Clinical trial NCT05112198: Digital Symptom Tracking, Patient Engagement and Quality of Life in Advanced Cancer
Official title: Digital Symptom Tracking, Patient Engagement and Quality of Life in Advanced Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Quality of Life
Keywords: Patient and clinician engagement
Digital Symptom Tracking
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2021-11-08
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with at least one symptom questionnaire (SQ) completed after enrollment using the PROMIS platform
timeFrame: 6 months
measure: Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) physical subscale score
timeFrame: baseline, 6 months
measure: Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) mental subscale score
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Rate of SQ adherence
timeFrame: 6 months
measure: Average number of diary encounters
timeFrame: 6 months
measure: Change in overall Functional Assessment of Cancer Therapy-General (FACT-G) score
timeFrame: baseline, 6 months
measure: Symptom experience
timeFrame: 6 months
measure: Proportion of clinicians that report satisfactory use of the Noona system
timeFrame: 6 months
measure: Tabulated responses from Noona Patient Feedback questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Kavitha Ramchandran, MD
role: PRINCIPAL_INVESTIGATOR
References: