Breast and prostate cancers Cancer
Conditions
Interventions
After completing the online eligibility screening questionnaire, consent form and baseline questionnaire assessing sociodemographic, health-related and psychosocial variables, participants will be ran
Sponsors
CHU de Québec-Université Laval
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Breast cancer-free adult women with one or more of the following characteristics : 1. Having a first-degree family history of breast cancer 2. Personal history of breast atypical hyperplasia 3. An extreme breast density 4. Being a mutation carrier in high or moderate penetrance genes. Prostate cancer-free adult men with one or more of the following characteristics : 1. Being an African-descent origin 2. Being a BCRA1/2 mutation carrier 3. Having an elevated prostate-specific antigen. 4. Having a first-degree family history of prostate cancer.
Exclusion criteria
Exclusion criteria: 1. Personal history of any cancer 2. Participation in a clinical study on primary prevention of breast cancer and prostate cancer 3. Engaged in a decision-making process regarding breast cancer and prostate cancer preventive measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at 6 months post-randomization through an online questionnaire: 1. Intentions to uptake primary preventive measures for breast cancer or prostate cancer: For the intervention group, the question « Based on what you know right now, how likely do you think you are to take each of the following prevention options for breast cancer (or prostate cancer) recommended to you? » will be asked. For the control group, the question « Based on what you know right now, how likely do you think you are to take one of the following breast cancer (or prostate cancer) prevention measure » will be asked. A five-point Likert-type response scale will be used for these questions. 2. Actual uptake of primary preventive measures for breast cancer or prostate cancer: « Have you made a decision about whether or not you are going to take any of the prevention options for breast cancer (or prostate cancer) recommended to you? » or « Have you made a decision about whether or not you are going to take any of the prevention measures for breast cancer (or prostate cancer)? » Those who respond that they made a decision will be asked « Did you actually take the option or the measure? And how? », those who did not made a decision will be asked « How close are you to making a decision? » 3. Decision regret: Both groups will be asked to complete the French or English version of the Decision Regret Scale (Brehaut, Medical Decision Making, 2003). This scale comprises 5 statements for which respondents are selecting a number from 1 (Strongly Agree) to 5 (Strongly Disagree) that best indicates their level of agreement. Scores are converted on a scale of 0 to 100 with a score of 0 meaning no regret and a score of 100 meaning high regret. | — |
Secondary
| Measure | Time frame |
|---|---|
| Collected through online questionnaires at two time points: baseline (pre-randomization) and 6 months post-randomization. 1. Feasibility of the study: Participation rates, appropriateness of randomization process, number of participants who use the study materials, and completion of data collection tools will be tracked throughout the study. 2. Feasibility and acceptability of the intervention: The acceptability of the intervention will be measured at T2 by assessing the satisfaction of participants with the intervention materials. Semi-structured interviews will be used to elicit participants’ perspectives regarding the intervention. 3. Clinical and biological measures: Upon consent, levels of PSA in men and breast density in women will be extracted from participants’ medical charts at T2, whether or not participants have taken preventive measures. The acceptability for participants to provide a blood specimen at follow-up (T2) to assess inflammatory markers, insulin like growth factor, steroid hormones, metabolites levels and DNA methylation will be tested and whether some of these measures could be linked to the uptake of preventive measures status will be explored. | — |
Countries
Canada
Contacts
Public ContactAsma Boubaker
Outcome results
None listed