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The development and evaluation of two decision aids for individuals considering genetic testing for hereditary cancer.

ABSTRACT: Interventions: The study aims to compare the efficacy of an educational pamphlet currently used in the clinical setting to that of the decision aids using two randomised controlled trials. The decision aids will be tested with two different samples: 120 individuals at high risk for HNPCC and 120 members of high-risk breast cancer families who approach one of six familial cancer clinics who have agreed to participate in this study (the familial cancer clinics in NSW: at Prince of Wales, Westmead, St Vincents Hospitals and Hunter Genetics, Newcastle, and in Victoria: at Royal Melbourne Hospital, and the Peter McCallum Cancer Institute). Participants will complete a questionnaire after they have read the decision aid or pamphlet, followed by a second questionnaire after 6 months. Primary outcome(s): The primary outcome for the study is decisional conflict (measured by the Decisional Conflict Scale). This scale measures uncertainty about choosing among alternatives; modifiable factors contributing to uncertainty, such as being uninformed and unclear about values and feeling unsupported in decision-making, and perceptions of effectiveness of decision-making[Assessed immediately after reading the information materials provided, and in the 6-month follow up questionnaire.] Study Design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Hereditary Non-polyposis Colorectal Cancer (hnpcc),Cancer-ovarian And Primary Peritoneal,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Hereditary Breast/ovarian Cancer,Cancer-breast

PROVIDER: 2452387 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention 1: Intervention group1: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet, film and free access to fecal occult blood test. Intervention 2: Intervention group2: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet and film. Intervention 3: Intervention group3: free access to fecal occult blood test. Intervention 4: Control group: For the control group will not perform any of the action that will be taken for the intervention group.;Prevention;Prevention;Prevention;Prevention;Intervention group1: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet, film and free access to fecal occult blood test;Intervention group2: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet and film;Intervention group3: free access to fecal occult blood test;Control group: For the control group will not perform any of the action that will be taken for the intervention group. Primary outcome(s): Perceived severity. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Knowledge. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived susceptibility. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Intention. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived barriers. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Social support. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Self efficacy. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived benefits. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire. Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening.

Project description:The aim of the trial is to test the effect of a web-based decision aid (DA) on colorectal cancer (CRC) knowledge, decisional conflict, participation rate, and informed choice (evaluated based on knowledge, attitudes and actual participation). The study includes three study arms. Citizens to be recruited are identified from the Danish Civil Registration System based on residence (Central Denmark Region), age (50-74 years old), and month of birth. A random sample of 15,000 citizens born in December (invited for CRC screening through October/November/December 2017) (study arm 1+2) and 5,000 citizens born in October (invited for CRC screening in January/February 2017) (study arm 3) is identified. Citizens in study arm 1+2 will receive a baseline questionnaire assessing knowledge, attitudes, worry, and health literacy. Non respondents will receive one reminder after two weeks and after four weeks non-respondents will receive a phone call, offering them to fill out the questionnaire via the phone. Baseline questionnaire respondents are included in the study, and will be randomized into two study arms (intervention group and control group). Citizens in the intervention group will be identified in the screening IT system. Date of screening invitation and screening reminder (citizens who do not return a stool sample within 45 days of the screening invitation) is retrieved. Citizens receiving a screening reminder will receive a link for the DA. Follow-up questionnaire will be sent to all included citizens in study-arm 1+2 three months after the last screening invitation has been sent out. Citizens have six weeks to respond to the questionnaire. Study arm 3 is a historic cohort. The citizens receive only one questionnaire at the same time as the baseline questionnaires are sent out to the intervention and control groups. The citizens are included if they respond to the questionnaire within six weeks. Questionnaire reminders are sent out at two and four weeks. Data on screening invitation date, screening reminder date, returning a stool sample and result will be retrieved from the screening IT system for all included citizens (Study arm 1-3). Lastly, data from Statistics Denmark (on socio-demographic and socio-economic factors) will be included.

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The development and evaluation of two decision aids for individuals considering genetic testing for hereditary cancer.

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