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| Name | Class |
|---|---|
| AFP Innovation Fund | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | Obtaining 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video platform | Other | Participants in the intervention arm will obtain access to the video platform and have the surgical consultation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karineh Kazazian, MD PhD | University Health Network, Toronto | Principal Investigator |
| Sami A Chadi, MD MSc | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Toronto | Canada |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D017060 | Patient Satisfaction |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |