Colorectal CancerGUIDENCT07686133
Digital Education in Colorectal Cancer Patients
A study testing Video platform in people with Colorectal Cancer and Patient Satisfaction, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The goal of this clinical trial is to evaluate the impact of integrating video- based education in colorectal cancer surgery, with a specific focus on patient's perspective. The main questions it aims to answer are: Does addition of video-based patient education material lower patient's anxiety around colorectal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Patient Satisfaction, Patient Engagement
- What is being tested?
- Video platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 10 Mar 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adult patients (≥18 years of age).
- Biopsy-proven adenocarcinoma of the colon or rectum.
- Evaluated for surgical resection at the University Health Network (UHN).
- Undergoing elective, curative-intent: Right hemicolectomy, Left hemicolectomy, Sigmoid resection, Low anterior resection, Abdominoperineal resection
Who cannot join
- Age <18 years.
- Emergency surgery.
- Palliative surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Guiding Anxiety Reduction, Disease Understanding and Insightful Decision-Making Through Digital Education in Colorectal Cancer Patients, A Randomized Clinical Trial
The goal of this clinical trial is to evaluate the impact of integrating video- based education in colorectal cancer surgery, with a specific focus on patient's perspective. The main questions it aims to answer are:
Does addition of video-based patient education material lower patient's anxiety around colorectal cancer surgery? Does it increase patient's understanding of their diagnosis? Does it enhance patient's sense of shared decision-making? Researchers will compare an addition of video-based education to a standard surgical consultation to see if video improves patient's experience with colorectal cancer surgery.
Participants will be randomized at the time of referral. Intervention group will view the video prior to the surgical consultation. They will complete the survey at the end of the surgical consultation.
Read the detailed description
The objective of the proposed study is to evaluate the impact of integrating video- based education in colorectal cancer surgery, with a specific focus on patient's disease comprehension, and the enhancement of shared decision-making and patient-surgeon relationship. The investigators hypothesize that exposure to video-based education in addition to surgical consultation improves patient's understanding of colorectal cancer diagnosis and proposed surgical plan, which in turn empowers patients to become more involved in shared decision-making and be satisfied with their surgical care.
Primary objective of this study is to measure the impact of video-based education in colorectal surgery patients' shared decisional satisfaction and knowledge.
Secondary objective of this study is to assess the impact of video-based education in colorectal surgery patients on patients' satisfaction with care and levels of affective distress/anxiety.
The primary endpoint is completion of survey containing Questionnaire on Distress in Cancer Patients-Short Form (QSC-R10), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire INFO 25 (EORTC-QLQ- INFO25), Patient-Doctor Relationship Questionnaire (PDRQ-9), and 9-item Shared Decision Making Questionnaire (SDM-Q-9) at the time of clinic appointment.
Adult patients with biopsy-proven adenocarcinoma of the colon or rectum who are considered for surgical resection at the University Health Network (UHN) between November 2023 - October 2024 will be evaluated for inclusion. Patients who undergo elective, curative-intent right hemicolectomy, left-hemicolectomy, sigmoid resection, low anterior resection or abdominoperineal resection for colorectal cancer will be included.
Patients will be identified from outpatient GI surgical oncology and colorectal oncology clinics at the Princess Margaret Cancer Centre and Toronto General Hospital, UHN by the treating surgeons and surgical residents at the time of surgical discussion.
The research study nurse, research coordinator or research resident will consent eligible patients. The research coordinator will be responsible for randomizing patients 1:1 using the a priori computer-generated block randomized list to receive either the intervention (obtaining access to the video platform + surgical consultation) or be placed in the control arm (surgical consultation only, with an option to gain access to videos upon completion of the outcome survey). Treating personnel will be masked to which group patients are allocated to.
The research study nurse/research coordinator or research resident will assist patients in accessing the video education platform using iPads, which have been purchased for delivery of these videos and for patients to access REDCap to complete the outcome survey. They will guide them to the surgery-specific video (i.e. the right hemicolectomy video for patients with cancer in the right colon). After watching the video, patients in the intervention group will have their surgical consultation. The control group will receive only the surgical consultation before completing the outcome survey.
Patients in the control group will have the option to view the videos after the survey to ensure ethical and equal access to educational resources. Those who watch the videos will have the option to complete a second outcome survey.
Descriptive statistics will be used to detail the demographic characteristics of the study population using t tests for linear variables and Fisher exact tests for categorical variables. Continuous data will be reported as means with standard deviations, and categorical data will be reported as percentages. Mean and standard deviation will be used to calculate the intervention effect using individual t-tests. Cohen d will be used as an effect size measure of the difference between intervention versus control groups with d=0.2 considered small, d=0.5 medium, and d=0.8 large effect. Multivariate analysis will be performed to test whether certain demographic characteristics increase risk for patient dissatisfaction. Statistical significance is considered as p<0.05. All statistical analyses will be conducted using SAS Version 9.3 or R version 4.2.2.
- Conditions
- Colorectal Cancer, Patient Satisfaction, Patient Engagement, Patient
- Being tested
- Video platform
- Keywords
- Video-based education
- Medical subject headings
- Colorectal Neoplasms, Patient Satisfaction, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video platformOther
Participants in the intervention arm will obtain access to the video platform and have the surgical consultation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Obtaining access to the video platform and surgical consultation Receives: Other: Video platform |
| Control | No intervention | Surgical consultation only, with an option to gain access to videos upon completion of the outcome survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety related to colorectal cancer surgery
Assessed using the Questionnaire on Stress in Cancer Patients-Revised (QSC-R10), a 10-item, 5-point Likert scale. Scores range from 0 to 50, with higher scores indicating greater cancer-related distress.
Measured: Baseline
Disease-related information received
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Information Module (EORTC QLQ-INFO25). Scores are transformed to a 0-100 scale, with higher scores indicating better perceived information received.
Measured: Baseline
Physician-patient relationship
Assessed using the Patient-Doctor Relationship Questionnaire (PDRQ-9), a 9-item, 5-point Likert scale. Scores range from 9 to 45, with higher scores indicating a better physician-patient relationship.
Measured: Baseline
Shared decision-making
Assessed using the 9-item Shared Decision-Making Questionnaire (SDM-Q-9). Scores range from 0 to 45, with higher scores indicating greater shared decision-making.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start10 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionOct 2027 (estimated)
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 University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- AFP Innovation Fund
- Responsible party
- Principal investigator, Karineh Kazazian, University Health Network, Toronto
- Investigators
- Karineh Kazazian, MD PhD, Principal investigator, University Health Network, TorontoSami A Chadi, MD MSc, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686133
- Sponsor's protocol ID
- 24-5230
- Acronym
- GUIDE
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guiding Anxiety Reduction, Disease Understanding and Insightful Decision-Making Through Digital Education in Colorectal Cancer Patients, A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07686133
- Acronym / sponsor ID
- GUIDE / 24-5230
- Conditions
- Colorectal Cancer, Patient Satisfaction, Patient Engagement, Patient
- Keywords
- Video-based education
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- AFP Innovation Fund
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 7 Jul 2026 (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 goal of this clinical trial is to evaluate the impact of integrating video- based education in colorectal cancer surgery, with a specific focus on patient's perspective. The main questions it aims to answer are:
Does addition of video-based patient education material lower patient's anxiety around colorectal cancer surgery? Does it increase patient's understanding of their diagnosis? Does it enhance patient's sense of shared decision-making? Researchers will compare an addition of video-based education to a standard surgical consultation to see if video improves patient's experience with colorectal cancer surgery.
Participants will be randomized at the time of referral. Intervention group will view the video prior to the surgical consultation. They will complete the survey at the end of the surgical consultation.
Detailed description
The objective of the proposed study is to evaluate the impact of integrating video- based education in colorectal cancer surgery, with a specific focus on patient's disease comprehension, and the enhancement of shared decision-making and patient-surgeon relationship. The investigators hypothesize that exposure to video-based education in addition to surgical consultation improves patient's understanding of colorectal cancer diagnosis and proposed surgical plan, which in turn empowers patients to become more involved in shared decision-making and be satisfied with their surgical care.
Primary objective of this study is to measure the impact of video-based education in colorectal surgery patients' shared decisional satisfaction and knowledge.
Secondary objective of this study is to assess the impact of video-based education in colorectal surgery patients on patients' satisfaction with care and levels of affective distress/anxiety.
The primary endpoint is completion of survey containing Questionnaire on Distress in Cancer Patients-Short Form (QSC-R10), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire INFO 25 (EORTC-QLQ- INFO25), Patient-Doctor Relationship Questionnaire (PDRQ-9), and 9-item Shared Decision Making Questionnaire (SDM-Q-9) at the time of clinic appointment.
Adult patients with biopsy-proven adenocarcinoma of the colon or rectum who are considered for surgical resection at the University Health Network (UHN) between November 2023 - October 2024 will be evaluated for inclusion. Patients who undergo elective, curative-intent right hemicolectomy, left-hemicolectomy, sigmoid resection, low anterior resection or abdominoperineal resection for colorectal cancer will be included.
Patients will be identified from outpatient GI surgical oncology and colorectal oncology clinics at the Princess Margaret Cancer Centre and Toronto General Hospital, UHN by the treating surgeons and surgical residents at the time of surgical discussion.
The research study nurse, research coordinator or research resident will consent eligible patients. The research coordinator will be responsible for randomizing patients 1:1 using the a priori computer-generated block randomized list to receive either the intervention (obtaining access to the video platform + surgical consultation) or be placed in the control arm (surgical consultation only, with an option to gain access to videos upon completion of the outcome survey). Treating personnel will be masked to which group patients are allocated to.
The research study nurse/research coordinator or research resident will assist patients in accessing the video education platform using iPads, which have been purchased for delivery of these videos and for patients to access REDCap to complete the outcome survey. They will guide them to the surgery-specific video (i.e. the right hemicolectomy video for patients with cancer in the right colon). After watching the video, patients in the intervention group will have their surgical consultation. The control group will receive only the surgical consultation before completing the outcome survey.
Patients in the control group will have the option to view the videos after the survey to ensure ethical and equal access to educational resources. Those who watch the videos will have the option to complete a second outcome survey.
Descriptive statistics will be used to detail the demographic characteristics of the study population using t tests for linear variables and Fisher exact tests for categorical variables. Continuous data will be reported as means with standard deviations, and categorical data will be reported as percentages. Mean and standard deviation will be used to calculate the intervention effect using individual t-tests. Cohen d will be used as an effect size measure of the difference between intervention versus control groups with d=0.2 considered small, d=0.5 medium, and d=0.8 large effect. Multivariate analysis will be performed to test whether certain demographic characteristics increase risk for patient dissatisfaction. Statistical significance is considered as p<0.05. All statistical analyses will be conducted using SAS Version 9.3 or R version 4.2.2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Video platformObtaining access to the video platform and surgical consultation |
| Control | No intervention | –Surgical consultation only, with an option to gain access to videos upon completion of the outcome survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥18 years of age).
- Biopsy-proven adenocarcinoma of the colon or rectum.
- Evaluated for surgical resection at the University Health Network (UHN).
- Undergoing elective, curative-intent: Right hemicolectomy, Left hemicolectomy, Sigmoid resection, Low anterior resection, Abdominoperineal resection
Key exclusion criteria (3 listed)
- Age <18 years.
- Emergency surgery.
- Palliative surgery.
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 platformParticipants in the intervention arm will obtain access to the video platform and have the surgical consultation. | Other | Intervention |
Primary outcome
Anxiety related to colorectal cancer surgery
Time frame: Baseline
Assessed using the Questionnaire on Stress in Cancer Patients-Revised (QSC-R10), a 10-item, 5-point Likert scale. Scores range from 0 to 50, with higher scores indicating greater cancer-related distress.
Disease-related information received
Time frame: Baseline
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Information Module (EORTC QLQ-INFO25). Scores are transformed to a 0-100 scale, with higher scores indicating better perceived information received.
Physician-patient relationship
Time frame: Baseline
Assessed using the Patient-Doctor Relationship Questionnaire (PDRQ-9), a 9-item, 5-point Likert scale. Scores range from 9 to 45, with higher scores indicating a better physician-patient relationship.
Shared decision-making
Time frame: Baseline
Assessed using the 9-item Shared Decision-Making Questionnaire (SDM-Q-9). Scores range from 0 to 45, with higher scores indicating greater shared decision-making.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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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.
Karineh Kazazian, MD PhD principal investigator
University Health Network, Toronto
Sami A Chadi, MD MSc principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video platform in people with Colorectal Cancer and Patient Satisfaction, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 7 Jul 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Anxiety related to colorectal cancer surgery (time frame: Baseline). The study lists 4 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 7 Jul 2026.