Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS

May 20, 2021 updated by: GIHeelkunde, University Hospital, Ghent

Rectal Cancer Survivorship, the Struggle of the Low Anterior Resection Syndrome (LARS). Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

69

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participants will be patients with major LARS, their informal caregivers and healthcare professionals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients with major LARS
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.
Informal caregivers
Informal caregivers of patients with major LARS
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.
Healthcare professionals
Healthcare professionals taking care for patients with LARS
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

AZ Sint-Jan AV
AZ Delta
Kom Op Tegen Kanker
AZ Sint-Lucas Gent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2016

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

December 31, 2020

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC2016/1016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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