Prevention of lung, breast, and colorrectal cancer disease in the healthy at-risk age population Cancer
Conditions
Interventions
This pilot study includes two randomisations, both carried out centrally using the REDCap platform. The first randomisation assigns subjects in a 1:1 ratio to the control and experimental groups, stra
iBC), used as a smartphone application, and the control group (CG), which will receive the usual practice recommendations (UPR). The experimental intervention will last 12 weeks. Outcomes will be obta
Sponsors
Institut Català d'Oncologia (ICO)
European Institute of Oncology
Carol Davila University of Medicine and Pharmacy
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Ability to understand and voluntarily provide signed written informed consent approved by the study site’s Institutional Review Board (IRB). 2. Being at a high-risk age for breast (women between 45-70), colorectal (individuals between 50-70) or lung cancer (individuals aged 50-80 years). 3. Having participated in a test for early detection of cancer (i.e., mammography or ultrasound for breast cancer, faecal occult blood test (FOBT) or colonoscopy for colorectal cancer, and CT-scan for lung cancer)
Exclusion criteria
Exclusion criteria: 1. History of any prior or current personal cancer diagnosis. In the case of colorectal and breast cancer, this will be restricted to the pathology tested for screening. 2. Current severe disease that may significantly compromise the performance on the study according to the criteria of the investigator. 3. Not owning a smartphone. 4. For breast and colorectal cancer, participants undergoing screening for alert symptoms or family history of these cancer types (the latest are eligible for specific hereditary cancer programs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure of this pilot study is its feasibility, which will be assessed through the following variables: 1. Recruitment capability will be measured by collecting the recruitment numbers and rate per centre and in total for the pilot study duration. Potential difficulties in the recruitment process will be registered and analysed. Also, the resulting sample characteristics will be studied according to demographic variables. 2. The integrity of the data collection procedures and outcome measures will be measured using the completion of study questionnaires at baseline and after 12 weeks at the end of the intervention 3. The acceptability and suitability of intervention and study procedures will be measured by the System Usability scale and open-ended feedback at the end of the intervention from participants in the experimental group 4. The resources and ability to manage and implement the study and intervention will be measured using the feedback from study personnel on the workload and areas for improvement collected for further analysis and development of mitigation strategies to implement in the larger RCT. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are the preliminary effectiveness and cost-effectiveness of iBeChange in achieving a sustainable behavioural change in smoking, alcohol consumption, nutrition, physical activity habits, and emotional well-being symptoms at baseline, and the end of the intervention (12 weeks), unless stated: 1. Behavioural change in Smoking habits is measured using seven-day point prevalence abstinence, average of cigarettes smoked per day in the past seven days, and the Fagerström test for Nicotine Dependence (FTND) by all participants 2. Behavioural change in Alcohol consumption habits is measured using the Alcohol Use Disorders Identification Test by all participants 3. Behavioural change in Nutrition habits is measured using the Nutri S-Can scale by all participants 4. Behavioural change in Physical activity is measured using the Global Physical Activity Questionnaire (GPAQ) by all participants 5. Emotional distress is measured using the Emotional Distress Thermometer – 0-10 Visual Analogue Scale (VAS) by all participants 6. Perceived Stress is measured using the Perceived Stress Scale (PSS-4) by all participants 7 i 8. Anxiety and Depression are measured using the Patient Health Questionnaire (PHQ-4) by all participants 9. Social support is measured using one item from the Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences (One item from PRAPARE) by all participants 10. Insomnia is measured using item #3 of the Patient Health Questionnaire (PHQ-9) by all participants 11. Usability of the iBeChange intervention (with or without the Oura ring) is measured using the System Usability Scale (SUS) at the end of the intervention (12 weeks) from participants in the experimental group. 12. Cost-effectiveness is measured using an ad-hoc questionnaire for this project, assessing household income, healthcare costs, behaviour-related costs, and working situation | — |
Countries
Italy, Romania, Spain
Contacts
Public ContactAnna García-Serra
Outcome results
None listed