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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Hwakyung BYUN, Phd contact

007981072098955

hkbyun05@yuhs.ac

South Korea1 site, 1 recruiting

  • Yongin Severance Hospital

    Yongin-si, 365

    Hwakyung BYUN, Phd, 0079803151898166, hkbyun05@yuhs.ac

    Recruiting

Other trials in South Korea

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 groups in NCT06598293
Study groupRoleWhat they receive
Test group: REPROM groupSubjects 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 groupControl 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.

  1. 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.

  1. First posted19 Sep 2024
  2. Study start3 Sep 2024
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

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)
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 36241128

  • Bae 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 29732483

  • Steinbeck 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

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.

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