跳至主要内容
临床试验/NCT01549327
NCT01549327已完成不适用

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)

McGill University4 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2012年5月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmen G. Loiselle, N., Ph.D.

Associate Professor, Christine and Herschel Victor / Hope & Cope Chair in Psychosocial Oncology

McGill University

研究点 (4)

Loading locations...

相似试验

已完成
不适用
Using Whole-Person-Care Guide in Patients Receiving Care for Cancer or Complications From Cancer TreatmentInfectionThrombocytopeniaRadiation ToxicityMalnutritionMusculoskeletal ComplicationsNeutropeniaUnspecified Adult Solid Tumor, Protocol SpecificChemotherapeutic Agent Toxicity
NCT00608738Northwestern University750
已完成
不适用
Patient Portal and Navigation Program in Providing Information for Asian American Cancer PatientsStage I Colorectal Cancer AJCC v8Stage IA2 Lung Cancer AJCC v8Stage IIA Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Liver CancerCaregiverStage II Colorectal Cancer AJCC v8Stage IIB Lung Cancer AJCC v8Stage III Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Malignant NeoplasmPhysicianStage I Liver CancerStage IA3 Lung Cancer AJCC v8Stage II Liver CancerStage II Lung Cancer AJCC v8Stage IIA Lung Cancer AJCC v8Stage IIB Colorectal Cancer AJCC v8Stage IIC Colorectal Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage I Lung Cancer AJCC v8Stage IA1 Lung Cancer AJCC v8Stage IB Lung Cancer AJCC v8
NCT03867916University of California, San Francisco106
已完成
不适用
Extra Layer Of SupportAdvanced CancerPalliative Care
NCT03532997Duke University151
已完成
3 期
Increasing Colorectal Cancer Screening Uptake With a Patient NavigatorColorectal Cancer
NCT01506687Cancer Care Ontario750
已完成
不适用
Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use DisorderColoRectal Cancer Screening
NCT03244787Massachusetts General Hospital380