NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Personalised Behavioural Intervention in Cancer Screening Programmes
Personalised Behavioural Intervention in Cancer Screening Programmes

NCT07722442

Not Yet RecruitingNA

Sponsor: Fundació d'investigació Sanitària de les Illes Balears

Conditions: Dietary and Lifestyle Behaviour Change

Interventions: Personalised baseline feedback report, CANVIA mobile app intervention, Additional health professional support

Countries: Spain

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 overview

Sex: ALL

Age: 50 Years to 69 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (1)
  • Palma de Mallorca, Balearic Islands, Spain