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OpenTrials
Completed

NCT Number: NCT05134636

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

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.

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Key information

Conditions

Cancer Behavior Health Behavior Neoplasms Patient Acceptance of Health Care Patient Empowerment Patient Participation Solid Tumor Telemedicine Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perelman Center for Advanced Care

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Healthcare Time

    Time frame: 3 months

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

Secondary outcomes

  1. Total Wait Time

    Time frame: 3 months

    Time spent waiting for healthcare over a 3 month follow up period.

  2. Total Number of Hospitalization/Emergency Department Encounters

    Time frame: 3 months

    Total number of hospitalizations and emergency department encounters over a 3 month follow up.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Acronym: TIME

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2021
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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