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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04896879
Other study ID # EC2016/1016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 22, 2016
Est. completion date December 31, 2020

Study information

Verified date May 2021
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Exploration of the experiences and needs of patients with the low anterior resection syndrome, their informal caregiver and health care professionals. This is a qualitative study where semi-structured interviews will be conducted with patients and informal caregivers. next to that focus groups will be performed with healthcare professionals from different professions.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility PATIENTS Inclusion Criteria: - adult patients (18+) - confronted with major low anterior resection syndrome after rectal cancer surgery Exclusion Criteria: - stoma at time interview - abdominal perineal resection INFORMAL CAREGIVERS Inclusion criteria - Adults (18+) - Nominated by the participating patient as their principal caregiver Exclusion criteria None HEALTHCARE PROFESSIONALS inclusion criteria - Adults (18+) - Caring for patients with LARS Exclusion criteria None

Study Design


Intervention

Behavioral:
interviews
semi-structured interviews will be conducted in patients with major LARS and their informal caregiver to explore their experiences and needs. Focus groups will be perfomed with healthcare professionals of several professions.

Locations

Country Name City State
n/a

Sponsors (5)

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

Outcome

Type Measure Description Time frame Safety issue
Primary needs and experiences of patients with major lars and their informal caregiver through individual semistructered interviews Exploring needs and experiences of patients with major lars and their informal caregiver through individual semistructured interviews Interview will last about 60 minutes
Primary Needs and experiences of healthcare professionals caring for patients with LARS through focus groups Exploring needs and experiences of healthcare professionals caring for patients with LARS Focus group will last about 60 minutes
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