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

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05134636

Collaborator

(none)

176

Enrollment

Location

Arms

6.8

Anticipated Duration (Months)

25.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Solid Tumor Patient Empowerment Telemedicine	Other: Text triage	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Dec 6, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Provider satisfaction as assessed by Net-Promoter Score [3 months]
Net-Promoter 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Perelman Center for Advanced Care	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator: Erin Bange, MD, Fellow
Principal Investigator: Ronac Mamtani, MD, MSCE, Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT05134636

Other Study ID Numbers:

UPCC 16921

First Posted:

Nov 26, 2021

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 31, 2022