Clinical trial NCT04713007: Improving Quality of Life for Colon Cancer Patients and Their Caregivers
Official title: Improving Quality of Life for Colon Cancer Patients and Their Caregivers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colon Cancer
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Alliance for Clinical Trials in Oncology
First posted: 2021-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life Scores
timeFrame: change from baseline to 3 months
measure: Quality of Life Scores
timeFrame: change from baseline to 3 months
measure: Perception of Care Coordination Participant
timeFrame: change from baseline to 3 months
measure: Perception of Care Coordination Caregiver
timeFrame: change from baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Pacific Health
state: Hawaii
city: Honolulu
country: United States
facility: The Queens Medical Center
state: Hawaii
city: Kailua
country: United States
facility: Adventist Health Castle
state: Hawaii
Study officials:
affiliation: University of Hawaii Cancer Research Center
name: Kevin D Cassel, Dr. PH
role: PRINCIPAL_INVESTIGATOR
References: