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

NCT05931445 | Active Not Recruiting DMC

• 1 other identifier: PRO-MOTE
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• 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

• 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)

Study Arms (2)

Monitoring group

EXPERIMENTAL

ePRO monitoring will be conducted once weekly after study enrollment, along with standard care of treatment.

Other: e-PRO monitoring

Non-monitoring group

NO INTERVENTION

Standard care of treatment will be given without ePRO monitoring.

Interventions

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.

Monitoring group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Comprehensive Support Project for Oncology Research: lead

Study Sites (1)

Kobe University Graduate School

Kobe, Hyōgo, 650-0017, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Liver Neoplasms; Stomach Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases; Stomach Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms

Study Officials

• Hironobu Minami

  Kobe University Graduate School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 5, 2023
• Study Start: January 26, 2021
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 23, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)