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Spots Global Cancer Trial Database for Mobile Application Using the PRO-CTCAE to Improve Patients' Participation in Symptom Management During Treatment.

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Trial Identification

Brief Title: 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 ID: NCT04568278

Conditions

Neoplasms

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Danbee Kang, Seoul, , Korea, Republic of

Samsung Medical Center, Seoul, , Korea, Republic of

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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