A Web-Based Person-Centred Navigation Tool for Newly Diagnosed Colorectal Cancer Patients: A Randomized Clinical Trial (RCT) to Assess Effects on Empowerment and Cost-Effectiveness (The TEN-C Study: Together to Enhance Navigation in Cancer)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 4
- 主要终点
- Empowerment
研究概览
简要总结
For individuals diagnosed with colorectal cancer, exposure to up-to-date cancer information and support as well as guidance to access the most appropriate health care services is crucial for cancer self-management and support. Timely access to high quality cancer information is suggested to contribute to patient empowerment - defined as the perception of being better able to manage illness demands. With the advent of the information age, individuals are increasingly turning to online health information resources. The use of rigorous web-based tools is found to be an engaging and convenient way to access health information, while being tailored to people's needs and preferences. The present study seeks to examine the effects of a recently developed high quality and person-centred web-based tool, the Oncology Interactive Navigator (OIN) on patients' empowerment as well as document its cost-effectiveness. Participants newly diagnosed with colorectal cancer will be randomly assigned to experimental or control groups with the former having unrestricted access to the OIN for 8 months. Participants in the control group will receive care as usual. Information on background, medical characteristics, and empowerment will be collected as well as cost-effectiveness indicators. If producing the desired effects, the OIN could be proposed for national implementation across Canadian cancer centers. Work is currently underway to add over 23 types of cancer diagnosis to the OIN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •histologically confirmed, first diagnosis of colorectal cancer (all stages)
- •within 20 weeks of when the individual was told s/he has colorectal cancer
- •fluent in English or French; able and willing to complete questionnaires
- •unrestricted home Internet access
- •has used the Internet at least once in the past
- •informed consent
排除标准
- •previous history of CRC at any time, or any other cancer diagnosed within the last 5 years (exception: superficial skin cancer)
- •medical or severe health problem
- •terminal phase of colorectal cancer or too sick to participate
研究组 & 干预措施
Routine Care
Participants who are randomized to the active comparator arm will receive routine care, which is the care routinely provided to the participant's patient population at the study centre.
干预措施: Routine Care (Other)
Routine Care plus OIN
OIN (Oncology Interactive Navigator) is the intervention. Participants who are randomized to routine care plus OIN will receive routine care and have unlimited access to the website for the study duration.
干预措施: Oncology Interactive Navigator (Other)
结局指标
主要结局
Empowerment
时间窗: 8 months
The main outcome for this trial is empowerment which is multidimensional. Key dimensions of empowerment are measured using five constructs from the health education impact Questionnaire system (reference). Repeated measures using analysis of variance will be used to compare patterns of change in empowerment constructs across time between trial groups. Reference: Osborne RH et al. Patient Educ Couns. 2007;66:192-201.
次要结局
- Cost-effectiveness(8 months)
研究者
Carmen G. Loiselle, N., Ph.D.
Associate Professor, Christine and Herschel Victor / Hope & Cope Chair in Psychosocial Oncology
McGill University
