Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitoring group | Experimental | ePRO 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-PRO monitoring | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 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 | At enrollment and week 4,8,12,16,20 and 24 after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) domain score | At enrollment and week 4,8,12,16,20 and 24 after enrollment | |
| HRQoL EQ-5D-5L index score | At enrollment and every 4 weeks after enrollment up to 57 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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
Notes:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hironobu Minami | Kobe University Graduate School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe University Graduate School | Kobe | Hyōgo | 650-0017 | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Quality-adjusted life year (QALY) score | After enrollment to death from any cause (up to 57 months) |
| At-home mortality rate | After enrollment to death from any cause (up to 57 months) |
| Time from last completion of drug therapy to death | Time from last completion of drug therapy to death from any cause (up to 57 months) |
| Number of unscheduled hospital visits during drug therapy | After enrollment up to 24 weeks |
| Relative Dose Intensity (RDI) | After enrollment up to 24 weeks |
| Total number of drug regiments | After enrollment up to 57 months |
| Incremental Cost-Effectiveness Ratio (ICER) | After enrollment up to 57 months |
| Communication between patients and healthcare providers (EORTC QLQ-COMU26 score) | At enrollment and week 24 after enrollment |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008113 | Liver Neoplasms |
| D013274 | Stomach Neoplasms |
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D008107 | Liver Diseases |
| D013272 | Stomach Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
Not provided
Not provided