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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05162404
Other study ID # Okado 2021-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 5, 2022
Est. completion date July 1, 2023

Study information

Verified date December 2023
Source University of Hawaii
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date July 1, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Video Education Program
The following topics are addressed in each module of the videos: Understanding cancer and cancer treatment - including an understanding of stage, site of origin, metastases, treatment options, toxicities and anticipated outcomes. Care coordination basics (CC: Communication) - including navigating care related to appointments, how to handle issues after-hours, and the expected roles of other healthcare providers (e.g., PCPs). How to be a self-advocate (CC: Navigation and Operational) - including how to ask questions, being empowered to talk to your doctor, when a second opinion is needed, when to explore clinical trials, and how to best incorporate a caregiver into your treatment.

Locations

Country Name City State
United States University of Hawaii Cancer Center Honolulu Hawaii

Sponsors (2)

Lead Sponsor Collaborator
University of Hawaii The Hope Foundation for Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in rural patients' perceptions of cancer care coordination as assessed by the Care Coordination Instrument at 4-6 months post-intervention. 6 months
Secondary Rural patient satisfaction with video education materials as assessed by semi-structured telephone interview. 6 months
Secondary 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 6 months
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