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NCT03459352 | Completed | Cancer

Digital Symptom Tracking, Patient Engagement and Quality of Life in GI Oncology Clinic Patients
Sponsor:

Duke University

Brief Summary:

A pilot study of an ePRO system in cancer patients receiving systemic therapies.

Condition or disease

Cancer

Intervention/treatment

ePRO

Phase

Not Applicable

Detailed Description:

The primary purpose of this pilot study is to determine the feasibility of the Noona Healthcare Mobile PRO Application to describe oncology patient engagement using a web-based symptom self-monitoring instrument. Additionally, the studyy will dentify side effects as well as long term or chronic adverse events during and following cancer therapy based on the United States (US) National Cancer Institute (NCI) Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), and identify patients to participate in future long-term Quality of Life studies following cancer therapy. The study is not intended to compare outcomes between groups receiving different therapies.}}

Study Type : Interventional
Estimated Enrollment : 38 participants
Masking : None (Open Label)
Primary Purpose : Health Services Research
Official Title : Feasibility Study of Digital Symptom Tracking, Patient Engagement and Quality of Life in Patients Seen in GI Oncology Clinic
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : April 4, 2020
Estimated Study Completion Date : April 4, 2020
Arm Intervention/treatment

Experimental: ePRO

There is no therapeutic intervention. Patients will use ePRO system to report systems. We will describe use in patients to determine compliance in reporting symptoms.

Other: ePRO
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Individuals (men and women) aged 18 years or older
  • History cancer with no limitation on prior lines of therapy in the metastatic setting
  • ECOG performance status of 0-2
  • Estimated life expectancy of at least 12 months
  • Access to smartphone, tablet or computer with capability to utilize symptom-tracking application
  • Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
  • Willing and able to comply with all study procedures
Exclusion Criteria
  • Concurrent disease or condition that interferes with participation or safety
  • Non-English speaking, as the application is developed in the English language
  • Children will not be included in the study. The pattern of disease and symptoms are different in children than in an adult population. The web-based tool was designed based on the symptom experience of adults with cancer.
Digital Symptom Tracking, Patient Engagement and Quality of Life in GI Oncology Clinic Patients

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Digital Symptom Tracking, Patient Engagement and Quality of Life in GI Oncology Clinic Patients

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710