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

Not Applicable

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Individuals (men and women) aged 18 years or older
Biopsy proven (recurrent or metastatic) advanced lung or gastrointestinal cancer
No limit on prior lines of therapy in the metastatic setting
ECOG performance status of 0-2
Estimated life expectancy of at least 6 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

Arm && Interventions

Group	Intervention	Description
Noona web-based symptom tracking tool	Use of Noona web- based symptom tracking tool	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with at least one symptom questionnaire (SQ) completed after enrollment using the PROMIS platform	6 months
Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) physical subscale score	baseline, 6 months	Scores goes from (1-5). 5=Excellent and 1=Poor
Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) mental subscale score	baseline, 6 months	Scores goes from (1-5). 5=Excellent and 1=Poor

Secondary Outcome Measures

Name	Time	Method
Average number of diary encounters	6 months	A Noona system log in is recorded as a diary encounter
Proportion of clinicians that report satisfactory use of the Noona system	6 months
Tabulated responses from Noona Patient Feedback questionnaire	6 months	Questions include patient response to question about getting started with the Noona system and ease of use and user experience.
Rate of SQ adherence	6 months	Rate of SQ adherence is defined as completing at least 70% of requested SQs
Change in overall Functional Assessment of Cancer Therapy-General (FACT-G) score	baseline, 6 months	Scores goes from (0-4). 4=Very Much and 0=Not at all
Symptom experience	6 months	Number of patient-reported symptoms by type and severity

Locations (2): Stanford Cancer Institute
🇺🇸
Palo Alto, California, United States
UCSF Helen Diller Medical Center
🇺🇸
San Francisco, California, United States