Breast CancerNCT05931445
Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer
A study testing e-PRO monitoring in people with Breast Cancer and Lung Cancer, run by Comprehensive Support Project for Oncology Research at 1 site in Japan.
Trial summary
This is a multicenter, open-label, randomized, controlled study to test the hypothesis that ePRO monitoring added to usual care helps prolong OS or maintain and improve HRQoL in patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic drug therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Colorectal Cancer
- What is being tested?
- e-PRO monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteJapan
- Study dates
- 26 Jan 2021to 31 Mar 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable, advanced, metastasized, or relapsed solid tumors (Breast Cancer, Lung Cancer, Colorectal Cancer, Liver Cancer, Stomach Cancer, Endometrial Cancer, Ovarian Cancer, or Squamous Cell Carcinoma of the Head and Neck)
- Expected to be able to undergo treatment or observation for at least 6 months at the study site
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
- Receiving systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) at enrollment or scheduled to begin such therapy within 1 month from the date of enrollment (In principle, patients should be receiving pharmacotherapy on an out-patient basis.)
- Capable of using electronic device (includes cases needing some assistance)
- Aged 18 years or older at informed consent
- Written consent for the study personally obtained from the subject
Who cannot join
- Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors*Notes 1, 2
- Currently participating in a study where PRO is tracked and the results are passed on to a physician
- The following are exclusion criteria for individual types of cancer 1) Breast cancer
- Scheduled to receive or currently receiving endocrine therapy (including endocrine therapy in combination with other agents) for hormone receptor-positive breast cancer
- Scheduled to receive or currently receiving first regimen of anti-HER2 therapy for HER2-positive disease 2) Liver cancer
- Hepatic function of Child-Pugh B/C
Show all 11Show fewer
- Undergoing or scheduled to undergo radiation therapy for curative purposes
- Deemed otherwise unsuitable for the study by the investigator or sub-investigator
- Notes:
- If the disease has relapsed during perioperative adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy will be considered as the first regimen of adjuvant chemotherapy.
- Does not include endocrine therapy for breast cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Open-label, Randomized, Controlled Study to Test the Utility of Electronic Patient-reported Outcome (ePRO) Monitoring in Patients With Unresectable Advanced Cancers or Metastatic/Recurrent Solid Tumors
This is a multicenter, open-label, randomized, controlled study to test the hypothesis that ePRO monitoring added to usual care helps prolong OS or maintain and improve HRQoL in patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic drug therapy.
- Conditions
- Breast Cancer, Lung Cancer, Colorectal Cancer, Liver Cancer, Stomach Cancer, Endometrial Cancer
- Being tested
- e-PRO monitoring
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Liver Neoplasms, Stomach Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-PRO monitoringOther
The e-PRO monitoring will concern treatment of each predefined type of cancer or characteristic symptoms of the condition. PRO-CTCAE (Patient-Reported Outcome-Common Terminology Criteria for Adverse Events) will be used as the scale for monitoring symptoms. The patient and (sub)investigator will share the monitoring results during examinations and use them to determine treatment strategies, etc. Threshold values will be predefined for a diagnosis of "severe" for individual symptoms. When it is reported that a threshold value has been exceeded, an alert notification will be sent to the study staff member assigned to the patient. The (sub)investigator who receives the notification will assess the information in the notification and take the best course of action.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring group | Experimental | ePRO monitoring will be conducted once weekly after study enrollment, along with standard care of treatment. Receives: Other: e-PRO monitoring |
| Non-monitoring group | No intervention | Standard care of treatment will be given without ePRO monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: After enrollment to death from any cause (up to 57 months)
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) global health status score
Measured: At enrollment and week 4,8,12,16,20 and 24 after enrollment
Secondary outcomes (10)
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) domain score
Measured: At enrollment and week 4,8,12,16,20 and 24 after enrollment
HRQoL EQ-5D-5L index score
Measured: At enrollment and every 4 weeks after enrollment up to 57 months
Quality-adjusted life year (QALY) score
Measured: After enrollment to death from any cause (up to 57 months)
At-home mortality rate
Measured: After enrollment to death from any cause (up to 57 months)
Time from last completion of drug therapy to death
Measured: Time from last completion of drug therapy to death from any cause (up to 57 months)
Number of unscheduled hospital visits during drug therapy
Measured: After enrollment up to 24 weeks
Relative Dose Intensity (RDI)
Measured: After enrollment up to 24 weeks
Total number of drug regiments
Measured: After enrollment up to 57 months
Incremental Cost-Effectiveness Ratio (ICER)
Measured: After enrollment up to 57 months
Communication between patients and healthcare providers (EORTC QLQ-COMU26 score)
Measured: At enrollment and week 24 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start26 Jan 2021
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comprehensive Support Project for Oncology Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hironobu Minami, Principal investigator, Kobe University Graduate School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931445
- Sponsor's protocol ID
- PRO-MOTE
- Status last verified
- May 2023
- First submitted
- 5 Jun 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Randomized, Controlled Study to Test the Utility of Electronic Patient-reported Outcome (ePRO) Monitoring in Patients With Unresectable Advanced Cancers or Metastatic/Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT05931445
- Acronym / sponsor ID
- PRO-MOTE
- Conditions
- Breast Cancer, Lung Cancer, Colorectal Cancer, Liver Cancer, Stomach Cancer, Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Comprehensive Support Project for Oncology ResearchUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Jul 2023 (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.
This is a multicenter, open-label, randomized, controlled study to test the hypothesis that ePRO monitoring added to usual care helps prolong OS or maintain and improve HRQoL in patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic drug therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring group | Experimental | Other: e-PRO monitoringePRO monitoring will be conducted once weekly after study enrollment, along with standard care of treatment. |
| Non-monitoring group | No intervention | –Standard care of treatment will be given without ePRO monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unresectable, advanced, metastasized, or relapsed solid tumors (Breast Cancer, Lung Cancer, Colorectal Cancer, Liver Cancer, Stomach Cancer, Endometrial Cancer, Ovarian Cancer, or Squamous Cell Carcinoma of the Head and Neck)
- Expected to be able to undergo treatment or observation for at least 6 months at the study site
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
- Receiving systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) at enrollment or scheduled to begin such therapy within 1 month from the date of enrollment (In principle, patients should be receiving pharmacotherapy on an out-patient basis.)
- Capable of using electronic device (includes cases needing some assistance)
Key exclusion criteria (11 listed)
- Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors*Notes 1, 2
- Currently participating in a study where PRO is tracked and the results are passed on to a physician
- The following are exclusion criteria for individual types of cancer 1) Breast cancer
- Undergoing or scheduled to undergo radiation therapy for curative purposes
- Deemed otherwise unsuitable for the study by the investigator or sub-investigator
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 |
|---|---|---|
| e-PRO monitoringThe e-PRO monitoring will concern treatment of each predefined type of cancer or characteristic symptoms of the condition. PRO-CTCAE (Patient-Reported Outcome-Common Terminology Criteria for Adverse Events) will be used as the scale for monitoring symptoms. The patient and (sub)investigator will share the monitoring results during examinations and use them to determine treatment strategies, etc. Threshold values will be predefined for a diagnosis of "severe" for individual symptoms. When it is reported that a threshold value has been exceeded, an alert notification will be sent to the study staff member assigned to the patient. The (sub)investigator who receives the notification will assess the information in the notification and take the best course of action. | Other | Monitoring group |
Primary outcome
Overall Survival (OS)
Time frame: After enrollment to death from any cause (up to 57 months)
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) global health status score
Time frame: At enrollment and week 4,8,12,16,20 and 24 after enrollment
10 secondary outcomes
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) domain score
Time frame: At enrollment and week 4,8,12,16,20 and 24 after enrollment
HRQoL EQ-5D-5L index score
Time frame: At enrollment and every 4 weeks after enrollment up to 57 months
Quality-adjusted life year (QALY) score
Time frame: After enrollment to death from any cause (up to 57 months)
At-home mortality rate
Time frame: After enrollment to death from any cause (up to 57 months)
Time from last completion of drug therapy to death
Time frame: Time from last completion of drug therapy to death from any cause (up to 57 months)
Number of unscheduled hospital visits during drug therapy
Time frame: After enrollment up to 24 weeks
Relative Dose Intensity (RDI)
Time frame: After enrollment up to 24 weeks
Total number of drug regiments
Time frame: After enrollment up to 57 months
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: After enrollment up to 57 months
Communication between patients and healthcare providers (EORTC QLQ-COMU26 score)
Time frame: At enrollment and week 24 after enrollment
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 23 Apr 2024.
- 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. This study is not recruiting at the moment.
Hironobu Minami principal investigator
Kobe University Graduate School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-PRO monitoring in people with Breast Cancer and Lung Cancer, run by Comprehensive Support Project for Oncology Research at 1 site in Japan.
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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 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 Japan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: After enrollment to death from any cause (up to 57 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2024.