Improving Quality of Life for Colon Cancer Patients and Their Caregivers

NCT04713007 | Active Not Recruiting

• 1 other identifier: Cassel 2020-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

Supportive Care Materials and Resources

Behavioral: Quality of Life Supportive Resources

Group A

EXPERIMENTAL

Ted Talks/Educational videos

Behavioral: Quality of Life Ted Talks

Interventions

Quality of Life Ted Talks 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.

Group A

Quality of Life Supportive Resources 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 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Hawaii: lead
• Alliance for Clinical Trials in Oncology: collaborator

Study Sites (4)

Hawaii Cancer Care Inc

Honolulu, Hawaii, 96813, United States

Location

Hawaii Pacific Health

Honolulu, Hawaii, 96813, United States

Location

The Queens Medical Center

Honolulu, Hawaii, 96813, United States

Location

Adventist Health Castle

Kailua, Hawaii, 96734, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Kevin D Cassel, Dr. PH

  University of Hawaii Cancer Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 19, 2021
• Study Start: June 3, 2021
• Primary Completion: March 31, 2025
• Study Completion: February 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)