Evaluation of a Decision Aid Tool in Rectal Cancer patiënts

Rectal Cancer Clinical Trial

Official title:

Evaluation of a Decision Aid Tool in Rectal Cancer patiënts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938336
• Other study ID #: BC-10030
• Status: Recruiting
• Start date: April 22, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Ghent
• Contact: Eva pape
• Phone: 003293321933
• Email: eva.pape[@]uzgent.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Delphi procedure

Inclusion Criteria:

• expert healthcare professionals caring for patients with rectal cancer

Exclusion Criteria:

• none

Interviews Inclusion criteria

• Patients in which the decision aid was tested

• patients with a tumor in the last 10cm of the rectum

• healthcare professionals who have used the decision aid tool

• informal carer indicated by the patient Exclusion

• patients who have no treatment choice due to oncological reasons

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Rectal Cancer
• Rectal Neoplasms

Intervention

Behavioral:
• Delphi Procedure and interviews
Delphi procedure with expert healthcare professionals and interviews with patients, healthcare professionals and informal carers

Locations

Country	Name	City	State
Belgium	University hospital Ghent	Ghent	Oost-Vlaanderen
Belgium	University Hospital Ghent	Ghent

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Ghent	AZ Delta, AZ Sint-Jan AV, AZ Sint-Lucas Gent, Kom Op Tegen Kanker

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of accuracy of the decision aid tool trough a delphi procedure	Assessment of accuracy of the decision aid tool through a delphi procedure	2-3 months (until consensus)
Primary	Assessment of clarity of the decision aid tool trough a delphi procedure	Assessment of clarity of the decision aid tool trough a delphi procedure	2-3 months (until consensus)
Primary	Assessment of relevance of the decision aid tool trough a delphi procedure	Assessment of relevance of the decision aid tool trough a delphi procedure	2-3 months (until consensus)
Primary	Assessment of readability of the decision aid tool trough a delphi procedure	Assessment of readability of the decision aid tool trough a delphi procedure	2-3 months (until consensus)
Primary	Assessment of the acceptability of the decision aid tool through individual interview	Assessment of the acceptability of the decision aid tool through individual interview	about 60 minutes
Primary	Assessment of the usability of the decision aid tool through individual interviews	Assessment of the usability of the decision aid tool through individual interviews	about 60 minutes