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

Cancer Clinical Trial

— TIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134636
• Other study ID #: UPCC 16921
• Status: Completed
• Phase: N/A
• Start date: December 6, 2021
• Est. completion date: December 12, 2022

Study information

• Verified date: July 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Patient Empowerment
• Solid Tumor
• Telemedicine

Intervention

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.

Locations

Country	Name	City	State
United States	Perelman Center for Advanced Care	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare time	Time spent commuting to, waiting for, and receiving healthcare over a 3 month follow up period.	3 months
Secondary	Total wait time	Time spent waiting for healthcare over a 3 month follow up period.	3 months
Secondary	Total number of hospitalization/emergency department encounters	Total number of hospitalizations and emergency department encounters over a 3 month follow up.	3 months
Secondary	Patient satisfaction as assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)	The Patient Satisfaction Questionnaire Short Form (PSQ-18)	3 months
Secondary	Provider satisfaction as assessed by Net-Promoter Score	Net-Promoter Score	3 months
Secondary	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