Improving Quality of Life for Colon Cancer Patients and Their Caregivers

Sponsor
University of Hawaii (Other)
Overall Status
Recruiting
CT.gov ID
NCT04713007
Collaborator
Alliance for Clinical Trials in Oncology (Other)
120
4
2
56
30
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Quality of Life Ted Talks
  • Behavioral: Quality of Life Supportive Resources
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Improving Quality of Life for Colon Cancer Patients and Their Caregivers
Actual Study Start Date :
Jun 3, 2021
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Quality of Life Scores [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hawaii Cancer Care Inc Honolulu Hawaii United States 96813
2 Hawaii Pacific Health Honolulu Hawaii United States 96813
3 The Queens Medical Center Honolulu Hawaii United States 96813
4 Adventist Health Castle Kailua Hawaii United States 96734

Sponsors and Collaborators

  • University of Hawaii
  • Alliance for Clinical Trials in Oncology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Hawaii
ClinicalTrials.gov Identifier:
NCT04713007
Other Study ID Numbers:
  • Cassel 2020-2
First Posted:
Jan 19, 2021
Last Update Posted:
Jun 28, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2021