Cancer, Patient Empowerment, Solid Tumor, Telemedicine
Conditions
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.
Interventions
OTHERText 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.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Time | 3 months | Time spent commuting to, waiting for, and receiving healthcare over a 3 month follow up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Wait Time | 3 months | Time spent waiting for healthcare over a 3 month follow up period. |
| Total Number of Hospitalization/Emergency Department Encounters | 3 months | Total number of hospitalizations and emergency department encounters over a 3 month follow up. |
| Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | 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. |
| Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Treatment Arm | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 67 years | 69 years | 67 years |
| Distance in Miles from Cancer Center 0-19.3 miles | 6 participants | 3 participants | 9 participants |
| Distance in Miles from Cancer Center 19.31-33.13 miles | 4 participants | 5 participants | 9 participants |
| Distance in Miles from Cancer Center 33.14-49.38 miles | 4 participants | 5 participants | 9 participants |
| Distance in Miles from Cancer Center 49.39-150 miles | 4 participants | 4 participants | 8 participants |
| Distance in Miles from Cancer Center Missing | 1 participants | 4 participants | 5 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 20 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 5 Participants |
| Highest Education Associate degree | 2 Participants | 1 Participants | 3 Participants |
| Highest Education Bachelor's degree | 3 Participants | 5 Participants | 8 Participants |
| Highest Education High school diploma/GED | 3 Participants | 6 Participants | 9 Participants |
| Highest Education Master's degree | 3 Participants | 5 Participants | 8 Participants |
| Highest Education Some college | 3 Participants | 2 Participants | 5 Participants |
| Highest Education Some graduate school | 1 Participants | 1 Participants | 2 Participants |
| Highest Education Technical or trade school | 3 Participants | 1 Participants | 4 Participants |
| Highest Education Unknown | 1 Participants | 0 Participants | 1 Participants |
| ICI Type Atezolizumab | 1 Participants | 1 Participants | 2 Participants |
| ICI Type Avelumab | 1 Participants | 1 Participants | 2 Participants |
| ICI Type Cemiplimab | 1 Participants | 0 Participants | 1 Participants |
| ICI Type Durvalumab | 1 Participants | 0 Participants | 1 Participants |
| ICI Type Nivolumab | 2 Participants | 2 Participants | 4 Participants |
| ICI Type Pembrolizumab | 13 Participants | 17 Participants | 30 Participants |
| Income $0-20,000 | 2 Participants | 2 Participants | 4 Participants |
| Income $100,001+ | 11 Participants | 5 Participants | 16 Participants |
| Income $20,001-40,000 | 2 Participants | 2 Participants | 4 Participants |
| Income $40,001-60,000 | 0 Participants | 3 Participants | 3 Participants |
| Income $60,001-80,000 | 1 Participants | 4 Participants | 5 Participants |
| Income $80,001-100,000 | 0 Participants | 2 Participants | 2 Participants |
| Income Missing | 3 Participants | 3 Participants | 6 Participants |
| Lines of Prior Therapy 0 | 12 Participants | 9 Participants | 21 Participants |
| Lines of Prior Therapy 1 | 4 Participants | 10 Participants | 14 Participants |
| Lines of Prior Therapy 2 | 0 Participants | 2 Participants | 2 Participants |
| Lines of Prior Therapy 3+ | 3 Participants | 0 Participants | 3 Participants |
| Marital Status Divorced | 1 Participants | 2 Participants | 3 Participants |
| Marital Status Married | 16 Participants | 15 Participants | 31 Participants |
| Marital Status Missing | 1 Participants | 0 Participants | 1 Participants |
| Marital Status Single | 1 Participants | 2 Participants | 3 Participants |
| Marital Status Widowed | 0 Participants | 2 Participants | 2 Participants |
| Patient-reported ECOG PS 0-1 | 12 Participants | 14 Participants | 26 Participants |
| Patient-reported ECOG PS 2+ | 4 Participants | 2 Participants | 6 Participants |
| Patient-reported ECOG PS Missing | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 14 Participants | 19 Participants | 33 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
| Tumor Stage 1 | 0 Participants | 1 Participants | 1 Participants |
| Tumor Stage 2 | 1 Participants | 0 Participants | 1 Participants |
| Tumor Stage 3 | 7 Participants | 4 Participants | 11 Participants |
| Tumor Stage 4 | 9 Participants | 16 Participants | 25 Participants |
| Tumor Stage Missing | 2 Participants | 0 Participants | 2 Participants |
| Tumor Type Gastrointestinal | 0 Participants | 1 Participants | 1 Participants |
| Tumor Type Genitourinary | 10 Participants | 14 Participants | 24 Participants |
| Tumor Type Head and Neck | 2 Participants | 0 Participants | 2 Participants |
| Tumor Type Other | 0 Participants | 1 Participants | 1 Participants |
| Tumor Type Skin | 3 Participants | 0 Participants | 3 Participants |
| Tumor Type Thoracic | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 0 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
Primary
Healthcare Time
Time spent commuting to, waiting for, and receiving healthcare over a 3 month follow up period.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Healthcare Time | 265.97 minutes | Standard Deviation 77.6 |
| Usual Care | Healthcare Time | 339.54 minutes | Standard Deviation 108.29 |
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: * 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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) | Physical well-being (0-28) | 23.21 units on a scale | Standard Deviation 5.31 |
| Treatment Arm | Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) | Social/family well-being (0-28) | 22.48 units on a scale | Standard Deviation 5.04 |
| Treatment Arm | Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) | Emotional well-being (0-24) | 17.66 units on a scale | Standard Deviation 5.45 |
| Treatment Arm | Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) | Functional well-being (0-28) | 17.19 units on a scale | Standard Deviation 9 |
| Usual Care | Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) | Functional well-being (0-28) | 21 units on a scale | Standard Deviation 4.24 |
| Usual Care | Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) | Physical well-being (0-28) | 23.4 units on a scale | Standard Deviation 4.27 |
| Usual Care | Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) | Emotional well-being (0-24) | 20.6 units on a scale | Standard Deviation 3 |
| Usual Care | Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) | Social/family well-being (0-28) | 25.71 units on a scale | Standard Deviation 5.39 |
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). * 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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Arm | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Interpersonal Manner (0-5) | 4.19 units on a scale of 5 | Standard Deviation 0.77 |
| Treatment Arm | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Financial Aspects (0-5) | 3.88 units on a scale of 5 | Standard Deviation 0.87 |
| Treatment Arm | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Technical Quality (0-5) | 4.42 units on a scale of 5 | Standard Deviation 0.77 |
| Treatment Arm | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Time Spent with Doctor (0-5) | 4.38 units on a scale of 5 | Standard Deviation 0.59 |
| Treatment Arm | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Communication (0-5) | 4.25 units on a scale of 5 | Standard Deviation 0.86 |
| Treatment Arm | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Accessibility and Convenience (0-5) | 3.72 units on a scale of 5 | Standard Deviation 0.58 |
| Treatment Arm | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | General Satisfaction (0-5) | 4.34 units on a scale of 5 | Standard Deviation 0.59 |
| Usual Care | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Accessibility and Convenience (0-5) | 3.93 units on a scale of 5 | Standard Deviation 0.58 |
| Usual Care | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | General Satisfaction (0-5) | 4.5 units on a scale of 5 | Standard Deviation 0.77 |
| Usual Care | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Technical Quality (0-5) | 4.48 units on a scale of 5 | Standard Deviation 0.58 |
| Usual Care | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Interpersonal Manner (0-5) | 4.64 units on a scale of 5 | Standard Deviation 0.41 |
| Usual Care | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Communication (0-5) | 4.61 units on a scale of 5 | Standard Deviation 0.45 |
| Usual Care | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Financial Aspects (0-5) | 3.82 units on a scale of 5 | Standard Deviation 0.77 |
| Usual Care | Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) | Time Spent with Doctor (0-5) | 4.32 units on a scale of 5 | Standard Deviation 0.64 |
Secondary
Total Number of Hospitalization/Emergency Department Encounters
Total number of hospitalizations and emergency department encounters over a 3 month follow up.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Total Number of Hospitalization/Emergency Department Encounters | 3 admissions |
| Usual Care | Total Number of Hospitalization/Emergency Department Encounters | 2 admissions |
Secondary
Total Wait Time
Time spent waiting for healthcare over a 3 month follow up period.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Total Wait Time | 124.79 minutes | Standard Deviation 44.35 |
| Usual Care | Total Wait Time | 154.71 minutes | Standard Deviation 72.34 |