Low Anterior Resection SyndromeNCT04896879
Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
An observational study of Low Anterior Resection Syndrome and Rectal Cancer, run by University Hospital, Ghent.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome, Rectal Cancer
- What is being tested?
- interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 22 Nov 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will be patients with major LARS, their informal caregivers and healthcare professionals
Who may be able to join
- adult patients (18+)
- confronted with major low anterior resection syndrome after rectal cancer surgery
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Low Anterior Resection Syndrome, Rectal Cancer
- Being tested
- interviews
- Keywords
- low anterior resection syndrome
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with major LARS Receives: Behavioral: interviews | |
| Informal caregivers | Informal caregivers of patients with major LARS Receives: Behavioral: interviews | |
| Healthcare professionals | Healthcare professionals taking care for patients with LARS Receives: Behavioral: interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Focus group will last about 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start22 Nov 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Kom Op Tegen Kanker, AZ Sint-Jan AV, AZ Delta, AZ Sint-Lucas Gent
- Responsible party
- Principal investigator, GIHeelkunde, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896879
- Sponsor's protocol ID
- EC2016/1016
- Status last verified
- May 2021
- First submitted
- 31 Dec 2020
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35253296
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Cancer Survivorship, the Struggle of the Low Anterior Resection Syndrome (LARS). Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals
- ClinicalTrials.gov ID
- NCT04896879
- Acronym / sponsor ID
- EC2016/1016
- Conditions
- Low Anterior Resection Syndrome, Rectal Cancer
- Keywords
- low anterior resection syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Kom Op Tegen Kanker, AZ Sint-Jan AV, AZ Delta, AZ Sint-Lucas Gent
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: interviewsPatients with major LARS |
| Informal caregivers | – | Behavioral: interviewsInformal caregivers of patients with major LARS |
| Healthcare professionals | – | Behavioral: interviewsHealthcare professionals taking care for patients with LARS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be patients with major LARS, their informal caregivers and healthcare professionals
Key inclusion criteria (2 listed)
- adult patients (18+)
- confronted with major low anterior resection syndrome after rectal cancer surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviewssemi-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. | Behavioural | Healthcare professionals, Informal caregivers, Patients |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Derived from this study: PubMed 35253296Pape 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Anterior Resection Syndrome and Rectal Cancer, run by University Hospital, Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
needs and experiences of patients with major lars and their informal caregiver through individual semistructered interviews (time frame: Interview will last about 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04896879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.