Mobile Application Using the PRO-CTCAE to Improve Patients' Participation in Symptom Management During Treatment.
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| ClinicalTrials.gov Identifier: NCT04568278 |
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Recruitment Status :
Active, not recruiting
First Posted : September 29, 2020
Last Update Posted : July 8, 2021
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Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
Juhee Cho, Samsung Medical Center
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neoplasms | Other: ePRO-CTCAE application | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 222 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized Controlled Trial, Single center, Open label |
| Masking: | None (Open Label) |
| Masking Description: | Statistician who will analyze the results of the study will be blinded |
| Primary Purpose: | Supportive Care |
| 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. |
| Actual Study Start Date : | October 5, 2020 |
| Actual Primary Completion Date : | March 31, 2021 |
| Estimated Study Completion Date : | July 30, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Palliative Care
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention Group
a mobile application using the PRO-CTCAE along with usual care
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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. |
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No Intervention: Controlled Group
Usual care
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Primary Outcome Measures :
- Patients' participation in symptom management [ Time Frame: 8 weeks after the intervention ]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.
Secondary Outcome Measures :
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 [ Time Frame: 8 weeks after the intervention ]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.
- Unexpected visits [ Time Frame: 8 weeks after the intervention ]number of unexpected hospital visits (emergency room visits, unplanned outpatient visits, or unplanned hospitalization) due to symptoms or adverse events due to cancer treatment
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568278
Locations
| Korea, Republic of | |
| Danbee Kang | |
| Seoul, Korea, Republic of, 135-710 | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Samsung Medical Center
| Responsible Party: | Juhee Cho, Director, Cancer Education Center, Samsung Medical Center, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT04568278 |
| Other Study ID Numbers: |
ePRO-CTCAE_2020 |
| First Posted: | September 29, 2020 Key Record Dates |
| Last Update Posted: | July 8, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Juhee Cho, Samsung Medical Center:
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patient-reported outcome PRO-CTCAE mobile application patient engagement |