NCT04896879

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2016

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

4.1 years

First QC Date

December 31, 2020

Last Update Submit

May 20, 2021

Conditions

Low Anterior Resection SyndromeRectal Cancer

Keywords

low anterior resection syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Patients

Patients with major LARS

Behavioral: interviews

Informal caregivers

Informal caregivers of patients with major LARS

Behavioral: interviews

Healthcare professionals

Healthcare professionals taking care for patients with LARS

Behavioral: interviews

Interventions

interviewsBEHAVIORAL

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 professionalsInformal caregiversPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • adult patients (18+)
  • confronted with major low anterior resection syndrome after rectal cancer surgery

You may not qualify if:

  • stoma at time interview
  • abdominal perineal resection
  • Adults (18+)
  • Adults (18+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pape E, Decoene E, Debrauwere M, Van Nieuwenhove Y, Pattyn P, Feryn T, Pattyn PRL, Verhaeghe S, Van Hecke A; Belgian LARS collaborative group. Information and counselling needs of patients with major low anterior resection syndrome: A qualitative study. J Clin Nurs. 2023 Apr;32(7-8):1240-1250. doi: 10.1111/jocn.16277. Epub 2022 Mar 6.

    PMID: 35253296DERIVED

MeSH Terms

Conditions

Low Anterior Resection SyndromeRectal Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 31, 2020

First Posted

May 21, 2021

Study Start

November 22, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 21, 2021

Record last verified: 2021-05