NCT05162404

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

January 5, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

October 27, 2021

Last Update Submit

December 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Rural patient satisfaction with video education materials as assessed by semi-structured telephone interview.

    6 months

  • 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

Study Arms (1)

Video Intervention

EXPERIMENTAL

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.

Behavioral: Video Education Program

Interventions

The following topics are addressed in each module of the videos: 1. Understanding cancer and cancer treatment - including an understanding of stage, site of origin, metastases, treatment options, toxicities and anticipated outcomes. 2. 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). 3. 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.

Video Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Related Publications (1)

  • Okado I, Braun-Inglis C, Matsumoto K, Elhajj C, Cassel K, Berenberg J, Holcombe RF. Feasibility of a Remote Patient Video Education Intervention to Improve Care Coordination for Rural Cancer Patients. J Cancer Educ. 2025 Aug;40(4):594-599. doi: 10.1007/s13187-024-02550-6. Epub 2024 Dec 5.

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2021

First Posted

December 17, 2021

Study Start

January 5, 2022

Primary Completion

February 28, 2023

Study Completion

July 1, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations