A Mobile Application, Oncpatient, to Assist Patients Undergoing Radiation Therapy

Pilot Study of Mobile Application Designed to Assist Patients Undergoing Radiation Therapy

This clinical trial determines how well the oncpatient mobile application work in assisting patients undergoing radiation treatment. Radiation therapy can be complex. The technology, daily treatments, and possible side effects can be confusing to prevent and manage. Traditional radiation patient education includes a large amount of information, including details of treatment logistics, side effect prevention, and management. However, this information is not always readily accessible or memorable through the long course of therapy, and critical details can be missed. Oncpatient is a mobile application intended to be a more convenient and accessible form of patient education and guidance that is readily available to help patients and their caretakers navigate through radiation treatment.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Internet-Based Intervention

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the feasibility of implementing a mobile application designed to be an educational resource designed for patients undergoing radiation treatment.

SECONDARY OBJECTIVES:

I. To assess patient opinions on the usability and helpfulness of the mobile application in helping them through radiation treatments.

II. To assess satisfaction with the mobile application and radiation treatment. III. To assess opinions on existing or new features for the mobile application to be given to future patients.

OUTLINE:

Patients use the oncpatient mobile application over the course of radiation therapy. Patients also complete a survey on the final day of radiation treatment.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: Colton Ladbury; Phone Number: 21279 626-256-4673; Email: cladbury@coh.org
      • Principal Investigator: Colton Ladbury

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 and older.
• Can read and speak English and provide informed consent.
• Diagnosed with cancer, any stage, any disease site.
• Must be consented to undergo a course of radiotherapy, starting within one month. No limits on duration of radiation apply. Patients must be consented prior to initiating radiotherapy, however.

• Has regular access to a mobile device.

  • Note: This requirement unfortunately leads to the exclusion of underserved patients who cannot afford to have a mobile device. Given that the goal of this study is to establish feasibility of a mobile application, there are no true alternatives, given that these patients would require access to a mobile device if this app were commercially available. However, for impacted patients, the relevant application and resources will be made available on iPads they can access during treatment and a website they can access on any web-enabled device, to ensure they have access as much as reasonably possible. Future iterations of the application will aim to increase access to the resource however possible, but limitations will always apply due to how the core functionality of the app requires a mobile device.

Exclusion Criteria:

• Less than 18 years old.
• Non-English speaking.
• Inability to operate a mobile device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care (oncpatient application, survey); Patients use the oncpatient mobile application over the course of radiation therapy. Patients also complete a survey on the final day of radiation treatment.	Other: Survey Administration; Complete survey; Other: Internet-Based Intervention; Use oncpatient mobile application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion rate	The percent of patients who indicate in the survey that they were able to download the application and use it at least once during radiation will be defined as the completion rate.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient opinions on the usability and helpfulness of the mobile application in helping them through radiation treatments	Survey responses and collected demographic data will be evaluated with descriptive statistics where possible. Free-text responses will be recorded and utilized by the application developers to inform future iterations of the application.	Up to 1 year
Satisfaction with the mobile application and radiation treatment	Survey responses and collected demographic data will be evaluated with descriptive statistics where possible. Free-text responses will be recorded and utilized by the application developers to inform future iterations of the application.	Up to 1 year
Opinions on existing or new features for the mobile application to be given to future patients	Survey responses and collected demographic data will be evaluated with descriptive statistics where possible. Free-text responses will be recorded and utilized by the application developers to inform future iterations of the application.	Up to 1 year

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Colton Ladbury, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Estimated): December 22, 2024
• Study Completion (Estimated): December 22, 2024

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 21564 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2021-13835 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No