Colon CancerNCT04713007
Improving Quality of Life for Colon Cancer Patients and Their Caregivers
A study testing Quality of Life Ted Talks and Quality of Life Supportive Resources in people with Colon Cancer, run by University of Hawaii at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Quality of Life Ted Talks and Quality of Life Supportive Resources
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Jun 2021to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- -Patients who are > 60 days from surgical treatment will be ineligible
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hawaii Cancer Care Inc
Honolulu, Hawaii, 96813
Hawaii Pacific Health
Honolulu, Hawaii, 96813
The Queens Medical Center
Honolulu, Hawaii, 96813
Adventist Health Castle
Kailua, Hawaii, 96734
About this study
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
- Being tested
- Quality of Life Ted Talks, Quality of Life Supportive Resources
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life Ted TalksBehavioural
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 ResourcesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Supportive Care Materials and Resources Receives: Behavioral: Quality of Life Supportive Resources |
| Group A | Experimental | Ted Talks/Educational videos Receives: Behavioral: Quality of Life Ted Talks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scores
Compare QOL scores of patients using the EORTC QLQ-C30 instrument at post randomization between intervention and control arm
Measured: 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
Measured: 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
Measured: 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
Measured: change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start3 Jun 2021
- Primary completion31 Mar 2025
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Clinical Trials in Oncology
- Responsible party
- Sponsor
- Investigators
- Kevin D Cassel, Dr. PH, Principal investigator, University of Hawaii Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713007
- Sponsor's protocol ID
- Cassel 2020-2
- Status last verified
- Apr 2025
- First submitted
- 29 Dec 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life for Colon Cancer Patients and Their Caregivers
- ClinicalTrials.gov ID
- NCT04713007
- Acronym / sponsor ID
- Cassel 2020-2
- Conditions
- Colon Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Alliance for Clinical Trials in Oncology
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Quality of Life Supportive ResourcesSupportive Care Materials and Resources |
| Group A | Experimental | Behavioral: Quality of Life Ted TalksTed Talks/Educational videos |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- -Patients who are > 60 days from surgical treatment will be ineligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of Life Ted TalksThere 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. | Behavioural | Group A |
| Quality of Life Supportive ResourcesThe 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. | Behavioural | Group 1 |
Primary outcome
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin D Cassel, Dr. PH principal investigator
University of Hawaii Cancer Research Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life Ted Talks and Quality of Life Supportive Resources in people with Colon Cancer, run by University of Hawaii at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Scores (time frame: change from baseline to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.