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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-12414 | Other Identifier | National Cancer Institute Clinical Trials Reporting Program |
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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
| Noona Healthcare | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noona web-based symptom tracking tool | Experimental | 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. |
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| Usual Care | No Intervention | Participants will receive the standard of care for their disease |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of Noona web- based symptom tracking tool | Other | Noona patient reported outcome (PRO) platform tool that summarizes symptoms and distress |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Scores goes from (1-5). 5=Excellent and 1=Poor | baseline, 6 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of SQ adherence | Rate of SQ adherence is defined as completing at least 70% of requested SQs | 6 months |
| Average number of diary encounters | A Noona system log in is recorded as a diary encounter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kavitha Ramchandran, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Palo Alto | California | 94305 | United States | ||
| UCSF Helen Diller Medical Center |
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| 6 months |
| 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 |
| Symptom experience | Number of patient-reported symptoms by type and severity | 6 months |
| Proportion of clinicians that report satisfactory use of the Noona system | 6 months |
| 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 |
| San Francisco |
| California |
| 94115 |
| United States |