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

Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04568278
• Other study ID #: ePRO-CTCAE_2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: July 2021
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 222
• Est. completion date: July 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Danbee Kang	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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