Colorectal CancerNCT04538677
Video Consultation During Follow up Surgical Care
An observational study of Colorectal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The aim of this study was to compare the willingness to use and attitude towards VC amongst both patients with colorectal cancer and healthcare providers during follow up care. Second, to determine the satisfaction with the quality of the healthcare provider and the usability of the used VC technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Video consultation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2017to 23 Aug 2017
- 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: Patients with colorectal cancer scheduled for appointment at the surgical oncology outpatient a tertiary referral center.
Who may be able to join
- Age 18 years or older
- Fluent in speaking and writing in Dutch
- Follow up appointments in which overall progress, new complaints, results with good news and treatment was discussed were considered feasible.
Who cannot join
- Introductory appointments
- Bad news consultations
- Physical examination needed
- No access to Internet
- No access to a smartphone, tablet or computer with a camera
- Not willing to activate their electronic patient portal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video Consultation During Follow up Care: Effect on Quality of Care and Patient- and Provider Attitude in Patients With Colorectal Cancer
The aim of this study was to compare the willingness to use and attitude towards VC amongst both patients with colorectal cancer and healthcare providers during follow up care. Second, to determine the satisfaction with the quality of the healthcare provider and the usability of the used VC technology. 50 patients will be asked to choose between video consultation or face-to-face contact at the outpatient surgical clinic.
- Conditions
- Colorectal Cancer
- Being tested
- Video consultation
- Keywords
- Video Consultation, Virtual visits
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video consultationDevice
A two-way audio and visual connection between patients and surgeons
| Study group | Role | What they receive |
|---|---|---|
| F2F-Group | Patients who preferred a traditional F2F-appointment were seen at the outpatient clinic. | |
| VC-group | Patients who preferred a video consult were seen over a video connection. Receives: Device: Video consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitude and satisfaction with video consultation
PAT-VC questionnaire
Measured: Immediately after the consult
Secondary outcomes (3)
Usability of the video consultation technology
SUS questionnaire
Measured: Immediately after the test consult
Quality of provided care by surgeon: MSF questionnaire
MSF questionnaire
Measured: Immediately after the consult
Satisfaction of surgeons: Questionnaire
Questionnaire
Measured: Immediately after the consult
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Jun 2017
- Primary completion23 Aug 2017
- Study completion23 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. W.A. Bemelman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538677
- Sponsor's protocol ID
- W17_149
- Status last verified
- Aug 2020
- First submitted
- 31 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Consultation During Follow up Care: Effect on Quality of Care and Patient- and Provider Attitude in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04538677
- Acronym / sponsor ID
- W17_149
- Conditions
- Colorectal Cancer
- Keywords
- Video Consultation, Virtual visits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 23 Aug 2017 (actual)
- First posted
- 4 Sep 2020 (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.
The aim of this study was to compare the willingness to use and attitude towards VC amongst both patients with colorectal cancer and healthcare providers during follow up care. Second, to determine the satisfaction with the quality of the healthcare provider and the usability of the used VC technology. 50 patients will be asked to choose between video consultation or face-to-face contact at the outpatient surgical clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F2F-Group | – | –Patients who preferred a traditional F2F-appointment were seen at the outpatient clinic. |
| VC-group | – | Device: Video consultationPatients who preferred a video consult were seen over a video connection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancer scheduled for appointment at the surgical oncology outpatient a tertiary referral center.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Fluent in speaking and writing in Dutch
- Follow up appointments in which overall progress, new complaints, results with good news and treatment was discussed were considered feasible.
Key exclusion criteria (6 listed)
- Introductory appointments
- Bad news consultations
- Physical examination needed
- No access to Internet
- No access to a smartphone, tablet or computer with a camera
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 |
|---|---|---|
| Video consultationA two-way audio and visual connection between patients and surgeons | Device | VC-group |
Primary outcome
Attitude and satisfaction with video consultation
Time frame: Immediately after the consult
PAT-VC questionnaire
3 secondary outcomes
Usability of the video consultation technology
Time frame: Immediately after the test consult
Quality of provided care by surgeon: MSF questionnaire
Time frame: Immediately after the consult
Satisfaction of surgeons: Questionnaire
Time frame: Immediately after the consult
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 4 Sep 2020.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 3 inclusion and 6 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 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Attitude and satisfaction with video consultation (time frame: Immediately after the consult). 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 4 Sep 2020.