Digital Symptom Tracking in Assessing Patient Engagement and Quality of Life in Recurrent or Advanced Cancer

Status: closed to accrual

This clinical trials examines digital symptom tracking in assessing patient engagement and quality of life in patients with cancer that has come back (recurrent) or has spread to other places in the body (advanced). A web-based application allows patients to log symptoms using a digital tracking tool designed to help describe and summarize symptoms for their oncology team. This study may help doctors learn about cancer-related symptom experienced by patients and different ways to report physical and emotional symptoms related to cancer and its treatment.

Inclusion Criteria

New and established patients aged 18 years or older, and on active treatment
Access to smartphone, tablet or computer with capability to utilize a symptom tracking application
Recurrent or metastatic advanced lung, gastrointestinal, renal, bladder or castrate resistant prostate cancer
No limit on prior lines of therapy in the metastatic setting; must be on active treatment while enrolled in the study, but may have already started their treatment prior to enrollment
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Estimated life expectancy of at least 6 months
Willing and able to comply with all study procedures
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

Exclusion Criteria

Concurrent disease or condition that interferes with participation or safety
Non-English speaking, as the application is developed in the English language
Non-castrate resistant prostate cancer
Enrolled in other non-therapeutic or therapeutic clinical trials

PRIMARY OBJECTIVES:

I. Describe feasibility of a patient reported outcome (PRO) platform at two academic medical centers: Stanford and University of California San Francisco (UCSF) (at least one symptom questionnaire [SQ] completed after enrollment).

II. Identify differences in health related quality of life (HRQL) using Patient Reported Outcomes Measurement Information System-General (PROMIS-G).

SECONDARY OBJECTIVES:

I. Describe other measures of feasibility of a PRO platform (rate of SQ adherence and average number of diary encounters).

II. Identify differences in health related quality of life (HRQL) using Functional Assessment of Cancer Therapy General (FACT-G).

III. Describe the symptom experience of patients on the Noona arm (Noona analytics).

IV. Characterize clinician satisfaction.

V. Characterize patient satisfaction.

EXPLORATORY OBJECTIVES:

I. Identify differences in unplanned care (hospital admissions, emergency room admission, symptom management visits).

II. Describe differences in symptom documentation in the PRO versus (vs.) usual care arm.

III. Identify differences in referrals (i.e. to PathWell services)- Stanford’s supportive care services (EPIC electronic health record [EHR]) and SMS and Cancer Center Resources services at UCSF.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients use web-based tool to report cancer-related symptoms. Patients also complete questionnaire over 10 minutes at baseline, 3 and 6 months, and 1 year.

GROUP II: Patients use standard tool to report cancer-related symptoms. Patients also complete questionnaire over 10 minutes at baseline, 3 and 6 months, and 1 year.

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Digital Symptom Tracking in Assessing Patient Engagement and Quality of Life in Recurrent or Advanced Cancer

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