NCT05812274 — Apricity CARE to Improve ICI Outcomes of Ethnic/Racial Minority NSCLC Patients · CancerIndex
Clinical trial · Interventional
Apricity CARE to Improve ICI Outcomes of Ethnic/Racial Minority NSCLC Patients
A Phase IV Study of Apricity C.A.R.E. Program for Cancer Adverse Events Rapid Evaluation to Improve Treatment Outcomes of Ethnic/Racial Minority Non-small Cell Lung Cancer (NSCLC) Patients Receiving Immunotherapy
The purpose of this trial is to study the effectiveness of the AprictyRxTM care service to improve treatment outcomes of ethnic/racial minority N.S.C.L.C. patients receiving standard of care immunotherapy, and reduce the frequency of healthcare system interactions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Apricity C.A.R.E. Program for Cancer Adverse events Rapid Evaluation
Other
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UNRESOLVED
Design
Arms and outcomes
Arms (2)
type
EXPERIMENTAL
label
Intervention Arm
description
Participants are provided with ApricityRx digital solution with pulse oximeters and 24/7 C.A.R.E. (Cancer Adverse event Rapid Evaluation) to monitor and capture ePRO, identify onset or progression of symptoms verified by nurse triage, trigger intervention by the study team.
interventionNames
Other: Apricity C.A.R.E. Program for Cancer Adverse events Rapid Evaluation
type
NO_INTERVENTION
label
Control Arm
description
Clinicians will monitor NSCLC patients on ICIs for irAEs as a standard of care using routine practices.
Primary outcomes (2)
measure
Mean Likert-type scale score
timeFrame
2 years
description
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
Inclusion Criteria:
* Age≥ 18 years
* Confirmed NSCLC diagnosis
* Prescribed treatment with immune-checkpoint inhibitor, including in combination with chemotherapy
* Ability to understand and the willingness to sign a written informed consent document
* Self-identification as a member of an ethnic minority or underserved population.
Exclusion Criteria:
* An individual with presence of any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study.
* Patients enrolled in other interventional clinical trials at the time of screening will be excluded.
References
Publications (29)
BACKGROUNDHellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora Jimenez E, Sakai H, Albert I, Vergnenegre A, Peters S, Syrigos K, Barlesi F, Reck M, Borghaei H, Brahmer JR, O'Byrne KJ, Geese WJ, Bhagavatheeswaran P, Rabindran SK, Kasinathan RS, Nathan FE, Ramalingam SS. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019 Nov 21;381(21):2020-2031. doi: 10.1056/NEJMoa1910231. Epub 2019 Sep 28. PMID 31562796
BACKGROUNDGandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16. PMID 29658856
BACKGROUNDPaz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Salman P, Souquet PJ, De Marchi P, Martin C, Perol M, Scherpereel A, Lu S, John T, Carbone DP, Meadows-Shropshire S, Agrawal S, Oukessou A, Yan J, Reck M. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):198-211. doi: 10.1016/S1470-2045(20)30641-0. Epub 2021 Jan 18. PMID 33476593
BACKGROUNDReck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8. PMID 27718847
BACKGROUNDHerbst RS, Baas P, Kim DW, Felip E, Perez-Gracia JL, Han JY, Molina J, Kim JH, Arvis CD, Ahn MJ, Majem M, Fidler MJ, de Castro G Jr, Garrido M, Lubiniecki GM, Shentu Y, Im E, Dolled-Filhart M, Garon EB. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016 Apr 9;387(10027):1540-1550. doi: 10.1016/S0140-6736(15)01281-7. Epub 2015 Dec 19.
Two focus group discussions (FGDs), stratified on a Likert-type scale based on the frequency of utilization, to determine factors related to usage of ApricityCare app and utilization of the CARE monitoring service (Run-in phase). To assess factors related to suboptimal and optimal use of the ApricityCare app and the CARE monitoring service, collectively "the Apricity CARE program".
measure
Percent of study patients who experienced treatment delay/discontinuation
timeFrame
2 years
description
To determine the impact of the the Apricity CARE program on immunotherapy toxicity monitoring for N.S.C.L.C. patients receiving immunotherapy in a highly diverse New York City community. Immune Checkpoint Inhibitor (ICI) treatment delay or discontinuation is defined as a gap between doses of ICI beyond 60 days and/or the initiation of another cancer therapy without evidence of disease progression.
Secondary outcomes (5)
measure
Percent of study patients who experience a severe irAE (grade 3 or higher).
timeFrame
2.5 years
description
To assess the percent of study patients who experience a severe irAE (grade 3 or higher) while on study. Information about individual treatment toxicities (i.e., type, frequency) will be obtained and recorded from the ApricityRxTM platform and patient's clinical note. Toxicity grade will be assigned using the NCI CTCAE v5.0 and tallied.
measure
Time to irAE management
timeFrame
2.5 years
description
To quantify time to irAE management with ICI. This will be defined as the time from the onset of irAE to time of active intervention (i.e., change in administration schedule, new prescription of supportive medication, telephone counseling about symptoms, unscheduled visits or referrals). Information will be obtained and recorded from the ApricityRxTM platform and patient's clinical note, and tallied. Unit measured in days.
measure
Time to treatment discontinuation with ICI
timeFrame
2.5 years
description
To quantify time to irAE management with ICI. This will be determined as starting date of ICI to date of the last dose of ICI for any reason specified by patient's EMR. Information will be obtained and recorded from the ApricityRxTM platform and patient's clinical note, and tallied. Unit measured in days.
measure
Number of interactions with the care team and utilization
timeFrame
2.5 years
description
This will be quantified as the number of clinical interactions between patients and providers from the patient's EMR and will include telephone encounters, unscheduled clinic visits, ED visits, hospital admissions - total will be tallied.
measure
Number of interviews/surveys completed
timeFrame
2.5 years
description
Patient and provider experience will be assessed with focus group discussions (FGDs), semi-structured interviews, and surveys
BACKGROUNDHerbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Ozguroglu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. doi: 10.1056/NEJMoa1917346. PMID 32997907
BACKGROUNDWest H, McCleod M, Hussein M, Morabito A, Rittmeyer A, Conter HJ, Kopp HG, Daniel D, McCune S, Mekhail T, Zer A, Reinmuth N, Sadiq A, Sandler A, Lin W, Ochi Lohmann T, Archer V, Wang L, Kowanetz M, Cappuzzo F. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):924-937. doi: 10.1016/S1470-2045(19)30167-6. Epub 2019 May 20. PMID 31122901
BACKGROUNDRittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13. PMID 27979383
BACKGROUNDAntonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8. PMID 28885881
BACKGROUNDBorghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27. PMID 26412456
BACKGROUNDHaslam A, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs. JAMA Netw Open. 2019 May 3;2(5):e192535. doi: 10.1001/jamanetworkopen.2019.2535. PMID 31050774
BACKGROUNDPillai RN, Behera M, Owonikoko TK, Kamphorst AO, Pakkala S, Belani CP, Khuri FR, Ahmed R, Ramalingam SS. Comparison of the toxicity profile of PD-1 versus PD-L1 inhibitors in non-small cell lung cancer: A systematic analysis of the literature. Cancer. 2018 Jan 15;124(2):271-277. doi: 10.1002/cncr.31043. Epub 2017 Sep 28. PMID 28960263
BACKGROUNDXing P, Zhang F, Wang G, Xu Y, Li C, Wang S, Guo Y, Cai S, Wang Y, Li J. Incidence rates of immune-related adverse events and their correlation with response in advanced solid tumours treated with NIVO or NIVO+IPI: a systematic review and meta-analysis. J Immunother Cancer. 2019 Dec 4;7(1):341. doi: 10.1186/s40425-019-0779-6. PMID 31801636
BACKGROUNDReynolds KL, Cohen JV, Ryan DP, Hochberg EP, Dougan M, Thomas M, Guidon A, Channick C, Chen ST, Schoenfeld S, Sise M, Leaf R, Neilan TG, Chu JN, Hur C, Murciano-Goroff Y, Villani AC, Nasrallah M, Sullivan RJ, Bardia A. Severe immune-related adverse effects (irAE) requiring hospital admission in patients treated with immune checkpoint inhibitors for advanced malignancy: Temporal trends and clinical significance. Journal of Clinical Oncology. 2018;36(15_suppl):3096-. doi: 10.1200/JCO.2018.36.15_suppl.3096.
BACKGROUNDZhou X, Yao Z, Yang H, Liang N, Zhang X, Zhang F. Are immune-related adverse events associated with the efficacy of immune checkpoint inhibitors in patients with cancer? A systematic review and meta-analysis. BMC Med. 2020 Apr 20;18(1):87. doi: 10.1186/s12916-020-01549-2. PMID 32306958
BACKGROUNDDas S, Johnson DB. Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors. J Immunother Cancer. 2019 Nov 15;7(1):306. doi: 10.1186/s40425-019-0805-8. PMID 31730012
BACKGROUNDShankar B, Zhang J, Naqash AR, Forde PM, Feliciano JL, Marrone KA, Ettinger DS, Hann CL, Brahmer JR, Ricciuti B, Owen D, Toi Y, Walker P, Otterson GA, Patel SH, Sugawara S, Naidoo J. Multisystem Immune-Related Adverse Events Associated With Immune Checkpoint Inhibitors for Treatment of Non-Small Cell Lung Cancer. JAMA Oncol. 2020 Dec 1;6(12):1952-1956. doi: 10.1001/jamaoncol.2020.5012. PMID 33119034
BACKGROUNDSun X, Roudi R, Dai T, Chen S, Fan B, Li H, Zhou Y, Zhou M, Zhu B, Yin C, Li B, Li X. Immune-related adverse events associated with programmed cell death protein-1 and programmed cell death ligand 1 inhibitors for non-small cell lung cancer: a PRISMA systematic review and meta-analysis. BMC Cancer. 2019 Jun 10;19(1):558. doi: 10.1186/s12885-019-5701-6. PMID 31182061
BACKGROUNDMartins F, Sofiya L, Sykiotis GP, Lamine F, Maillard M, Fraga M, Shabafrouz K, Ribi C, Cairoli A, Guex-Crosier Y, Kuntzer T, Michielin O, Peters S, Coukos G, Spertini F, Thompson JA, Obeid M. Adverse effects of immune-checkpoint inhibitors: epidemiology, management and surveillance. Nat Rev Clin Oncol. 2019 Sep;16(9):563-580. doi: 10.1038/s41571-019-0218-0. PMID 31092901
BACKGROUNDOsarogiagbon RU, Sineshaw HM, Unger JM, Acuna-Villaorduna A, Goel S. Immune-Based Cancer Treatment: Addressing Disparities in Access and Outcomes. Am Soc Clin Oncol Educ Book. 2021 Mar;41:1-13. doi: 10.1200/EDBK_323523. PMID 33830825
BACKGROUNDBasch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7. PMID 26644527
BACKGROUNDKotronoulas G, Kearney N, Maguire R, Harrow A, Di Domenico D, Croy S, MacGillivray S. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol. 2014 May 10;32(14):1480-501. doi: 10.1200/JCO.2013.53.5948. Epub 2014 Apr 7. PMID 24711559
BACKGROUNDDenis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085. PMID 30667494
BACKGROUNDUS Department of Health and Human Services FaDA, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for industry: core patient-reported outcomes in cancer clinical trials. 2021 [cited 2021 6 August]. Available from: https://www.fda.gov/media/149994/download.
BACKGROUNDSafa H, Tamil M, Spiess PE, Manley B, Pow-Sang J, Gilbert SM, Safa F, Gonzalez BD, Oswald LB, Semaan A, Diab A, Chahoud J. Patient-Reported Outcomes in Clinical Trials Leading to Cancer Immunotherapy Drug Approvals From 2011 to 2018: A Systematic Review. J Natl Cancer Inst. 2021 May 4;113(5):532-542. doi: 10.1093/jnci/djaa174. PMID 33146385
BACKGROUNDSisodia RC, Rodriguez JA, Sequist TD. Digital disparities: lessons learned from a patient reported outcomes program during the COVID-19 pandemic. J Am Med Inform Assoc. 2021 Sep 18;28(10):2265-2268. doi: 10.1093/jamia/ocab138. PMID 34244760
BACKGROUNDGadgeel SM. Patient-Reported Outcomes in the Era of Immunotherapy Trials. J Thorac Oncol. 2021 Apr;16(4):516-518. doi: 10.1016/j.jtho.2021.02.014. No abstract available. PMID 33781441
BACKGROUNDWhereWeLiveNYC. Explore Data- Where New Yokers Live 2018 [cited 2021 6 August]. Available from: https://wherewelive.cityofnewyork.us/explore-data/where-new-yorkers-live/.