Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer

Trial Title: Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer

NCT ID: NCT05931445

Condition: Breast Cancer
Lung Cancer
Colorectal Cancer
Liver Cancer
Stomach Cancer
Endometrial Cancer
Ovarian Cancer
Squamous Cell Carcinoma of the Head and Neck

Conditions: Official terms:
Endometrial Neoplasms
Squamous Cell Carcinoma of Head and Neck
Stomach Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: e-PRO monitoring
Description: 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.
Arm group label: Monitoring group

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Kobe University Graduate School

Address:
City: Kobe
Zip: 650-0017
Country: Japan

Start date: January 26, 2021

Completion date: March 31, 2027

Lead sponsor:
Agency: Comprehensive Support Project for Oncology Research
Agency class: Other

Source: Comprehensive Support Project for Oncology Research

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05931445