An interventional study of Intervention brochure and Control brochure in Colorectal Cancer, sponsored by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 50 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland · Not applicable, Interventional, and Prevention
The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC.
The secondary objectives:
The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of participants' risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to a participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels.
This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance.
Colorectal cancer (CRC) can be effectively prevented by screening. Risk to develop CRC within 15 years is related to increasing age, sex, family history, and lifestyle and, thus, can vary from \<1% to >15%.
Fecal immunochemical test (FIT) and colonoscopy are the most widely used screening tests. Colonoscopy is the most accurate test, but is related to risks of bleeding and perforation. Colonoscopy resources are limited, and high uptake of screening colonoscopy for low-risk individuals can cause long wait times for those with CRC symptoms or positive FIT. FIT is less costly can be done at home without preparation and, if done regularly, prevents most CRC mortality, especially in moderate and low-risk individuals. To offer the screening options with a reasonable risk-benefit balance, FIT should be recommended to individuals at low (\<3% to develop CRC in 15 years) and moderate (3-6%) risk, and colonoscopy to those at high (>6%) risk.
The primary objective is to study the effect of communicating individual CRC risk score and screening recommendations on appropriate screening uptake at six months in individuals at low, moderate and high risk of developing CRC.
The secondary objectives:
The investigators will perform a pilot randomized controlled trial (RCT) of 880 residents from the canton Vaud (Switzerland) aged between 50 and 69 years. The QCancer calculator will be used to calculate the personalized risk score. The participants in the intervention group will receive a brochure with a personalized risk score and appropriate screening recommendations. The participants in the control group will receive the standard brochure of the Vaud CRC screening program, regardless of the participant's risk level. Six months after the intervention, the investigators will measure the proportion of the participants who have undergone appropriate screening. Screening will be considered as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake FIT. Both tests are appropriate for participants at moderate-risk. The hypothesis is that in the intervention group, individuals will be more likely to undergo screening appropriate to participant's individual risk level, whereas the choice of the screening test in the control group will not differ between risk levels.
This study should advance the field of risk-based screening. This may give insights about how to optimize CRC screening programs and offer to the population screening options with a better risk-benefit balance.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 515 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland is the lead sponsor of 22 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Participants in the Intervention group receive a brochure with their personalized risk score for colorectal cancer and screening recommendations (FIT or colonoscopy) corresponding to their risk level.
Behavioral: Intervention brochure
Participants in the Usual care group receive the standard brochure designed by the Vaud screening program. This brochure recommends screening to all individuals beginning at age 50 and presents both FIT and colonoscopy as equal options.
Behavioral: Control brochure
Provide participants with information about their personalized risk for colorectal cancer and appropriate screening recommendations to facilitate their screening option choice.
Provide participants with general information about options for colorectal cancer screening.
Self-reported appropriate screening uptake
Proportion who completed screening test appropriate to risk level. For low risk (\<3% 15-yr CRC risk), completing a FIT. For intermediate risk (3-6%15-yr CRC risk), completing a FIT, completing a colonoscopy, or having a colonoscopy appointment. For high risk (\>6% 15-yr CRC risk), completing a colonoscopy or having a colonoscopy appointment.
Time frame: 6-8 months after the intervention
Self-reported overall screening participation
Proportion who completed any CRC screening test (FIT, colonoscopy, colonoscopy appointment, CT colonography, blood test, etc.
Time frame: 6-8 months after the intervention
Participation in the randomized trial
Proportion of those invited with completed paper or electronic consent
Time frame: 6 weeks after mailed invitations
Eligibility for the Vaud CRC screening program
Proportion of those who returned the baseline questionnaire who are eligible for the Vaud screening program (i.e. not up-to-date with screening, not in colonoscopy surveillance, no personal CRC history, etc.)
Time frame: 6 weeks after mailed invitations
Self-reported anxiety
Mean anxiety score using adapted questions from a standardized questionnaire (STAI Fr)
Time frame: 6 weeks after mailed invitations
Linkage to Vaud CRC screening program
Proportion of study participants who consent and whose screening status are obtained from the Vaud CRC screening program
Time frame: 3-6 months after measurement of primary outcome
Linkage to Vaud tumor registry
Proportion of study participants who consent and whose cancer status are obtained from the Vaud tumor registry. Long time frame chosen given considerable delay in updating the tumor registry and interest in cancer outcomes several years after measurement of primary outcome.
Time frame: 6 months to 10 years after measurement of primary outcome
Plan to share: Yes — Upon publication of the primary results, the data that support the findings of this study will be available from the corresponding author upon reasonable request.
Supporting information: Study protocol, Icf
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland