Evaluation of a Decision Aid Tool in Rectal Cancer patiënts

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

Study Overview

• Status: Completed
• Conditions: Low Anterior Resection Syndrome; Rectal Cancer
• Intervention / Treatment: Behavioral: Delphi Procedure and interviews

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients with rectal cancer healthcare professionals caring for patients with rectal cancer informal carers of patients with rectal cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
expert healthcare professionals; Delphi Procedure	Behavioral: Delphi Procedure and interviews; Delphi procedure with expert healthcare professionals and interviews with patients, healthcare professionals and informal carers
healthcare professionals, patients and informal carers; interviews	Behavioral: Delphi Procedure and interviews; Delphi procedure with expert healthcare professionals and interviews with patients, healthcare professionals and informal carers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: AZ Sint-Jan AV; AZ Delta; Kom Op Tegen Kanker; AZ Sint-Lucas Gent
• Investigators: Principal Investigator: Piet Pattyn, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: low anterior resection syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Low Anterior Resection Syndrome
• Other Study ID Numbers: BC-10030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No