CancerREPROMNCT06598293
Routine Electronic Patient-reported Outcome Measures During and After Radiotherapy: A Randomized Controlled Study
An observational study of Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Patients in this study will be asked to periodically self-report their symptoms using their smartphones during the radiotherapy period and during the acute phase (3 months) after treatment, and radiation oncology physicians will evaluate the impact on cancer patients' quality of life and determine whether they can… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PRO-CTCAE, Pain NRS
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 536 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Sep 2024to 28 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korean patients who visited the hospital and will receive treatment from the radiation oncology department
Who may be able to join
- Age > 18
- Histologically confirmed diagnosis of cancer
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- The ability to own and use a smartphone
Who cannot join
- Terminal cancer
- Cognitive impairment
- Not using your smartphone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yongin Severance Hospital
Yongin-si, 365
Hwakyung BYUN, Phd, 0079803151898166, hkbyun05@yuhs.ac
About this study
Official title: Routine Electronic Patient-reported Outcome Measures During and After Radiotherapy: A Randomized Controlled Study (REPROM)
Patients in this study will be asked to periodically self-report their symptoms using their smartphones during the radiotherapy period and during the acute phase (3 months) after treatment, and radiation oncology physicians will evaluate the impact on cancer patients' quality of life and determine whether they can improve health outcomes by using this data in their practice.
Read the detailed description
The purpose of this study is to determine the efficacy, feasibility, and acceptability of routine PROM reporting using smartphones during treatment and during the acute phase after treatment in patients undergoing radiotherapy.
Subjects who voluntarily consent to the study will be assigned to either the test group or the control group through randomization.
- Test group: REPROM group Subjects in the test group will self-report symptoms that occur using smartphones before radiotherapy, once a week during treatment, at the end of treatment, once a week until one month after treatment, and at 1 month and 3~6 months after treatment (PRO-CTCAE, Pain NRS). The radiation oncologist will identify the symptoms reported in the REPROM and take appropriate medical measures to improve the symptoms based on this.
A survey alert is sent to the patient at the time of REPROM implementation, and the subject uses a smartphone to conduct a self-report questionnaire on patient symptoms sent through the mobile messenger KakaoTalk as shown in the screenshot below. The survey data is automatically sent to the EMR and can be checked by the attending physician at the time of consultation. A score of 4 or higher will be automatically alerted to the attending physician and the research nurse, and the research nurse may contact the subject if necessary and recommend additional care to the attending physician.
- Control group: Usual care group Control subjects receive usual care without self-report of REPROM. Subjects in both groups may receive appropriate medical attention for the symptoms observed at the time of treatment. Subjects in both groups will be asked to take HR-QOL questionnaires (EORTC-QLQ-C30, EQ-5D-5L, EQ-VAS) before radiotherapy, at the end of treatment, at 1 month after treatment, and at 3~6 months after treatment.
*Study design: a prospective randomized parallel-group pilot study
- Conditions
- Cancer
- Being tested
- PRO-CTCAE, Pain NRS
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-CTCAE, Pain NRSBehavioural
The Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a PROM developed to systematically and objectively reflect patients' experiences and perceptions of therapeutic drugs in toxicity evaluation and adverse event reporting. PRO-CTCAE can be used to monitor patients' symptoms and side effects, support therapeutic decision-making, facilitate communication among medical staff, implement patient-centred care, and screen for health conditions.
| Study group | Role | What they receive |
|---|---|---|
| Test group: REPROM group | Subjects in the test group will self-report symptoms that occur using smartphones before radiotherapy, once a week during treatment, at the end of treatment, once a week until one month after treatment, and at 1 month and 3~6 months after treatment (PRO-CTCAE, Pain NRS). The radiation oncologist will identify the symptoms reported in the REPROM and take appropriate medical measures to improve the symptoms based on this.
A survey alert will be sent to the patient at the time of REPROM implementation, and the subject will self-report the patient's symptoms through the mobile messenger KakaoTalk using a smartphone. The survey data is automatically sent to the EMR and can be checked by the attending physician at the time of consultation. A score of 4 or higher will be automatically alerted to the attending physician and the research nurse, and the research nurse may contact the subject if necessary and recommend additional care to the attending physician. Receives: Behavioral: PRO-CTCAE, Pain NRS | |
| Control group: Standard care group | Control subjects receive standard care without self-report of REPROM. Both groups may receive appropriate medical attention for the symptoms observed at the time of examination. Both groups will administer HR-QOL questionnaires (EORTC-QLQ-C30, EQ-5D-5L, EQ-VAS) before radiotherapy, at the end of treatment, 1 month after treatment, and 3~6 months after treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change score from baseline in Quality of Life Assessment Tool (EORTC-QLQ-C30)
Comparison of quality of life assessment tool scores between groups is performed using independent t-test. Linear mixed-effect model is used in the intention-to-treat study population. Age, sex, pretreatment PROM score, cancer type, and stage are controlled as fixed covariates, and radiation oncology and attending physician are controlled as random intercepts. For sensitivity analysis, additional analysis is performed on patients who completed more than 80% of the REPROM questionnaire. Since this study is an exploratory analysis, a two-sided significance level of .05 is used for all comparisons without redundancy adjustment.
Measured: 36 months after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Sep 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hwa Kyung Byun, Yonsei University
- Investigators
- Hwakyung BYUN, Phd, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598293
- Sponsor's protocol ID
- 9-2024-0095
- Acronym
- REPROM
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holch P, Absolom KL, Henry AM, Walker K, Gibson A, Hudson E, Rogers Z, Holmes M, Peacock R, Pini S, Gilbert A, Davidson S, Routledge J, Murphy A, Franks K, Hulme C, Hewison J, Morris C, McParland L, Brown J, Velikova G. Online Symptom Monitoring During Pelvic Radiation Therapy: Randomized Pilot Trial of the eRAPID Intervention. Int J Radiat Oncol Biol Phys. 2023 Mar 1;115(3):664-676. doi: 10.1016/j.ijrobp.2022.09.078. Epub 2022 Oct 12.
PubMed 36241128Bae WK, Kwon J, Lee HW, Lee SC, Song EK, Shim H, Ryu KH, Song J, Seo S, Yang Y, Park JH, Lee KH, Han HS. Feasibility and accessibility of electronic patient-reported outcome measures using a smartphone during routine chemotherapy: a pilot study. Support Care Cancer. 2018 Nov;26(11):3721-3728. doi: 10.1007/s00520-018-4232-z. Epub 2018 May 7.
PubMed 29732483Steinbeck V, Langenberger B, Schoner L, Wittich L, Klauser W, Mayer M, Kuklinski D, Vogel J, Geissler A, Pross C, Busse R. Electronic Patient-Reported Outcome Monitoring to Improve Quality of Life After Joint Replacement: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2331301. doi: 10.1001/jamanetworkopen.2023.31301.
PubMed 37656459
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Electronic Patient-reported Outcome Measures During and After Radiotherapy: A Randomized Controlled Study (REPROM)
- ClinicalTrials.gov ID
- NCT06598293
- Acronym / sponsor ID
- REPROM / 9-2024-0095
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients in this study will be asked to periodically self-report their symptoms using their smartphones during the radiotherapy period and during the acute phase (3 months) after treatment, and radiation oncology physicians will evaluate the impact on cancer patients' quality of life and determine whether they can improve health outcomes by using this data in their practice.
Detailed description
The purpose of this study is to determine the efficacy, feasibility, and acceptability of routine PROM reporting using smartphones during treatment and during the acute phase after treatment in patients undergoing radiotherapy.
Subjects who voluntarily consent to the study will be assigned to either the test group or the control group through randomization.
- Test group: REPROM group Subjects in the test group will self-report symptoms that occur using smartphones before radiotherapy, once a week during treatment, at the end of treatment, once a week until one month after treatment, and at 1 month and 3~6 months after treatment (PRO-CTCAE, Pain NRS). The radiation oncologist will identify the symptoms reported in the REPROM and take appropriate medical measures to improve the symptoms based on this.
A survey alert is sent to the patient at the time of REPROM implementation, and the subject uses a smartphone to conduct a self-report questionnaire on patient symptoms sent through the mobile messenger KakaoTalk as shown in the screenshot below. The survey data is automatically sent to the EMR and can be checked by the attending physician at the time of consultation. A score of 4 or higher will be automatically alerted to the attending physician and the research nurse, and the research nurse may contact the subject if necessary and recommend additional care to the attending physician.
- Control group: Usual care group Control subjects receive usual care without self-report of REPROM. Subjects in both groups may receive appropriate medical attention for the symptoms observed at the time of treatment. Subjects in both groups will be asked to take HR-QOL questionnaires (EORTC-QLQ-C30, EQ-5D-5L, EQ-VAS) before radiotherapy, at the end of treatment, at 1 month after treatment, and at 3~6 months after treatment.
*Study design: a prospective randomized parallel-group pilot study
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group: REPROM group | – | Behavioral: PRO-CTCAE, Pain NRSSubjects in the test group will self-report symptoms that occur using smartphones before radiotherapy, once a week during treatment, at the end of treatment, once a week until one month after treatment, and at 1 month and 3~6 months after treatment (PRO-CTCAE, Pain NRS). The radiation oncologist will identify the symptoms reported in the REPROM and take appropriate medical measures to improve the symptoms based on this. A survey alert will be sent to the patient at the time of REPROM implementation, and the subject will self-report the patient's symptoms through the mobile messenger KakaoTalk using a smartphone. The survey data is automatically sent to the EMR and can be checked by the attending physician at the time of consultation. A score of 4 or higher will be automatically alerted to the attending physician and the research nurse, and the research nurse may contact the subject if necessary and recommend additional care to the attending physician. |
| Control group: Standard care group | – | –Control subjects receive standard care without self-report of REPROM. Both groups may receive appropriate medical attention for the symptoms observed at the time of examination. Both groups will administer HR-QOL questionnaires (EORTC-QLQ-C30, EQ-5D-5L, EQ-VAS) before radiotherapy, at the end of treatment, 1 month after treatment, and 3~6 months after treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean patients who visited the hospital and will receive treatment from the radiation oncology department
Key inclusion criteria (4 listed)
- Age > 18
- Histologically confirmed diagnosis of cancer
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- The ability to own and use a smartphone
Key exclusion criteria (3 listed)
- Terminal cancer
- Cognitive impairment
- Not using your smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO-CTCAE, Pain NRSThe Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a PROM developed to systematically and objectively reflect patients' experiences and perceptions of therapeutic drugs in toxicity evaluation and adverse event reporting. PRO-CTCAE can be used to monitor patients' symptoms and side effects, support therapeutic decision-making, facilitate communication among medical staff, implement patient-centred care, and screen for health conditions. | Behavioural | Test group: REPROM group |
Primary outcome
Mean change score from baseline in Quality of Life Assessment Tool (EORTC-QLQ-C30)
Time frame: 36 months after registration
Comparison of quality of life assessment tool scores between groups is performed using independent t-test. Linear mixed-effect model is used in the intention-to-treat study population. Age, sex, pretreatment PROM score, cancer type, and stage are controlled as fixed covariates, and radiation oncology and attending physician are controlled as random intercepts. For sensitivity analysis, additional analysis is performed on patients who completed more than 80% of the REPROM questionnaire. Since this study is an exploratory analysis, a two-sided significance level of .05 is used for all comparisons without redundancy adjustment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Background: PubMed 36241128Holch P, Absolom KL, Henry AM, Walker K, Gibson A, Hudson E, Rogers Z, Holmes M, Peacock R, Pini S, Gilbert A, Davidson S, Routledge J, Murphy A, Franks K, Hulme C, Hewison J, Morris C, McParland L, Brown J, Velikova G. Online Symptom Monitoring During Pelvic Radiation Therapy: Randomized Pilot Trial of the eRAPID Intervention. Int J Radiat Oncol Biol Phys. 2023 Mar 1;115(3):664-676. doi: 10.1016/j.ijrobp.2022.09.078. Epub 2022 Oct 12.
- Background: PubMed 29732483Bae WK, Kwon J, Lee HW, Lee SC, Song EK, Shim H, Ryu KH, Song J, Seo S, Yang Y, Park JH, Lee KH, Han HS. Feasibility and accessibility of electronic patient-reported outcome measures using a smartphone during routine chemotherapy: a pilot study. Support Care Cancer. 2018 Nov;26(11):3721-3728. doi: 10.1007/s00520-018-4232-z. Epub 2018 May 7.
- Results publication: PubMed 37656459Steinbeck V, Langenberger B, Schoner L, Wittich L, Klauser W, Mayer M, Kuklinski D, Vogel J, Geissler A, Pross C, Busse R. Electronic Patient-Reported Outcome Monitoring to Improve Quality of Life After Joint Replacement: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2331301. doi: 10.1001/jamanetworkopen.2023.31301.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hwakyung BYUN, Phd principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hwakyung BYUN, Phd (007981072098955, hkbyun05@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change score from baseline in Quality of Life Assessment Tool (EORTC-QLQ-C30) (time frame: 36 months after registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06598293, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.