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Spots Global Cancer Trial Database for Evaluation of a Decision Aid Tool in Rectal Cancer patiënts

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Trial Identification

Brief Title: Evaluation of a Decision Aid Tool in Rectal Cancer patiënts

Official Title: Evaluation of a Decision Aid Tool in Rectal Cancer patiënts

Study ID: NCT04938336

Study Description

Brief Summary: Adapt and evaluate a decision aid for patients with rectal cancer. Phase 1 : decision aid testing (Delphi) multicentric Phase 2: pilot test decision aid

Detailed Description: Adapt and evaluate a decision aid for patients with rectal cancer. Phase1: decision aid testing (Delphi) A pilot version of the Belgian decision aid was developed and validated through a double Delphi procedure. In this study, the assessment is extended to several multicentre experts. The panel consists of ten experts who have extensive knowledge in the field of rectal cancer or scientific research. They are asked to evaluate the information and questions on accuracy, clarity, readability and relevance. They score the items of the decision aid using a 4-point Likert-type scale (one (one = totally irrelevant; four = very relevant) and a dichotomous scale (one = clear, two = not clear) to assess relevance and clarity of wording, respectively (see Appendix 2 to this application). To quantify the degree of content validity, the Content Validity Index (CVI) is used. Phase2: pilot test decision aid The final step of the study is a pilot test of the decision aid with patients who will undergo surgery/watch and wait strategy in the near future and with healthcare professionals who work with the decision aid. The aim is to test the acceptability of the decision aid with the patient and the ease of use with the healthcare professional. With the feedback from the patients and the healthcare professional, the decision aid can be further refined. During the consultation in which the intervention is discussed, the consent to participate will be asked of the patient and also of the informal carer who may be present at that moment. Participation in the study means that during this consultation, the caregiver involved will go through the decision aid completely with the patient and any informal carer. After the intervention, they will be asked to give feedback on their experiences with the use of the decision aid. This will be done by means of an interview for the patients, informal carers and care workers involved. The interview with the patient (and informal carer if applicable) will take place at home or in the hospital, depending on their preference. The interview with the caregiver takes place in the hospital where the caregiver works. If the current Covid-19 pandemic does not allow for a visit to the patient's home or to another hospital, the interviews will be conducted by telephone or video call.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University hospital Ghent, Ghent, Oost-Vlaanderen, Belgium

University Hospital Ghent, Ghent, , Belgium

Contact Details

Name: Piet Pattyn

Affiliation: University Hospital, Ghent

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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