Guiding Anxiety Reduction, Disease Understanding and Insightful Decision-Making Through Digital Education in Colorectal Cancer Patients, A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Anxiety related to colorectal cancer surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age <18 years.
- •Emergency surgery.
- •Palliative surgery.
结局指标
主要结局
Anxiety related to colorectal cancer surgery
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Karineh Kazazian
Principal Investigator
University Health Network, Toronto