Clinical trial NCT05931445: Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Colorectal Cancer
Liver Cancer
Stomach Cancer
Endometrial Cancer
Ovarian Cancer
Squamous Cell Carcinoma of the Head and Neck
Lead sponsor: Comprehensive Support Project for Oncology Research
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 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)
2. Expected to be able to undergo treatment or observation for at least 6 months at the study site
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
4. 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.)
5. Capable of using electronic device (includes cases needing some assistance)
6. Aged 18 years or older at informed consent
7. Written consent for the study personally obtained from the subject

Exclusion Criteria:

1. Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors\*Notes 1, 2
2. Currently participating in a study where PRO is tracked and the results are passed on to a physician
3. 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
4. Undergoing or scheduled to undergo radiation therapy for curative purposes
5. Deemed otherwise unsuitable for the study by the investigator or sub-investigator

   * Notes:

     1. 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.
     2. Does not include endocrine therapy for breast cancer.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: After enrollment to death from any cause (up to 57 months)
measure: HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) global health status score
timeFrame: At enrollment and week 4,8,12,16,20 and 24 after enrollment
Secondary outcomes:
measure: HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) domain score
timeFrame: At enrollment and week 4,8,12,16,20 and 24 after enrollment
measure: HRQoL EQ-5D-5L index score
timeFrame: At enrollment and every 4 weeks after enrollment up to 57 months
measure: Quality-adjusted life year (QALY) score
timeFrame: After enrollment to death from any cause (up to 57 months)
measure: At-home mortality rate
timeFrame: After enrollment to death from any cause (up to 57 months)
measure: Time from last completion of drug therapy to death
timeFrame: Time from last completion of drug therapy to death from any cause (up to 57 months)
measure: Number of unscheduled hospital visits during drug therapy
timeFrame: After enrollment up to 24 weeks
measure: Relative Dose Intensity (RDI)
timeFrame: After enrollment up to 24 weeks
measure: Total number of drug regiments
timeFrame: After enrollment up to 57 months
measure: Incremental Cost-Effectiveness Ratio (ICER)
timeFrame: After enrollment up to 57 months
measure: Communication between patients and healthcare providers (EORTC QLQ-COMU26 score)
timeFrame: At enrollment and week 24 after enrollment
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University Graduate School
state: Hyogo
Study officials:
affiliation: Kobe University Graduate School
name: Hironobu Minami
role: PRINCIPAL_INVESTIGATOR
References: