides feedback on adherence to cancer prevention recommendations.
In the control group, it is delivered as paper-based personalised recommendations and is the only active behavioural component delivered during the 6-month intervention period.
In the active intervention arms, the corresponding baseline feedback is delivered through the mobile application.
The CANVIA mobile app intervention consists of access to the active intervention module of the mobile application.
The module includes tailored messages, educational resources, infographics, recipes, physical-activity resources, alcohol-related resources, general cancer-prevention information, and a weekly goal/challenge component.
Delivery is organised over a 6-month period.
Intervention intensity and target behaviours are tailored according to the WCRF/AICR Screener-based category and may be updated after the Month 3 reassessment.
Additional health professional support consists of structured contacts delivered in addition to the CANVIA mobile app intervention.
Health professionals will receive training and a delivery guide to support standardised delivery and intervention fidelity.
Support is tailored according to the WCRF/AICR Screener-based category and may be updated after the Month 3 reassessment.
Contacts focus on reviewing personalised recommendations, supporting goal setting, monitoring progress, providing tailored feedback, identifying barriers and facilitators, reinforcing implemented changes, and adapting strategies where needed.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Proportion of invited individuals enrolled and randomised
Časové okno: From invitation to baseline randomisation in the randomised pilot trial
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Recruitment feasibility in the randomised pilot trial will be assessed as the number of invited individuals who are enrolled and randomised divided by the total number of invited individuals.
Reasons for non-participation and ineligibility will be recorded when available.
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From invitation to baseline randomisation in the randomised pilot trial
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Proportion of randomised participants retained at Month 3 and Month 6
Časové okno: Month 3 and Month 6
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Retention will be assessed as the number of randomised participants who complete follow-up assessments at Month 3 and Month 6 divided by the total number of randomised participants.
Reasons for withdrawal or loss to follow-up will be summarised when available.
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Month 3 and Month 6
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Proportion of expected outcome and covariate data completed
Časové okno: Baseline, Month 3 and Month 6
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Data completeness will be assessed as the number of completed expected outcome and covariate data fields divided by the total number of expected outcome and covariate data fields at each scheduled assessment time point.
This will include completion of the WCRF/AICR Screener and the study questionnaire battery
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Baseline, Month 3 and Month 6
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Proportion of scheduled study visits attended
Časové okno: Baseline, Month 3 and Month 6
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Attendance at study visits will be assessed as the number of scheduled data-collection visits attended divided by the total number of scheduled data-collection visits.
This measure will be assessed across all study arms.
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Baseline, Month 3 and Month 6
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Proportion of planned health professional support contacts attended
Časové okno: From baseline to Month 6
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Attendance at professional support contacts will be assessed in Intervention B as the number of planned health professional support contacts attended divided by the total number of planned health professional support contacts.
Contacts may be planned according to the participant's WCRF/AICR Screener-based category.
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From baseline to Month 6
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Number of technical incidents requiring study staff support
Časové okno: From baseline to Month 6
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Operational and technical feasibility will be assessed as the number of technical incidents requiring support from study staff during the intervention period.
Technical incidents may include problems related to access to digital study tools, use of the CANVIA mobile application, completion of digital assessments, or other technical issues affecting intervention delivery or data collection.
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From baseline to Month 6
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Mean overall score on the mHealth App Usability Questionnaire at Month 6
Časové okno: Month 6
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App usability will be assessed in the app-based intervention arms using the Spanish culturally adapted version of the mHealth App Usability Questionnaire, standalone patient version.
Items are rated on a 7-point Likert scale, with higher scores indicating better perceived usability.
The outcome will be summarised as the mean overall usability score at Month 6.
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Month 6
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Mean item scores on the adapted Research Participant Perception Survey-Long Form at Month 6
Časové okno: Month 6
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Acceptability and participant perception will be assessed using an adapted Spanish version of the Research Participant Perception Survey-Long Form.
Responses will be summarised as mean item scores for pre-specified items assessing participants' perception of the intervention and study procedures.
Higher or more favourable scores will indicate better perceived acceptability and participant experience.
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Month 6
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Number of CANVIA mobile app logins or sessions per participant through Month 6
Časové okno: From baseline to Month 6
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App engagement will be assessed in the app-based intervention arms using automatically captured usage data.
This outcome will be summarised as the number of CANVIA mobile app logins or sessions per participant during the 6-month intervention period.
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From baseline to Month 6
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Number of active days in the CANVIA mobile app per participant through Month 6
Časové okno: From baseline to Month 6
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App engagement will be assessed in the app-based intervention arms using automatically captured usage data.
This outcome will be summarised as the number of days on which each participant actively used the CANVIA mobile app during the 6-month intervention period.
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From baseline to Month 6
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Proportion of expected key in-app actions completed through Month 6
Časové okno: From baseline to Month 6
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App engagement will be assessed in the app-based intervention arms using automatically captured usage data.
This outcome will be calculated as the number of completed key in-app actions divided by the number of expected or pre-specified key in-app actions during the 6-month intervention period.
Key in-app actions may include opening tailored content, accessing resources, responding to weekly challenges, or completing other pre-specified intervention-related actions.
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From baseline to Month 6
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean change in WCRF/AICR Screener score from baseline to Month 6
Časové okno: Baseline and Month 6
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Preliminary efficacy will be assessed as the mean change in adherence to cancer prevention recommendations, measured using the WCRF/AICR Screener score.
The total score ranges from 0 to 7 in this study, with higher scores indicating greater adherence to the WCRF/AICR Cancer Prevention Recommendations.
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Baseline and Month 6
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Themes describing participant experiences from Month 6 focus groups
Časové okno: Month 6
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Participant experiences will be explored through focus groups with participants from the intervention arms.
Focus groups will examine perceived acceptability and appropriateness of the intervention, barriers and facilitators to engagement and participation, and suggestions for improving the intervention and study procedures.
Data will be analysed thematically.
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Month 6
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Dora Romaguera Bosch, PhD, CIBER (Consorcio de Investigación Biomédica en Red); IdISBa (Fundació Institut d'Investigació Sanitària Illes Balears)
- Vrchní vyšetřovatel: Guillem Artigues Vives, PhD, Conselleria de Salut, Govern de les Illes Balears
Publikace a užitečné odkazy
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Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- PI24/01647
- IB 6026/26 PI (Jiný identifikátor: Medicinal Products Research Ethics Committee of the Balearic Islands (CEIm-IB))
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
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