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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Solid Tumor; Telemedicine; Patient Empowerment
• Intervention / Treatment: Other: Text triage

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Perelman Center for Advanced Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 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; 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.
No Intervention: Usual Care; 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?

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) is a self-reported measure capturing satisfaction with medical care across 7 dimensions, all subscales (no total).; General Satisfaction (3&17) - higher scores represent greater satisfaction; Technical Quality (2, 4, 6, 14) -higher scores represent better technical quality; Interpersonal Manner (10&11) - higher scores represent better interpersonal manner; Communication (1&13) - higher scores represent better communication; Financial Aspects (5&7) - higher scores represent better financial aspects; Time Spent with Doctor (12&15) - higher scores represent better time spent w/ dr; Accessibility and Convenience (8, 9, 16, 18) - higher scores represent more accessibility Reverse scoring takes place for items 1, 2, 3, 5, 6, 8, 11, 15, and 18 such that a response of 1 has a score value of 5, and so on. After noting score values for each individual response, items are then averaged for each subscale to gain a subscale 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) is a 27-item questionnaire comprised of four subscales to measure health-related quality of life: physical well-being (PWB; 7-items, score range 0-28), higher score = better PWB; social/family well-being (SWB; 7-items, score range 0-28), higher score = worse SWB; emotional well-being (EWB; 6-items, score range 0-24), higher score = better EWB except item 2 where higher score = worse EWB; functional well-being (FWB; 7-items, score range 0-28), higher score = worse FWB All questions in the FACT-G use a 5-point rating scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Within a subscale, response are reversed for those where higher score = worse well-being, and then averaged for the scale score.	3 months

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Erin Bange, MD, Fellow; Principal Investigator: Ronac Mamtani, MD, MSCE, Faculty

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: UPCC 16921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in publication, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: IPD will be shared with researchers who provide a methodologically sound proposal, for the purpose of achieving aims in the approved proposal. Proposals should be directed to bangee@mskcc.org and ronac.mamtani@pennmedicine.upenn.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No