Clinical trial NCT04568278: Mobile Application Using the PRO-CTCAE to Improve Patients' Participation in Symptom Management During Treatment.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Keywords: patient-reported outcome
PRO-CTCAE
mobile application
patient engagement
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial, Single center, Open label
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patients' participation in symptom management
timeFrame: 8 weeks after the intervention
Secondary outcomes:
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30
timeFrame: 8 weeks after the intervention
measure: Unexpected visits
timeFrame: 8 weeks after the intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Danbee Kang
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: