Text-based Intervention to Minimize the Time Burden of Routine Cancer Care

Study Overview
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Brief Summary
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The primary objective is to test whether a text-based e-triage can safely minimize the time associated with routine cancer care by identifying patients who can proceed directly to their immunotherapy infusion without a preceding in-person office assessment.

Official Title
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Text-based Intervention to Minimize the Time Burden of Routine Cancer Care

Conditions
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Cancer, Solid Tumor, Patient Empowerment, Telemedicine

Intervention / Treatment
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* Other: Text triage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age Initiating singe agent PDL-1/PD-1 targeted immune checkpoint blockade for any solid malignancy at Penn's Abramson Cancer Center Access to a mobile phone with texting capabilities ECOG performance status less than or equal to 2 Exclusion Criteria: Non-English speaking Unable to perform informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>For patients in the intervention arm, symptoms and laboratory results will be assessed using the text-based e-triage 96 hours prior to their intended infusion date. The e-triage will consist of a standardized questionnaire and algorithm to evaluate symptoms and laboratory values. Patients with acceptable labs and minimal or no symptoms can opt to proceed directly to their immunotherapy infusion without an in-person office assessment. | Other: Text triage<br>* The e-triage will consist of 16 questions, modified from the validated NCI Pro-CTCAETM, which will be sent to patients via WaytoHealth©'s two-way texting system 96 hours prior to their scheduled immunotherapy infusion. Questions will pertain to common or emergent immune related adverse events as defined by the NCCN guidelines and two senior disease experts. Patients will be prompted via text to measure the presence and severity of symptoms over the week prior. A final question will be included to capture any additional symptoms patients wish to disclose.<br>|
| No Intervention: Usual Care<br>Patients in the usual care arm will receive standard of care symptom monitoring including an in-person office assessment prior to their scheduled immunotherapy infusion. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare time | Time spent commuting to, waiting for, and receiving healthcare over a 3 month follow up period. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total wait time | Time spent waiting for healthcare over a 3 month follow up period. | 3 months | 
| Total number of hospitalization/emergency department encounters | Total number of hospitalizations and emergency department encounters over a 3 month follow up. | 3 months | 
| Patient satisfaction as assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | The Patient Satisfaction Questionnaire Short Form (PSQ-18) | 3 months | 
| Provider satisfaction as assessed by Net-Promoter Score | Net-Promoter Score | 3 months | 
| Health related quality of life as assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) | The Functional Assessment of Cancer Therapy-General (FACT-G) | 3 months |