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

Samsung Medical Center

Status

Unknown

Conditions

Neoplasms

Treatments

Other: ePRO-CTCAE application

Study type

Interventional

Funder types

Other

Identifiers

NCT04568278

ePRO-CTCAE_2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

222 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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