Improving Quality of Life for Colon Cancer Patients and Their Caregivers

NCT ID: NCT04713007

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2026-02-28

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group 1

Supportive Care Materials and Resources

Group Type: EXPERIMENTAL

Quality of Life Supportive Resources

Intervention Type: BEHAVIORAL

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.

Group A

Ted Talks/Educational videos

Group Type: EXPERIMENTAL

Quality of Life Ted Talks

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

Exclusion Criteria

-Patients who are > 60 days from surgical treatment will be ineligible

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin D Cassel, Dr. PH

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii Cancer Research Center

Locations

Hawaii Cancer Care Inc

Honolulu, Hawaii, United States

Hawaii Pacific Health

Honolulu, Hawaii, United States

The Queens Medical Center

Honolulu, Hawaii, United States

Adventist Health Castle

Kailua, Hawaii, United States

Countries

United States

Other Identifiers

Cassel 2020-2

Identifier Type: -

Identifier Source: org_study_id