CancerTIMENCT05134636
Text-based Intervention to Minimize the Time Burden of Routine Cancer Care
A study testing Text triage in people with Cancer and Solid Tumor, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Patient Empowerment
- What is being tested?
- Text triage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to 12 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English speaking
- Unable to perform informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center for Advanced Care
Philadelphia, Pennsylvania, 19104
About this study
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
- Being tested
- Text triage
- Medical subject headings
- Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text triageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare Time
Time spent commuting to, waiting for, and receiving healthcare over a 3 month follow up period.
Measured: 3 months
Secondary outcomes (4)
Total Wait Time
Time spent waiting for healthcare over a 3 month follow up period.
Measured: 3 months
Total Number of Hospitalization/Emergency Department Encounters
Total number of hospitalizations and emergency department encounters over a 3 month follow up.
Measured: 3 months
Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
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.
Measured: 3 months
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) 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start6 Dec 2021
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Bange, MD, Principal investigator, FellowRonac Mamtani, MD, MSCE, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134636
- Sponsor's protocol ID
- UPCC 16921
- Acronym
- TIME
- Status last verified
- Mar 2025
- First submitted
- 15 Nov 2021
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publication, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text-based Intervention to Minimize the Time Burden of Routine Cancer Care
- ClinicalTrials.gov ID
- NCT05134636
- Acronym / sponsor ID
- TIME / UPCC 16921
- Conditions
- Cancer, Solid Tumor, Patient Empowerment, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Posted 6 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: Text triageFor 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Non-English speaking
- Unable to perform informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text triageThe 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. | Other | Treatment Arm |
Primary outcome
Healthcare Time
Time frame: 3 months
Time spent commuting to, waiting for, and receiving healthcare over a 3 month follow up period.
4 secondary outcomes
Total Wait Time
Time frame: 3 months
Total Number of Hospitalization/Emergency Department Encounters
Time frame: 3 months
Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Time frame: 3 months
Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publication, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Bange, MD principal investigator
Fellow
Ronac Mamtani, MD, MSCE principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text triage in people with Cancer and Solid Tumor, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare Time (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.