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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Proportion of invited individuals enrolled and randomised
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Proportion of invited individuals enrolled and randomised
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Mean change in WCRF/AICR Screener score from baseline to Month 6(Baseline and Month 6)