跳至主要内容
临床试验/NCT04713007
NCT04713007进行中(未招募)不适用

Improving Quality of Life for Colon Cancer Patients and Their Caregivers

University of Hawaii8 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
8
主要终点
Perception of Care Coordination Participant

研究概览

简要总结

By joining this study, participants, including patients and their caregivers, will be provided useful information about colon cancer that may help alleviate anxiety surrounding treatment, improve communications with the medical team, and identify practical ways to support each other. Participating in this study will have no impact on your cancer care that participants receive from your provider. It is expected that the resources provided to participants and participants caregiver will help improve participants overall care. The study team will provide computer tablets for patients and their caregivers to use as part of the study to access information about colon cancer and how to help manage participants therapeutic care. The study team will check-in each week to provide assistance with the use of the tablets and ask the patient and their caregiver, to complete an assessment survey.

As part of the surveys the study team will collect participants full name, address and phone number and some basic information about participants (e.g., age, gender and race). The study team will also collect some personal or medical information, including the stage of colon cancer and treatment received (if the participant) or your relationship to the patient if participants caregiver. The study team will also collect some information on your emotional health and views about the medical care that has been provided to date from the questionnaire. All this information will be held confidential and not forwarded to anyone outside of the study personnel. There are no activities required, except that the study team will encourage caregivers and patients to discuss and use the information provided in computer tablets to enhance their cancer care. Whether or not the participants use this information will not affect their ability to receive high-quality care from their providers.

There is a slight burden of responding to the survey questions used to help us understand the useful features of this program. For this reason, the investigator has included small incentives to support the time and effort needed to complete these survey assessments. The study team hopes that this study, one of the first of its kind, will help identify the resources and methods that can be used to help patients and caregivers have a better understanding of their cancer care and provide resources that they can use to enhance the effectiveness of their therapy.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colon Cancer patients must live in Honolulu County and must identify a patient caregiver
  • Patients must have newly diagnosed stage II-III colon cancer and be < 60 days from surgical treatment at the time of registration.
  • Adults over age 18
  • Adequate understanding of English language and must be able to read and write English
  • Must be able to provide informed consent

排除标准

  • Patients who are > 60 days from surgical treatment will be ineligible
  • Inclusion Criteria: Caregiver
  • Must live in Honolulu County
  • Must either be an adult family member of a colon cancer patient or a patient identified caregiver
  • Adults over age 18
  • Adequate understanding of English language and must be able to read and write English
  • Must be able to provide informed consent

结局指标

主要结局

Perception of Care Coordination Participant

时间窗: change from baseline to 3 months

Care coordination will be measured using our developed care coordination instruments (CCI), a 29 item, self-reported, multiple choice survey questionnaire

Perception of Care Coordination Caregiver

时间窗: change from baseline to 3 months

Care coordination will be measured using our developed care coordination instruments (CCICG), a 29 item, self-reported, multiple choice survey questionnaire

Quality of Life Scores

时间窗: change from baseline to 3 months

Compare QOL scores of patients using the EORTC QLQ-C30 instrument at post randomization between intervention and control arm

次要结局

未报告次要终点

研究者

发起方
University of Hawaii
申办方类型
Other
责任方
Sponsor

研究点 (8)

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