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Active, Not Recruiting

NCT Number: NCT05931445

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kobe University Graduate School

Kobe, Hyōgo, 650-0017, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: After enrollment to death from any cause (up to 57 months)

  2. 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

Secondary outcomes

  1. 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

  2. HRQoL EQ-5D-5L index score

    Time frame: At enrollment and every 4 weeks after enrollment up to 57 months

  3. Quality-adjusted life year (QALY) score

    Time frame: After enrollment to death from any cause (up to 57 months)

  4. At-home mortality rate

    Time frame: After enrollment to death from any cause (up to 57 months)

  5. 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)

  6. Number of unscheduled hospital visits during drug therapy

    Time frame: After enrollment up to 24 weeks

  7. Relative Dose Intensity (RDI)

    Time frame: After enrollment up to 24 weeks

  8. Total number of drug regiments

    Time frame: After enrollment up to 57 months

  9. Incremental Cost-Effectiveness Ratio (ICER)

    Time frame: After enrollment up to 57 months

  10. Communication between patients and healthcare providers (EORTC QLQ-COMU26 score)

    Time frame: At enrollment and week 24 after enrollment

Sponsors and collaborators

Lead sponsor

Comprehensive Support Project for Oncology Research

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jul 5, 2023
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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