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

NCT05134636 | Completed Results

• 1 other identifier: UPCC 16921
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Solid Tumor; Patient Empowerment; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Healthcare Time

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

  3 months

Secondary Outcomes (4)

• Total Wait Time

  3 months

• Total Number of Hospitalization/Emergency Department Encounters

  3 months

• Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)

  3 months

• Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)

  3 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Text triage OTHER

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• Unable to perform informed consent

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Perelman Center for Advanced Care

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Ronac Mamtani
• Organization: University of Pennsylvania

ronac.mamtani@pennmedicine.upenn.edu

215-662-7606

Study Officials

• Erin Bange, MD

  Fellow

  PRINCIPAL INVESTIGATOR

• Ronac Mamtani, MD, MSCE

  Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 26, 2021
• Study Start: December 6, 2021
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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.

Locations

US (1)