ICIBS Trial - Improving Patient Information About Bowel Cancer Screening - a Decision Aid Trial
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Neoplasms,Colorectal Cancer Screening
PROVIDER: 2015614 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Studies evaluating decisions aids have used a wide range of outcome measures as well as formats and settings. Most studies have focused on patient decision aids used either within the consultation or delivered pre-consultation, but there are no randomised, controlled studies comparing the two. However, timing and format of the patient decision aid intervention may affect how useful the tool is to the patient. The aim of this project is therefore to deepen our understanding of the patient’s engagement in and preparation for the decision making process in a randomised, controlled trial comparing an electronic pre-consultation and paper-based in-consultation patient decision aid. 274 patients with colorectal and breast cancer are enrolled in the study. Data are collected at both patient and consultant perceived levels as well as an observed level of shared decision making.
| 2750869 | ecrin-mdr-crc
Project description: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
| 2452387 | ecrin-mdr-crc
Project description:Background and study aims
Colorectal cancer (CRC) ranks first in males and third in females among all cancers in Saudi Arabia (SA). CRC incidence and related deaths have been steadily increasing in SA over the past 20 years. Care for a metastatic colorectal cancer patient is a complex process. It could include chemotherapy, palliation, and surgery. The possible benefit frequently comes at the cost of toxicity, hospitalization, and sometimes-critical care. Previous studies reported that 28.2% of patients diagnosed were distant metastasis. Decision aids (DAs) are tools used to improve communicating information between health providers and patients and to involve patients in decisions about their health care. Cancer-related decisions can be difficult due to diagnosis anxiety, denial, and lack of effective communication. Several studies have shown that the use of decision aids help in improving patients’ knowledge and satisfaction. Although the evidence of benefits of DAs is available for breast cancer and colon cancer patients, no study has been found to show the usefulness of an Arabic decision aids within the Arab culture. The aim of this study is to evaluate the effect of a decision aid (DA) designed for metastatic colorectal cancer patients in the Arabic language.
Who can participate?
Patients aged 21 to 75 attending the outpatient clinic newly diagnosed with metastatic colorectal cancer
What does the study involve?
Participants are randomly allocated to receive a visual decision aid tool alongside standard care or standard care alone (all information provided by physician). The researchers measure the effect on a patient’s decision making, anxiety level and understanding of metastatic colorectal cancer.
| 2409336 | ecrin-mdr-crc
Project description:Interventions: Use of a decision aid during the consultation by the medical oncologist and provision of the decision aid and audiotape for patient to take home. The decision aid contains information on potential managment decisions, risks and benefits of treatment options, side effects, treatment regimes, survival statistics, pros and cons of choices. The duration of use of the DA in the consultation is not set, it may be used as long as is required. The audiotapes is a recording of the content of the booklet. Participants may listen or read the decision aid as often as they wish and the DA and audiotape are theirs to keep.
Consultation length is as long as required.
Primary outcome(s): Enhanced patient achievement of information and involvement preferences and more active involvement in treatment decision-making following use of the decision aid.[Measured immediately post consultation and 2 weeks post decision.]
Study Design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy
| 2453185 | ecrin-mdr-crc
Project description:This trial examines cancer communication within Hispanic social networks. Hispanics have the lowest colorectal cancer screening rate of any major ethnic group and health interventions are crucially needed among Hispanics. Patient decision aids are health communication interventions designed to provide patients with targeted health information and have shown to improve colorectal cancer screening rates among Hispanics. The goal of this study is to investigate, in a sample of Hispanics, how a colorectal cancer decision aid aimed at increasing individuals’ colorectal cancer screening behavior has effects on their alters’ intention to get screened for colorectal cancer.
| 2343521 | ecrin-mdr-crc
Project description:Interventions: This study aims to test the efficacy of a decision aid, using an expected frequency tree which visually displays statistics and further provides numerical evidence and to present the benefits and harms of low dose aspirin, on informed decision making and uptake of aspirin in general practice.
a) Description of the decision aid: The male and female decision aids are brochures with an accompanying 3-minute video. The video is designed to be talked through with the participants in a consultation with a research assistant and it covers the exact information which is found in the hard copy brochure. The video and brochure formats of the decision aid is designed to communicate the benefits and risks of taking low-dose aspirin, 100 – 300 mg per day, as defined by the Cancer Council Australia, to the participants. Each participant will be given the hard copy of the decision aid to take with them after the consultation with the research assistant. The decision aid also prompts the participants to speak with their general practitioner following their consultation with the research assistant as taking aspirin may or may not be right for them.
Primary outcome(s): The primary outcome is self-reported daily adherence to aspirin as assessed by a 6 month follow up a questionnaire which has been designed specifically for this study.[6 months after enrollment];The second primary outcome is participants ability to make an informed choice as measured by the validated scale called the Multi-dimensional Measure of Informed Choice asks about participants knowledge, attitudes and behaviour which is asked in the 1-month follow up questionnaire. [1-month after enrollment ]
Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy
| 2471220 | ecrin-mdr-crc
Project description:This trial studies how well a decision aid website works in helping to make decisions about fertility in participants with cancer. Decision aid websites that provide information about fertility preservation (maintaining your ability to have children of your own after cancer treatment) may help participants with cancer make fertility-preservation decisions.
| 2243478 | ecrin-mdr-crc
Project description:Interventions: Participants in the intervention conditions receive ONE of ethier an internet-based tailored decision support intervention, or internet-based non-tailored decision support intervention. In each intervention, participants answer questions concerning their perceived susceptibility to Colorectal cancer (CRC) and attitudes towards CRC screening. Tailored responses are then generated for the ‘tailored group’ which are designed to correct misaprehensions where they exist. For the non-tailored group participants do not receive tailored messages but rather generic information brochures concerning Colorectal cancer. This intervention is accessed once only and participants work through it at their own pace. The overall duration of the study will be approximately 12 months.
Primary outcome(s): Number of participants completing a colorectal cancer screening test per group. All participants receive a free Colorectal Cancer screening test and the number of kits returned per study arm is recorded upon return of the kit[approximately one year after randomisation]
Study Design: Purpose: Prevention; Allocation: Randomised controlled trial
| 2455497 | ecrin-mdr-crc
Project description:Experts believe that increasing the low uptake of screening for colorectal cancer (CRC) requires educating patients about all approved tests and helping them choose one that fits their preferences. As one motto puts it: "The best test is the one that gets done." Screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). But it is unclear how best to educate patients about the options and the tradeoffs involved. Some guidelines recommend that decision aids, a promising tool in this area, provide patients with detailed quantitative information, including baseline risk, risk reduction, and chance of negative outcomes. But this sort of "comparative effectiveness" data can confuse patients, especially those with limited mathematical ability. Previous studies have not measured the effect of providing quantitative information to patients with varying levels of ability or interest or asked them whether such data is essential for their decision-making.
The investigators will conduct a clinical trial to determine the impact on patients who view a decision aid (DA) that includes quantitative information versus a DA without such data. The investigators will also seek to determine whether numeracy moderates the effect of quantitative information.
| 2192578 | ecrin-mdr-crc
Project description:The purpose of this study is to evaluate a decision aid (written information booklet designed to facilitate informed decision making) to help people aged 55-64 years, with low levels of education and literacy, make an informed choice about bowel cancer screening, using faecal occult blood testing.
| 2062056 | ecrin-mdr-crc