Personalised Behavioural Intervention in Cancer Screening Programmes

ConditionDietary and Lifestyle Behaviour Change

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50-69

SponsorFundació d'investigació Sanitària de les Illes Balears

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Personalised baseline feedback report
Behavioral
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 intervention
Behavioral
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
Behavioral
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.

Treatment groups

162 Participants

are divided into 3 treatment groups

Group A: Control groupActive comparator 1 intervention

Group B: Intervention A: mobile app interventionExperimental treatment 2 interventions

Group C: Intervention B: mobile app intervention plus professional supportExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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

Time frame

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.

Time frame

Baseline, Month 3 and Month 6

Secondary outcomes

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.

Time frame

Baseline and Month 6

Other outcomes

Themes describing participant experiences from Month 6 focus groups

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.

Time frame

Month 6

Sponsors and contacts

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Fundació d'investigació Sanitària de les Illes Balears

Lead sponsor

Instituto de Salud Carlos III

Collaborator

Conselleria de Salut, Govern de les Illes Balears

Collaborator

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Collaborator

University of the Balearic Islands (Universidad de las Islas Baleares)

Collaborator

Source ClinicalTrials.gov

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