- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05162404
Video Education to Improve Rural Cancer Care Delivery
December 7, 2023 updated by: University of Hawaii
Patient-Centered Video Education Intervention to Improve Rural Cancer Care Delivery
The purpose of this study is to understand if a video-based education program delivered on a tablet device will improve care coordination experiences for patients with cancer living in rural areas.
Study Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
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Honolulu, Hawaii, United States, 96813
- University of Hawaii Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients must have a newly diagnosed Stage I, II, or III disease at the time of enrollment.
- Patients to be treated with adjuvant chemotherapy or recent initiation of (within 1 month of starting) adjuvant chemotherapy.
- Patients with a history of previous malignancy treated with chemotherapy within the last 3 years are not eligible, as their perceptions of care coordination may be impacted by their previous treatment.
- Patients must be ≥ 18 years of age.
- Patients must be able to read, write, and speak English. Study materials and telephone calls are only available in English.
- Patients must be residents of Hawaii, Kauai, or Maui counties
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video Intervention
The intervention in this study is a TED-talk style video series designed to provide patient education on cancer, care coordination, and self-advocacy.
The content is designed to provide both a background about cancer disease and to address each of the specific domains in care coordination (CCI).
The development of video contents was informed by our prior/current research in rural care coordination and components of evidence-based interventions including the patient navigator training by the George Washington University Cancer Institute, Imi Hale (the Native Hawaiian Cancer Network), and a supportive care intervention by Mokuau et al.
As the target population of this intervention is rural patients, videos include some rural-specific considerations related to care coordination.
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The following topics are addressed in each module of the videos:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in rural patients' perceptions of cancer care coordination as assessed by the Care Coordination Instrument at 4-6 months post-intervention.
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Rural patient satisfaction with video education materials as assessed by semi-structured telephone interview.
Time Frame: 6 months
|
6 months
|
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To examine patient demographic and clinical information collected from the background questionnaire as potential correlates of patients' perceptions of cancer care coordination at post-intervention
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2022
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
October 27, 2021
First Submitted That Met QC Criteria
December 10, 2021
First Posted (Actual)
December 17, 2021
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Okado 2021-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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