Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04713007

Improving Quality of Life for Colon Cancer Patients and Their Caregivers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hawaii Cancer Care Inc, Honolulu, Hawaii, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • Alliance for Clinical Trials in Oncology

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 19, 2021
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.