Dietary and Lifestyle Behaviour ChangeCANVIANCT07722442
Personalised Behavioural Intervention in Cancer Screening Programmes
A study testing Personalised baseline feedback report, CANVIA mobile app intervention and Additional health professional support in people with Dietary and Lifestyle Behaviour Change, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary and Lifestyle Behaviour Change
- What is being tested?
- Personalised baseline feedback report, CANVIA mobile app intervention and Additional health professional support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Fundació Institut d'Investigació Sanitària Illes Balears
Palma de Mallorca, Balearic Islands, 07120
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Dietary and Lifestyle Behaviour Change
- Being tested
- Personalised baseline feedback report, CANVIA mobile app intervention, Additional health professional support
- Keywords
- Cancer prevention recommendations, Behavioural intervention, Lifestyle intervention, Mobile health, Feasibility studies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised baseline feedback reportBehavioural
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.
CANVIA mobile app interventionBehavioural
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 supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Behavioral: Personalised baseline feedback report |
| Intervention A: mobile app intervention | Experimental | 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. Receives: Behavioral: Personalised baseline feedback report; Behavioral: CANVIA mobile app intervention |
| Intervention B: mobile app intervention plus professional support | Experimental | 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. Receives: Behavioral: Personalised baseline feedback report; Behavioral: CANVIA mobile app intervention; Behavioral: Additional health professional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of invited individuals enrolled and randomised
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.
Measured: From invitation to baseline randomisation in the randomised pilot trial
Proportion of randomised participants retained at Month 3 and Month 6
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.
Measured: Month 3 and Month 6
Proportion of expected outcome and covariate data completed
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
Measured: Baseline, Month 3 and Month 6
Proportion of scheduled study visits attended
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.
Measured: Baseline, Month 3 and Month 6
Proportion of planned health professional support contacts attended
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.
Measured: From baseline to Month 6
Number of technical incidents requiring study staff support
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.
Measured: From baseline to Month 6
Mean overall score on the mHealth App Usability Questionnaire at Month 6
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.
Measured: Month 6
Mean item scores on the adapted Research Participant Perception Survey-Long Form at Month 6
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.
Measured: Month 6
Number of CANVIA mobile app logins or sessions per participant through Month 6
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.
Measured: From baseline to Month 6
Number of active days in the CANVIA mobile app per participant through Month 6
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.
Measured: From baseline to Month 6
Proportion of expected key in-app actions completed through Month 6
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.
Measured: From baseline to Month 6
Secondary outcomes (1)
Mean change in WCRF/AICR Screener score from baseline to Month 6
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.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Dietary and Lifestyle Behaviour ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study includes an initial single-arm proof-of-concept phase to assess operational readiness and refine study procedures before the pilot trial. Approximately 30 participants are enrolled in this single-arm phase. The subsequent pilot trial uses a three-arm, parallel-group, randomised design with 132 participants. Pilot trial participants will be allocated in a 1:1:1 ratio to a control group receiving personalised baseline feedback, a mobile app-based CANVIA intervention, or the same mobile app-based intervention combined with health professional support.
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III, Conselleria de Salut, Govern de les Illes Balears, Consorcio Centro de Investigación Biomédica en Red (CIBER), University of the Balearic Islands
- Responsible party
- Sponsor
- Investigators
- Dora Romaguera Bosch, PhD, Principal investigator, CIBER (Consorcio de Investigación Biomédica en Red); IdISBa (Fundació Institut d'Investigació Sanitària Illes Balears)Guillem Artigues Vives, PhD, Principal investigator, Conselleria de Salut, Govern de les Illes Balears
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722442
- Sponsor's protocol ID
- PI24/01647
- Other IDs
- IB 6026/26 PI
- Acronym
- CANVIA
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
Schwarzer R, Baessler J. Evaluación de la autoeficacia: adaptación española de la Escala de Autoeficacia General. Ansiedad y Estrés. 1996;2(1):1-8.
Schwarzer R, Jerusalem M. Generalized Self-Efficacy Scale. In: Weinman J, Wright S, Johnston M, editors. Measures in Health Psychology: A User's Portfolio. Causal and Control Beliefs. Windsor: NFER-NELSON; 1995. p. 35-37.
American Institute for Cancer Research, World Cancer Research Fund. Diet, Nutrition, Physical Activity and Cancer: a Global Perspective. A Summary of the Third Expert Report. 2018.
Solans M, Chan DSM, Mitrou P, Norat T, Romaguera D. A systematic review and meta-analysis of the 2007 WCRF/AICR score in relation to cancer-related health outcomes. Ann Oncol. 2020 Mar;31(3):352-368. doi: 10.1016/j.annonc.2020.01.001. Epub 2020 Jan 8.
PubMed 32067678Lucas-Carrasco R. The WHO quality of life (WHOQOL) questionnaire: Spanish development and validation studies. Qual Life Res. 2012 Feb;21(1):161-5. doi: 10.1007/s11136-011-9926-3. Epub 2011 May 25.
PubMed 21611868Mellor K, Eddy S, Peckham N, Bond CM, Campbell MJ, Lancaster GA, Thabane L, Eldridge SM, Dutton SJ, Hopewell S. Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting. BMJ Open. 2021 Jun 28;11(6):e048178. doi: 10.1136/bmjopen-2020-048178.
PubMed 34183348de la Fuente-Arrillaga C, Ruiz ZV, Bes-Rastrollo M, Sampson L, Martinez-Gonzalez MA. Reproducibility of an FFQ validated in Spain. Public Health Nutr. 2010 Sep;13(9):1364-72. doi: 10.1017/S1368980009993065. Epub 2010 Jan 28.
PubMed 20105389Rodriguez-Munoz S, Corella C, Abarca-Sos A, Zaragoza J. Validation of three short physical activity questionnaires with accelerometers among university students in Spain. J Sports Med Phys Fitness. 2017 Dec;57(12):1660-1668. doi: 10.23736/S0022-4707.17.06665-8. Epub 2017 Mar 1.
PubMed 28249383Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Kost RG, de Rosa JC. Impact of survey length and compensation on validity, reliability, and sample characteristics for Ultrashort-, Short-, and Long-Research Participant Perception Surveys. J Clin Transl Sci. 2018 Feb;2(1):31-37. doi: 10.1017/cts.2018.18. Epub 2018 Jul 6.
PubMed 30393572Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.
PubMed 30973342Avery KN, Williamson PR, Gamble C, O'Connell Francischetto E, Metcalfe C, Davidson P, Williams H, Blazeby JM; members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open. 2017 Feb 17;7(2):e013537. doi: 10.1136/bmjopen-2016-013537.
PubMed 28213598Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
PubMed 27777223Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
PubMed 34593508
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07722442
- Acronym / sponsor ID
- CANVIA / PI24/01647
- Conditions
- Dietary and Lifestyle Behaviour Change
- Keywords
- Cancer prevention recommendations, Behavioural intervention, Lifestyle intervention, Mobile health, Feasibility studies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes BalearsOther government
- Collaborators
- Instituto de Salud Carlos III, Conselleria de Salut, Govern de les Illes Balears, Consorcio Centro de Investigación Biomédica en Red (CIBER), University of the Balearic Islands
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study includes an initial single-arm proof-of-concept phase to assess operational readiness and refine study procedures before the pilot trial. Approximately 30 participants are enrolled in this single-arm phase. The subsequent pilot trial uses a three-arm, parallel-group, randomised design with 132 participants. Pilot trial participants will be allocated in a 1:1:1 ratio to a control group receiving personalised baseline feedback, a mobile app-based CANVIA intervention, or the same mobile app-based intervention combined with health professional support.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Personalised baseline feedback reportParticipants 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. |
| Intervention A: mobile app intervention | Experimental | Behavioral: Personalised baseline feedback report, Behavioral: CANVIA mobile app interventionParticipants 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. |
| Intervention B: mobile app intervention plus professional support | Experimental | Behavioral: Personalised baseline feedback report, Behavioral: CANVIA mobile app intervention, Behavioral: Additional health professional supportParticipants 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. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalised baseline feedback reportThe 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. | Behavioural | Control group, Intervention A: mobile app intervention, Intervention B: mobile app intervention plus professional support |
| CANVIA mobile app interventionThe 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. | Behavioural | Intervention A: mobile app intervention, Intervention B: mobile app intervention plus professional support |
| Additional health professional supportAdditional 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. | Behavioural | Intervention B: mobile app intervention plus professional support |
Primary outcome
Proportion of invited individuals enrolled and randomised
Time frame: From invitation to baseline randomisation in the randomised pilot trial
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.
Proportion of randomised participants retained at Month 3 and Month 6
Time frame: Month 3 and Month 6
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.
Proportion of expected outcome and covariate data completed
Time frame: Baseline, Month 3 and Month 6
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
Proportion of scheduled study visits attended
Time frame: Baseline, Month 3 and Month 6
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.
Proportion of planned health professional support contacts attended
Time frame: From baseline to Month 6
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.
Number of technical incidents requiring study staff support
Time frame: From baseline to Month 6
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.
Mean overall score on the mHealth App Usability Questionnaire at Month 6
Time frame: Month 6
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.
Mean item scores on the adapted Research Participant Perception Survey-Long Form at Month 6
Time frame: Month 6
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.
Number of CANVIA mobile app logins or sessions per participant through Month 6
Time frame: From baseline to Month 6
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.
Number of active days in the CANVIA mobile app per participant through Month 6
Time frame: From baseline to Month 6
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.
Proportion of expected key in-app actions completed through Month 6
Time frame: From baseline to Month 6
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.
1 secondary outcome
Mean change in WCRF/AICR Screener score from baseline to Month 6
Time frame: Baseline and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- BackgroundSchwarzer R, Baessler J. Evaluación de la autoeficacia: adaptación española de la Escala de Autoeficacia General. Ansiedad y Estrés. 1996;2(1):1-8.
- BackgroundSchwarzer R, Jerusalem M. Generalized Self-Efficacy Scale. In: Weinman J, Wright S, Johnston M, editors. Measures in Health Psychology: A User's Portfolio. Causal and Control Beliefs. Windsor: NFER-NELSON; 1995. p. 35-37.
- BackgroundAmerican Institute for Cancer Research, World Cancer Research Fund. Diet, Nutrition, Physical Activity and Cancer: a Global Perspective. A Summary of the Third Expert Report. 2018.
- Background: PubMed 32067678Solans M, Chan DSM, Mitrou P, Norat T, Romaguera D. A systematic review and meta-analysis of the 2007 WCRF/AICR score in relation to cancer-related health outcomes. Ann Oncol. 2020 Mar;31(3):352-368. doi: 10.1016/j.annonc.2020.01.001. Epub 2020 Jan 8.
- Background: PubMed 21611868Lucas-Carrasco R. The WHO quality of life (WHOQOL) questionnaire: Spanish development and validation studies. Qual Life Res. 2012 Feb;21(1):161-5. doi: 10.1007/s11136-011-9926-3. Epub 2011 May 25.
- Background: PubMed 34183348Mellor K, Eddy S, Peckham N, Bond CM, Campbell MJ, Lancaster GA, Thabane L, Eldridge SM, Dutton SJ, Hopewell S. Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting. BMJ Open. 2021 Jun 28;11(6):e048178. doi: 10.1136/bmjopen-2020-048178.
- Background: PubMed 20105389de la Fuente-Arrillaga C, Ruiz ZV, Bes-Rastrollo M, Sampson L, Martinez-Gonzalez MA. Reproducibility of an FFQ validated in Spain. Public Health Nutr. 2010 Sep;13(9):1364-72. doi: 10.1017/S1368980009993065. Epub 2010 Jan 28.
- Background: PubMed 28249383Rodriguez-Munoz S, Corella C, Abarca-Sos A, Zaragoza J. Validation of three short physical activity questionnaires with accelerometers among university students in Spain. J Sports Med Phys Fitness. 2017 Dec;57(12):1660-1668. doi: 10.23736/S0022-4707.17.06665-8. Epub 2017 Mar 1.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 30393572Kost RG, de Rosa JC. Impact of survey length and compensation on validity, reliability, and sample characteristics for Ultrashort-, Short-, and Long-Research Participant Perception Surveys. J Clin Transl Sci. 2018 Feb;2(1):31-37. doi: 10.1017/cts.2018.18. Epub 2018 Jul 6.
- Background: PubMed 30973342Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.
- Background: PubMed 28213598Avery KN, Williamson PR, Gamble C, O'Connell Francischetto E, Metcalfe C, Davidson P, Williams H, Blazeby JM; members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open. 2017 Feb 17;7(2):e013537. doi: 10.1136/bmjopen-2016-013537.
- World Cancer Research Fund/American Institute for Cancer Research. Diet, Nutrition, Physical Activity and Cancer: a Global Perspective.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dora Romaguera Bosch, PhD principal investigator
CIBER (Consorcio de Investigación Biomédica en Red); IdISBa (Fundació Institut d'Investigació Sanitària Illes Balears)
Guillem Artigues Vives, PhD principal investigator
Conselleria de Salut, Govern de les Illes Balears
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalised baseline feedback report, CANVIA mobile app intervention and Additional health professional support in people with Dietary and Lifestyle Behaviour Change, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dora Romaguera Bosch, PhD (+34871205000 ext. 64517, mariaadoracion.romaguera@idisba.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of invited individuals enrolled and randomised (time frame: From invitation to baseline randomisation in the randomised pilot trial). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07722442, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.