Low Anterior Resection SyndromeNCT04938336
Evaluation of a Decision Aid Tool in Rectal Cancer patiënts
An observational study of Low Anterior Resection Syndrome and Rectal Cancer, run by University Hospital, Ghent at 2 sites in Belgium.
Trial 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 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?
- Delphi Procedure and interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 2 sitesBelgium
- Study dates
- 22 Apr 2022to 10 Jul 2024
- 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
- Adult, Older adult
Study population: patients with rectal cancer healthcare professionals caring for patients with rectal cancer informal carers of patients with rectal cancer
Who may be able to join
- expert healthcare professionals caring for patients with rectal cancer
Who cannot join
- none
- Interviews Inclusion criteria
- 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
- informal carer indicated by the patient Exclusion
- patients who have no treatment choice due to oncological reasons
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University hospital Ghent
Ghent, Oost-Vlaanderen, 9000
University Hospital Ghent
Ghent, 9000
About this study
Adapt and evaluate a decision aid for patients with rectal cancer. Phase 1 : decision aid testing (Delphi) multicentric Phase 2: pilot test decision aid
Read the detailed description
Adapt and evaluate a decision aid for patients with rectal cancer. Phase1: decision aid testing (Delphi) A pilot version of the Belgian decision aid was developed and validated through a double Delphi procedure. In this study, the assessment is extended to several multicentre experts. The panel consists of ten experts who have extensive knowledge in the field of rectal cancer or scientific research. They are asked to evaluate the information and questions on accuracy, clarity, readability and relevance. They score the items of the decision aid using a 4-point Likert-type scale (one (one = totally irrelevant; four = very relevant) and a dichotomous scale (one = clear, two = not clear) to assess relevance and clarity of wording, respectively (see Appendix 2 to this application). To quantify the degree of content validity, the Content Validity Index (CVI) is used.
Phase2: pilot test decision aid The final step of the study is a pilot test of the decision aid with patients who will undergo surgery/watch and wait strategy in the near future and with healthcare professionals who work with the decision aid. The aim is to test the acceptability of the decision aid with the patient and the ease of use with the healthcare professional. With the feedback from the patients and the healthcare professional, the decision aid can be further refined.
During the consultation in which the intervention is discussed, the consent to participate will be asked of the patient and also of the informal carer who may be present at that moment. Participation in the study means that during this consultation, the caregiver involved will go through the decision aid completely with the patient and any informal carer. After the intervention, they will be asked to give feedback on their experiences with the use of the decision aid. This will be done by means of an interview for the patients, informal carers and care workers involved. The interview with the patient (and informal carer if applicable) will take place at home or in the hospital, depending on their preference. The interview with the caregiver takes place in the hospital where the caregiver works. If the current Covid-19 pandemic does not allow for a visit to the patient's home or to another hospital, the interviews will be conducted by telephone or video call.
- Conditions
- Low Anterior Resection Syndrome, Rectal Cancer
- Being tested
- Delphi Procedure and 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.
Delphi Procedure and interviewsBehavioural
Delphi procedure with expert healthcare professionals and interviews with patients, healthcare professionals and informal carers
| Study group | Role | What they receive |
|---|---|---|
| expert healthcare professionals | Delphi Procedure Receives: Behavioral: Delphi Procedure and interviews | |
| healthcare professionals, patients and informal carers | interviews Receives: Behavioral: Delphi Procedure and interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of accuracy of the decision aid tool trough a delphi procedure
Assessment of accuracy of the decision aid tool through a delphi procedure
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 posted24 Jun 2021
- Study start22 Apr 2022
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Sint-Lucas Gent, AZ Sint-Jan AV, AZ Delta, Kom Op Tegen Kanker
- Responsible party
- Sponsor
- Investigators
- Piet Pattyn, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938336
- Sponsor's protocol ID
- BC-10030
- Status last verified
- Jul 2024
- First submitted
- 1 Jun 2021
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Decision Aid Tool in Rectal Cancer patiënts
- ClinicalTrials.gov ID
- NCT04938336
- Acronym / sponsor ID
- BC-10030
- Conditions
- Low Anterior Resection Syndrome, Rectal Cancer
- Keywords
- low anterior resection syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- AZ Sint-Lucas Gent, AZ Sint-Jan AV, AZ Delta, Kom Op Tegen Kanker
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 24 Jun 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.
Adapt and evaluate a decision aid for patients with rectal cancer. Phase 1 : decision aid testing (Delphi) multicentric Phase 2: pilot test decision aid
Detailed description
Adapt and evaluate a decision aid for patients with rectal cancer. Phase1: decision aid testing (Delphi) A pilot version of the Belgian decision aid was developed and validated through a double Delphi procedure. In this study, the assessment is extended to several multicentre experts. The panel consists of ten experts who have extensive knowledge in the field of rectal cancer or scientific research. They are asked to evaluate the information and questions on accuracy, clarity, readability and relevance. They score the items of the decision aid using a 4-point Likert-type scale (one (one = totally irrelevant; four = very relevant) and a dichotomous scale (one = clear, two = not clear) to assess relevance and clarity of wording, respectively (see Appendix 2 to this application). To quantify the degree of content validity, the Content Validity Index (CVI) is used.
Phase2: pilot test decision aid The final step of the study is a pilot test of the decision aid with patients who will undergo surgery/watch and wait strategy in the near future and with healthcare professionals who work with the decision aid. The aim is to test the acceptability of the decision aid with the patient and the ease of use with the healthcare professional. With the feedback from the patients and the healthcare professional, the decision aid can be further refined.
During the consultation in which the intervention is discussed, the consent to participate will be asked of the patient and also of the informal carer who may be present at that moment. Participation in the study means that during this consultation, the caregiver involved will go through the decision aid completely with the patient and any informal carer. After the intervention, they will be asked to give feedback on their experiences with the use of the decision aid. This will be done by means of an interview for the patients, informal carers and care workers involved. The interview with the patient (and informal carer if applicable) will take place at home or in the hospital, depending on their preference. The interview with the caregiver takes place in the hospital where the caregiver works. If the current Covid-19 pandemic does not allow for a visit to the patient's home or to another hospital, the interviews will be conducted by telephone or video call.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| expert healthcare professionals | – | Behavioral: Delphi Procedure and interviewsDelphi Procedure |
| healthcare professionals, patients and informal carers | – | Behavioral: Delphi Procedure and interviewsinterviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with rectal cancer healthcare professionals caring for patients with rectal cancer informal carers of patients with rectal cancer
Key inclusion criteria (1 listed)
- expert healthcare professionals caring for patients with rectal cancer
Key exclusion criteria (7 listed)
- none
- Interviews Inclusion criteria
- 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
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 |
|---|---|---|
| Delphi Procedure and interviewsDelphi procedure with expert healthcare professionals and interviews with patients, healthcare professionals and informal carers | Behavioural | expert healthcare professionals, healthcare professionals, patients and informal carers |
Primary outcome
Assessment of accuracy of the decision aid tool trough a delphi procedure
Time frame: 2-3 months (until consensus)
Assessment of accuracy of the decision aid tool through a delphi procedure
Assessment of clarity of the decision aid tool trough a delphi procedure
Time frame: 2-3 months (until consensus)
Assessment of clarity of the decision aid tool trough a delphi procedure
Assessment of relevance of the decision aid tool trough a delphi procedure
Time frame: 2-3 months (until consensus)
Assessment of relevance of the decision aid tool trough a delphi procedure
Assessment of readability of the decision aid tool trough a delphi procedure
Time frame: 2-3 months (until consensus)
Assessment of readability of the decision aid tool trough a delphi procedure
Assessment of the acceptability of the decision aid tool through individual interview
Time frame: about 60 minutes
Assessment of the acceptability of the decision aid tool through individual interview
Assessment of the usability of the decision aid tool through individual interviews
Time frame: about 60 minutes
Assessment of the usability of the decision aid tool through individual interviews
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 11 Jul 2024.
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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.
Piet Pattyn principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
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 at 2 sites in Belgium.
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 1 inclusion and 7 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 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Assessment of accuracy of the decision aid tool trough a delphi procedure (time frame: 2-3 months (until consensus)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2024.