Evaluation of a Decision Aid Tool in Rectal Cancer patiënts

NCT04938336 | Completed

• 1 other identifier: BC-10030
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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

Conditions

Low Anterior Resection Syndrome; Rectal Cancer

Keywords

low anterior resection syndrome

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

expert healthcare professionals

Delphi Procedure

Behavioral: Delphi Procedure and interviews

healthcare professionals, patients and informal carers

interviews

Behavioral: Delphi Procedure and interviews

Interventions

Delphi Procedure and interviews BEHAVIORAL

Delphi procedure with expert healthcare professionals and interviews with patients, healthcare professionals and informal carers

expert healthcare professionals; healthcare professionals, patients and informal carers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• expert healthcare professionals caring for patients with rectal cancer

You may not qualify if:

• none
• 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
• patients who have no treatment choice due to oncological reasons

Sponsors & Collaborators

• University Hospital, Ghent: lead
• AZ Sint-Lucas Gent: collaborator
• AZ Sint-Jan AV: collaborator
• AZ Delta: collaborator
• Kom Op Tegen Kanker: collaborator

Study Sites (2)

University hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Piet Pattyn

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 24, 2021
• Study Start: April 22, 2022
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

BE (2)