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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05112198
• Other study ID #: IRB-38423
• Secondary ID: PS0002
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 204
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life

Intervention

Device:
• Use of Noona web- based symptom tracking tool
Noona patient reported outcome (PRO) platform tool that summarizes symptoms and distress

Locations

Country	Name	City	State
United States	Stanford Cancer Institute	Palo Alto	California
United States	UCSF Helen Diller Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with at least one symptom questionnaire (SQ) completed after enrollment using the PROMIS platform		6 months
Primary	Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) physical subscale score	Scores goes from (1-5). 5=Excellent and 1=Poor	baseline, 6 months
Primary	Change in PROMIS-G (Patient-Reported Outcomes Measurement Information System-Global) mental subscale score	Scores goes from (1-5). 5=Excellent and 1=Poor	baseline, 6 months
Secondary	Rate of SQ adherence	Rate of SQ adherence is defined as completing at least 70% of requested SQs	6 months
Secondary	Average number of diary encounters	A Noona system log in is recorded as a diary encounter	6 months
Secondary	Change in overall Functional Assessment of Cancer Therapy-General (FACT-G) score	Scores goes from (0-4). 4=Very Much and 0=Not at all	baseline, 6 months
Secondary	Symptom experience	Number of patient-reported symptoms by type and severity	6 months
Secondary	Proportion of clinicians that report satisfactory use of the Noona system		6 months
Secondary	Tabulated responses from Noona Patient Feedback questionnaire	Questions include patient response to question about getting started with the Noona system and ease of use and user experience.	6 months