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

Not Applicable

Completed

• Conditions: Solid Tumor; Patient Empowerment; Cancer; Telemedicine
• Interventions: Other: Text triage

• Registration Number: NCT05134636
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-26
• Study Start: 2021-12-06
• Primary Completion: 2022-12-12
• Study Completion: 2022-12-12
• Results First Submitted: 2024-03-19
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Results First Posted: 2025-03-06
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Text triage	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.

Primary Outcome Measures

Name	Time	Method
Healthcare Time	3 months	Time spent commuting to, waiting for, and receiving healthcare over a 3 month follow up period.

Secondary Outcome Measures

Name	Time	Method
Total Wait Time	3 months	Time spent waiting for healthcare over a 3 month follow up period.
Total Number of Hospitalization/Emergency Department Encounters	3 months	Total number of hospitalizations and emergency department encounters over a 3 month follow up.
Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)	3 months	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.
Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)	3 months	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.

Trial Locations

Locations (1)

Perelman Center for Advanced Care; 🇺🇸 Philadelphia, Pennsylvania, United States