Personalised Behavioural Intervention in Cancer Screening Programmes | NCT07722442

NCT07722442

Overview

NCT ID: NCT07722442
Lead Sponsor: Fundació d'investigació Sanitària de les Illes BalearsOTHER_GOV
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)
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: May 1, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 162Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Dora Romaguera Bosch, PhDContact
mariaadoracion.romaguera@idisba.es

Similar Studies

Participant Group/Arms

Control groupActive 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.

Behavioral: Personalised baseline feedback report

Intervention A: mobile app interventionExperimental

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.

Behavioral: Personalised baseline feedback report

Intervention B: mobile app intervention plus professional supportExperimental

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.