Personalised Behavioural Intervention in Cancer Screening Programmes

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Personalised 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 th
• Поведенческое CANVIA 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 u
• Поведенческое Additional 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

Первичные конечные точки

• Proportion of invited individuals enrolled and randomised [Срок оценки: From invitation to baseline randomisation in the randomised pilot trial]
• Proportion of randomised participants retained at Month 3 and Month 6 [Срок оценки: Month 3 and Month 6]
• Proportion of expected outcome and covariate data completed [Срок оценки: Baseline, Month 3 and Month 6]
• Proportion of scheduled study visits attended [Срок оценки: Baseline, Month 3 and Month 6]
• Proportion of planned health professional support contacts attended [Срок оценки: From baseline to Month 6]
• Number of technical incidents requiring study staff support [Срок оценки: From baseline to Month 6]
• Mean overall score on the mHealth App Usability Questionnaire at Month 6 [Срок оценки: Month 6]
• Mean item scores on the adapted Research Participant Perception Survey-Long Form at Month 6 [Срок оценки: Month 6]
• Number of CANVIA mobile app logins or sessions per participant through Month 6 [Срок оценки: From baseline to Month 6]
• Number of active days in the CANVIA mobile app per participant through Month 6 [Срок оценки: From baseline to Month 6]

Вторичные конечные точки (1)

• Mean change in WCRF/AICR Screener score from baseline to Month 6 [Срок оценки: Baseline and Month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Fundació Institut d'Investigació Sanitària Illes Balears — Palma de Mallorca

Публикации

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• 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.
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Идентификаторы

NCT: NCT07722442 · PI24/01647 · IB 6026/26 PI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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