Improving Quality of Life for Colon Cancer Patients and Their Caregivers
Primary Purpose
Colon Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality of Life Ted Talks
Quality of Life Supportive Resources
Sponsored by
About this trial
This is an interventional supportive care trial for Colon Cancer
Eligibility Criteria
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
Sites / Locations
- Hawaii Cancer Care IncRecruiting
- Hawaii Pacific HealthRecruiting
- The Queens Medical CenterRecruiting
- Adventist Health CastleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group A
Arm Description
Supportive Care Materials and Resources
Ted Talks/Educational videos
Outcomes
Primary Outcome Measures
Quality of Life Scores
Compare QOL scores of patients using the EORTC QLQ-C30 instrument at post randomization between intervention and control arm
Quality of Life Scores
Compare QOL scores of caregivers using the CQOLC instrument at post randomization between intervention and control arm
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04713007
First Posted
December 29, 2020
Last Updated
October 18, 2023
Sponsor
University of Hawaii
Collaborators
Alliance for Clinical Trials in Oncology
1. Study Identification
Unique Protocol Identification Number
NCT04713007
Brief Title
Improving Quality of Life for Colon Cancer Patients and Their Caregivers
Official Title
Improving Quality of Life for Colon Cancer Patients and Their Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii
Collaborators
Alliance for Clinical Trials in Oncology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Supportive Care Materials and Resources
Arm Title
Group A
Arm Type
Experimental
Arm Description
Ted Talks/Educational videos
Intervention Type
Behavioral
Intervention Name(s)
Quality of Life Ted Talks
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Quality of Life Supportive Resources
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life Scores
Description
Compare QOL scores of patients using the EORTC QLQ-C30 instrument at post randomization between intervention and control arm
Time Frame
change from baseline to 3 months
Title
Quality of Life Scores
Description
Compare QOL scores of caregivers using the CQOLC instrument at post randomization between intervention and control arm
Time Frame
change from baseline to 3 months
Title
Perception of Care Coordination Participant
Description
Care coordination will be measured using our developed care coordination instruments (CCI), a 29 item, self-reported, multiple choice survey questionnaire
Time Frame
change from baseline to 3 months
Title
Perception of Care Coordination Caregiver
Description
Care coordination will be measured using our developed care coordination instruments (CCICG), a 29 item, self-reported, multiple choice survey questionnaire
Time Frame
change from baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Drucker, MS
Phone
808-564-3989
Email
IIT@cc.hawaii.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin D Cassel, Dr. PH
Organizational Affiliation
University of Hawaii Cancer Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawaii Cancer Care Inc
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Tamura
Email
david.tamura@hawaiicancercare.com
Facility Name
Hawaii Pacific Health
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randal Liu
Email
randall@straub.net
Facility Name
The Queens Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton Chong
Email
CChong@cc.hawaii.edu
Facility Name
Adventist Health Castle
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96734
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Loui
Email
wslouimd@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Improving Quality of Life for Colon Cancer Patients and Their Caregivers
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