Dietary and Lifestyle Behaviour Change
Conditions
Keywords
Cancer prevention recommendations, Behavioural intervention, Lifestyle intervention, Mobile health, Feasibility studies
Brief 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). 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.
Interventions
BEHAVIORALPersonalised baseline feedback report
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.
BEHAVIORALCANVIA mobile app intervention
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.
BEHAVIORALAdditional health professional support
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.
Sponsors
Fundació d'investigació Sanitària de les Illes Balears
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 (Universidad de las Islas Baleares)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
The study is open-label at the participant, care provider, investigator, and outcome assessor levels. The statistician performing the analysis of intervention effects will receive the study groups coded as A, B, and C and will remain blinded to the identity of the treatment groups during the prespecified statistical analyses.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of invited individuals enrolled and randomised | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in WCRF/AICR Screener score from baseline to Month 6 | Baseline and 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. |
Countries
Spain
Contacts
CONTACTDora Romaguera Bosch, PhD
CONTACTLeón González Casas, Máster
PRINCIPAL_INVESTIGATORDora Romaguera Bosch, PhD
CIBER (Consorcio de Investigación Biomédica en Red); IdISBa (Fundació Institut d'Investigació Sanitària Illes Balears)
PRINCIPAL_INVESTIGATORGuillem Artigues Vives, PhD
Conselleria de Salut, Govern de les Illes Balears
Outcome results
None listed