Dataset Information

The Effect of a Colorectal Cancer Screening Decision Aid Tailored to Lower Educational Attainment Citizens

ABSTRACT: 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.

DISEASE(S): Decision Making,Knowledge, Attitudes, Practice,Colorectal Neoplasms

PROVIDER: 2252108 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Name of intervention: gender specific mail-administered screening invitation strategies. All participants will receive an offer to participate in a free FOBT which will be delivered by mail. Intervention arms will differ from control according to the information included in the materials accompanying the screening offer. All study participants will receive a standard screening reminder irrespective of their intervention group. Intervention materials will target specific psychosocial variables previously identified as being related to male participation in FOBT screening. The intervention period is 14 weeks. All participants will receive a screening offer according to the following timeline. Baseline: Advance notification letter sent Week two: Invitation package sent Week eight: Reminder letters sent to those who have not completed an FOBT Week 14: Data collection ceases. Arm 1: Control The control arm will receive a standard offer to participate in FOBT screening designed to mimic the strategy utilised by the Australian national bowel cancer screening program (NBCSP). The standard offer includes an advance notification letter and a screening invitation package. The advance notification letter is sent two weeks prior to the screening invitation package and is designed to alert participants that an invitation to screen for CRC with an FOBT will soon follow. The standard advance notification letter introduces basic information about colorectal cancer and the health benefits of screening. The screening invitation package includes a) a screening invitation letter b) an immunochemical FOBT with associated instructions c) an information booklet that describes colorectal cancer and screening and d) a particip Primary outcome(s): Rate of FOBT participation per trial arm as assessed by number of FOBT screening tests returned.[At 14 weeks from baseline, 12 weeks after receiving the FOBT.] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Factorial;Type of endpoint: Efficacy

Project description:Interventions: Eligible people (n = 240) within the SCOOP program (a colonoscopy surveillance program for individuals at higher risk for bowel cancer) at Repatriation General Hospital or Flinders Medical Centre who do not screen for bowel cancer via the standard means (ie. faecal testing), will be sent a letter to invite them to screen for bowel cancer with a blood test (Colovantage Plasma), as well as a short survey to ascertain their demographic details and their screening history. Anyone interested in taking up the blood screening test will be asked to fill in the consent form and request form and send them back (in the provided reply paid envelope) to the Bowel Health Service. Following receipt of the blood test request form, the study enrolee will then be sent further information on the blood test (including information on the accuracy of the test, where they can get their blood collected, and when they will receive their test results) and a test referral. They can then take up the offer of the free screening blood test at one of four local blood collection centres (Healthscope). They do not need to be fasted and appointments do not need to be made. Reminder letters will be sent after 6 weeks to those people who have not taken up the blood test screening offer. Screening participation rate with the blood test and demographic factors that influence uptake, will be assessed at the 12 week time point. Primary outcome(s): The primary outcome is to determine how many people within 12 weeks following the invitation letter have a blood sample collected for bowel cancer screening (ie. outcome = blood test participation rate). The number that complete the blood test will be expressed as a percentage of the invited cohort (ie. 240)[12 weeks after invitation to screen.];An additional primary outcome will be to determine the factors that predict screening uptake with the blood test, ie. age, gender, risk status for bowel cancer, reasons for not participating with faecal testing. This information will be established via a short survey (designed specifically for this study) that is provided with the original study invitation letter.[12 weeks after invitation to screen.] Study Design: Purpose: Prevention; Allocation: Non-randomised trial

Project description:CALGB 40601 was activated as a 3-arm study (paclitaxel + trastuzumab + lapatinib [THL], paclitaxel + trastuzumab [TH] and paclitaxel + lapatinib [TL]). In December 2010, twoneoadjuvant studies were presented at the Cancer Therapy and Research Center-American Association for Cancer Research (CTRC-AACR) San Antonio Breast Cancer Symposium that affected the scientific and practical enthusiasm for the TL arm. For this reason the CALGB 40601 has been amended to omit the TL treatment arm (arm 3). In the Geparquinto trial, patients with HER2-positive breast cancer received epirubicin/cyclophosphamide followed by docetaxel combined either with trastuzumab (EC-DOC-H) or lapatinib (EC-DOC-L) neoadjuvantly, then trastuzumab for a total of 12 months adjuvantly [34]. Pathologic complete response (pCR) in breast and axilla was the primary endpoint. Among 620 patients randomized, there was a higher pCR rate (31% vs 22%) and lower toxicity with fewer discontinuations (10% vs 16%) among patients on the trastuzumab arm than the lapatinib arm. The first results of the NeoALTTO trial were similar [35]. Approximately 450 women with HER2-positive breast cancer received a lead-in phase of 6 weeks of biologic therapy withlapatinib (L), trastuzumab (H), or both, then paclitaxel was added for an additional 12 weeks prior to surgery. All drugs were given at doses similar to CALGB 40601. Postoperative adjuvant therapy included additional chemotherapy and biologic therapy, however, the presentation focused solely on the primary endpoint of pCR in the breast at surgery; no longterm outcomes were presented. There were more grade > 3 adverse events in the lapatinib arm compared with the trastuzumab arm, including diarrhea (23% vs 2%), hepatic abnormalities (13% vs 1%), and neutropenia (16% vs 3%). The only death occurred in the combined biologic (LH) arm. Failure to complete treatment as planned was higher in the L (34%) and LH arms (39%) that in the H arm (u%). PCR was highest with LH-paclitaxel (51%), followed by H-paclitaxel (30%), and L-paclitaxel (25%). Based on the inferior results and higher toxicity of the investigational lapatinib arms of these studies and in discussion with CTEP, in January 2011 it was decided to amend CALGB 40601 to omit Arm 3 (TL). Those patients on this arm will complete protocol therapy as perthe original study design. In CALGB 40601, it is recommended that all patients receive trastuzumab adjuvantly for 1 year, hence all of the patients including those previously randomized to the TL neoadjuvant arm, will be able to receive the known benefit of trastuzumab. After local IRB approval of Update #5, the remainder of the patients will be enrolled and randomized to Arm 1 (THL) and Arm 2 (TH) in a 2:1 fashion. Given that TH isthe standard regimen, and is also clearly the best tolerated, we will continue that arm of thestudy as the comparator, with THL as the only investigational arm.

Project description:We will investigate the clinical implementation of genome sequencing (GS) for carrier screening to aid reproductive decision-making in adults. The study is organized into three inter-related Projects. The study population will include women and their partners who receive pre-conception testing. In Project 1, we will conduct a Randomized Clinical Trial to test clinical implementation of WGS compared with usual care. We will integrate WGS results with the electronic medical record (EMR), and measure outcomes from patient and physician perspectives. In Project 2, we will perform whole genome sequencing, including validation and interpretation of the identified variants to identify "actionable variants", meaning variants deemed worthy of reporting. This will include a robust approach using a Return of Results Committee (RORC) for determination of reportable results. In Project 3, we will evaluate the ethical and psychosocial implications of expanded carrier screening using WGS for the return of carrier status and secondary findings, and measure the impact on downstream healthcare utilization and cost. Two groups of women are identified through the electronic medical record. The first group has a clinical carrier screening test, usually Cystic Fibrosis (CF), ordered and completed as part of a preconception planning visit. The second group has a carrier screening test, usually CF, performed during pregnancy, they have delivered their baby and are planning a future pregnancy. Eligible women are randomized to either usual care or genome sequencing (GS). Women randomized into the usual care arm have already received their clinical genetic test. These women will not receive genome sequencing. Women in the GS arm will receive their carrier status results for about 700 gene/condition pairs approximately three months after randomization. If there are results to return, women come in for a genetic counseling session. If there are no results, a letter is sent in the mail. Incidental findings (IF) are returned about one month later. As with the carrier status results, all IF are returned in person, and if there are no results a letter is sent in the mail. If a participant is found to be a carrier of an autosomal recessive condition, her male partner is then eligible and invited to participate in the study and receive GS.

Project description:Background and study aims Colorectal cancer (CRC, also known as bowel cancer) is the fourth most common cancer and the second leading cause of cancer related deaths in England. Screening the at risk population for CRC by way of biennial faecal occult blood testing (FOBt) reduces CRC deaths by detecting CRC early, at a time when it is easier to treat. In England, the National Health Service (NHS) runs an organised population-based CRC screening programme (Bowel Cancer Screening Programme, BCSP), which offers biennial screening via guaiac-based faecal occult blood testing (gFOBt) to any men and women aged 60-74. With 54% overall uptake, CRC screening has the lowest uptake rate amongst all of the organised National Cancer Screening Programmes (Breast and Cervical Cancer Screening) in England. As such, there is an important need for interventions to promote uptake of FOBt in the capital to reduce inequalities in uptake. Increasing evidence demonstrates that General Practitioner (GP) endorsement promotes CRC screening uptake and there is a growing interest in the use text-message reminders to increase participation in cancer screening. The present study aims to investigate the effectiveness of a primary care based text-message reminder to promote CRC screening uptake in London. Who can participate? Adults aged between 60 to 75 who are eligible for bowel cancer screening. What does the study involve? Participants are randomly allocated to one of two groups. Participants are sent an invitation letter with screening information booklet by their local Hub. They then receive the gFOBt kit and instructions 8-10 days letter. They are asked to collect samples of three separate bowel motions and send the completed kit back to the hub. A letter is sent after four weeks of non-response. Those allocated to the first group receive a text message reminder to send their kit back. Those in the second group receive the standard screening materials. Uptake in both groups will be measured at 18 weeks and compared for statistically significant differences.

Dataset Information

The Effect of a Colorectal Cancer Screening Decision Aid Tailored to Lower Educational Attainment Citizens

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