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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Time | Time spent commuting to, waiting for, and receiving healthcare over a 3 month follow up period. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Wait Time | Time spent waiting for healthcare over a 3 month follow up period. | 3 months |
| Total Number of Hospitalization/Emergency Department Encounters | Total number of hospitalizations and emergency department encounters over a 3 month follow up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Bange, MD | Fellow | Principal Investigator |
| Ronac Mamtani, MD, MSCE | Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perelman Center for Advanced Care | Philadelphia | Pennsylvania | 19104 | United States |
Individual participant data that underlie the results reported in publication, after deidentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication.
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.
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Run-in period during which patients were sent a preliminary text message asking them to confirm study participation. 11 patients did not respond to this enrollment text.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Healthcare Time | Time spent commuting to, waiting for, and receiving healthcare over a 3 month follow up period. | Posted | Mean | Standard Deviation | minutes | 3 months |
|
3 months
Minimal risk study - adverse events as defined did not result from our intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronac Mamtani | University of Pennsylvania | 215-662-7606 | ronac.mamtani@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2022 | Mar 19, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2022 | Dec 9, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
| 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).
After noting score values for each individual response, items are then averaged for each subscale to gain a subscale score. | 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:
| 3 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Distance in Miles from Cancer Center | Number | participants |
|
| Marital Status | Count of Participants | Participants |
|
| Highest Education | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| Tumor Stage | Cancer staging describes the severity of an individual's cancer based on the magnitude of the original (primary) tumor as well as on the extent cancer has spread in the body, and is determined by the patient's primary oncologist, with 1 being least severe. | Count of Participants | Participants |
|
| Tumor Type | Count of Participants | Participants |
|
| ICI Type | Count of Participants | Participants |
|
| Lines of Prior Therapy | Count of Participants | Participants |
|
| Patient-reported ECOG PS | The ECOG Performance Status Scale describes a patient's self-reported level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). 0 Fully active, able to carry on all pre-disease performance without restriction
| Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | Total Wait Time | Time spent waiting for healthcare over a 3 month follow up period. | Posted | Mean | Standard Deviation | minutes | 3 months |
|
|
|
| Secondary | Total Number of Hospitalization/Emergency Department Encounters | Total number of hospitalizations and emergency department encounters over a 3 month follow up. | Posted | Number | admissions | 3 months |
|
|
|
| Secondary | 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).
After noting score values for each individual response, items are then averaged for each subscale to gain a subscale score. | Posted | Mean | Standard Deviation | units on a scale of 5 | 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) is a 27-item questionnaire comprised of four subscales to measure health-related quality of life:
| Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
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| Interpersonal Manner (0-5) |
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| Communication (0-5) |
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| Financial Aspects (0-5) |
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| Time Spent with Doctor (0-5) |
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| Accessibility and Convenience (0-5) |
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| Emotional well-being (0-24) |
|
| Functional well-being (0-28) |
|