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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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.

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Other: ePRO-CTCAE application


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial, Single center, Open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>a mobile application using the PRO-CTCAE along with usual care | Other: ePRO-CTCAE application<br>* 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.<br>|
| No Intervention: Controlled Group<br>Usual care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' participation in symptom management | Patients' participation in reporting and managing symptoms due to cancer treatment will be measured using 7 questions developed by study team. Questions will be asked using 4 Likert scale. Minimum value is 0 and maximum value will be 21. Higher score means better outcome. | 8 weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 | State of well-being evaluated by an individual, including both physical, mental, social, and spiritual areas. This will be measured using relevant items of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Scores will be calculated by manual (0-100) and higher score means better quality of life. | 8 weeks after the intervention | 
| Unexpected visits | number of unexpected hospital visits (emergency room visits, unplanned outpatient visits, or unplanned hospitalization) due to symptoms or adverse events due to cancer treatment | 8 weeks after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRO-CTCAE, patient-reported outcome, mobile application, patient engagement