Mobile Application Using the PRO-CTCAE to Improve Patients' Participation in Symptom Management During Treatment.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2021-07-30

Brief Summary

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This study aims to evaluate the effect of a mobile application system using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to improve patients' participation in symptom management during cancer treatment. Our hypothesis is that patients who use a mobile application using the PRO-CTCAE will more likely to recognize symptoms due to cancer treatment and report them better to their clinicians than patients who do not use the mobile application.

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Detailed Description

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This is a randomized controlled trial to evaluate the effect of a mobile application system using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to improve patients' participation in symptom management during cancer treatment. Breast, lung, head and neck, esophagus, and gynecologic cancer patients who will begin new lines of chemotherapy or radiation therapy will be randomly assigned into the intervention and control groups (2:1 ratio). The intervention group will have the mobile application installed on their smart phones which they could record symptoms and adverse events due to cancer treatments using the pre-specified PRO-CTCAE questions for different types of cancer. The control group will have usual care. Primary endpoint is patients' participation/engagement of reporting symptoms and it will be evaluated at 8 weeks after the intervention using a questionnaire developed by the research team. Secondary end points are unexpected hospital visits during treatment during 8 weeks after the beginning of the treatment and quality of life at 8 weeks after the intervention.

Conditions

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Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial, Single center, Open label

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Statistician who will analyze the results of the study will be blinded

Study Groups

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Intervention Group

a mobile application using the PRO-CTCAE along with usual care

Group Type EXPERIMENTAL

ePRO-CTCAE application

Intervention Type OTHER

The intervention will be the use of a mobile application for recording symptoms during cancer treatments. Patients in the intervention group will have the mobile application (e-PRO) installed on their smart phones on the first day of cancer treatment (chemotherapy or radiation therapy) and patients will be asked to use the application for 8 weeks. Every week, the application will ask patients to report symptoms they experienced during past 7 days using the pre-specified PRO-CTCAE questions for different types of cancer. Patients also can memo and save photos related symptoms using the application and patients can monitor the progression of the symptoms over time.

Controlled Group

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ePRO-CTCAE application

The intervention will be the use of a mobile application for recording symptoms during cancer treatments. Patients in the intervention group will have the mobile application (e-PRO) installed on their smart phones on the first day of cancer treatment (chemotherapy or radiation therapy) and patients will be asked to use the application for 8 weeks. Every week, the application will ask patients to report symptoms they experienced during past 7 days using the pre-specified PRO-CTCAE questions for different types of cancer. Patients also can memo and save photos related symptoms using the application and patients can monitor the progression of the symptoms over time.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who are scheduled to have chemotherapy or radiation therapy.
* Patients who own a smartphone (Android) and who can use mobile applications.
* Patients who understand the purpose of this study and agree to participate in the study
* Patients age over 18 years old (no age limit, but if necessary informed consent of the caregivers will be obtained for the patients whose age are over 70 years old)

Exclusion Criteria

* Patients whose life expectancy is less than 6 months (hospice)
* Patients who would any physical or mental problems that would make them difficult to use the applications

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No