Digital Symptom Tracking, Patient Engagement and Quality of Life in Advanced Cancer

Stanford University

Status: Active, not recruiting

Conditions: Quality of Life

Treatments: Device: Use of Noona web- based symptom tracking tool

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05112198

IRB-38423

NCI-2021-12414 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to (1) describe patient and clinician engagement in web-based symptom self-monitoring, (2) identify differences in symptom management between intervention and usual care groups, and (3) identify potential outcomes of real-time symptom tracking and management.

With the assistance of the study coordinator, participants randomized to the intervention will create an account with Noona. Patients will be instructed to log symptoms as often as relevant using their own personal devices. Patients will also be prompted once per week for 24 weeks to log any recent symptoms. These participants will be sent a Symptom Questionnaire (SQ) via the Noona tool that summarizes their symptoms and distress one week prior to each oncology clinic visit. Symptoms designated as clinically severe either during regular symptom logging or via the SQ will trigger a prompt to contact the clinical team for immediate follow-up.

Full description

New patients from three cancer care programs (thoracic oncology, gastrointestinal oncology, and palliative care) at two academic institutions (Stanford and UCSF) will be screened for demographic and disease stage data within the patient medical record. Eligible patients will be asked by their oncology team whether they would be interested in participating a study of symptom management in oncology care.

Patients who express interest and ability to participate will be interviewed to determine eligibility.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Individuals (men and women) aged 18 years or older
2. Biopsy proven (recurrent or metastatic) advanced lung or gastrointestinal cancer
3. No limit on prior lines of therapy in the metastatic setting
4. ECOG performance status of 0-2
5. Estimated life expectancy of at least 6 months
6. Access to smartphone, tablet or computer with capability to utilize symptom tracking application
7. 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
8. Willing and able to comply with all study procedures

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Noona web-based symptom tracking tool

Experimental group

Description:

In addition to usual care for their disease, patients interact with Noona system and system questioners to record their symptoms over a period of 6 months.

Treatment:

Device: Use of Noona web- based symptom tracking tool

Usual Care

No Intervention group

Description:

Participants will receive the standard of care for their disease