Improving Quality of Life for Colon Cancer Patients and Their Caregivers

April 2, 2024 updated by: University of Hawaii

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
      • Honolulu, Hawaii, United States, 96813
      • Honolulu, Hawaii, United States, 96813
      • Kailua, Hawaii, United States, 96734

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Supportive Care Materials and Resources
Behavioral: Quality of Life Supportive Resources
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.
Experimental: Group A
Ted Talks/Educational videos
Behavioral: Quality of Life Ted Talks
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Scores
Time Frame: 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
change from baseline to 3 months
Quality of Life Scores
Time Frame: change from baseline to 3 months
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
Time Frame: 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
change from baseline to 3 months
Perception of Care Coordination Caregiver
Time Frame: 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
change from baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hawaii

Collaborators

Alliance for Clinical Trials in Oncology

Investigators

  • Principal Investigator: Kevin D Cassel, Dr. PH, University of Hawaii Cancer Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2021

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cassel 2020-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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