Improving Quality of Life for Colon Cancer Patients and Their Caregivers

Study Overview
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Brief Summary
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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.

Official Title
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Improving Quality of Life for Colon Cancer Patients and Their Caregivers

Conditions
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Colon Cancer

Intervention / Treatment
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* Behavioral: Quality of Life Ted Talks
* Behavioral: Quality of Life Supportive Resources


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 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 Exclusion Criteria: Patient -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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Supportive Care Materials and Resources | Behavioral: Quality of Life Supportive Resources<br>* The tablet will be preloaded with cancer information and supportive care resources from the National Cancer Institute. A survey will be required at baseline, each of the 9 weeks and at 3 months.<br>|
| Experimental: Group A<br>Ted Talks/Educational videos | Behavioral: Quality of Life Ted Talks<br>* There will be 9 training modules released weekly on the tablet. A survey will be required at baseline, each of the 9 weeks and at 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Scores | Compare QOL scores of patients using the EORTC QLQ-C30 instrument at post randomization between intervention and control arm | change from baseline to 3 months | 
| Quality of Life Scores | Compare QOL scores of caregivers using the CQOLC instrument at post randomization between intervention and control arm | change from baseline to 3 months | 
| Perception of Care Coordination Participant | Care coordination will be measured using our developed care coordination instruments (CCI), a 29 item, self-reported, multiple choice survey questionnaire | change from baseline to 3 months | 
| Perception of Care Coordination Caregiver | Care coordination will be measured using our developed care coordination instruments (CCICG), a 29 item, self-reported, multiple choice survey questionnaire | change from baseline to 3 months |