Tobacco Assessment in Actively Accruing National Cancer Institute Cooperative Group Program Clinical Trials

Purpose Substantial evidence suggests that tobacco use has adverse effects on cancer treatment outcomes; however, routine assessment of tobacco use has not been fully incorporated into standard clinical oncology practice. The purpose of this study was to evaluate tobacco use assessment in patients enrolled onto actively accruing cancer clinical trials. Methods Protocols and forms for 155 actively accruing trials in the National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program were evaluated for tobacco use assessment at enrollment and follow-up by using a structured coding instrument. Results Of the 155 clinical trials reviewed, 45 (29%) assessed any form of tobacco use at enrollment, but only 34 (21.9%) assessed current cigarette use. Only seven trials (4.5%) assessed any form of tobacco use during follow-up. Secondhand smoke exposure was captured in 2.6% of trials at enrollment and 0.6% during follow-up. None of the trials assessed nicotine dependence or interest in quitting at any point during enrollment or treatment. Tobacco status assessment was higher in lung/head and neck trials as well as phase III trials, but there was no difference according to year of starting accrual or cooperative group. Conclusion Most actively accruing cooperative group clinical trials do not assess tobacco use, and there is no observable trend in improvement over the past 8 years. Failure to incorporate standardized tobacco assessments into NCI-funded Cooperative Group Clinical Trials will limit the ability to provide evidence-based cessation support and will limit the ability to accurately understand the precise effect of tobacco use on cancer treatment outcomes.

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Reporting of tobacco use and impact on outcomes in cancer cooperative group clinical trials: A systematic scoping review.

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.40 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 40-40

Author(s):

Lawson Eng ◽

Janette Brual ◽

Ahsas Nagee ◽

Spencer Mok ◽

Rouhi Fazelzad ◽

...

Keyword(s):

Clinical Trials ◽

Head And Neck ◽

Tobacco Use ◽

Phase Ii ◽

Scoping Review ◽

Phase Iii ◽

Significant Heterogeneity ◽

Cooperative Group ◽

The Impact

40 Background: Continued smoking after a diagnosis of cancer negatively impacts cancer outcomes but the impact of tobacco on many innovative treatments has not yet been well established. Collecting and evaluating tobacco use in cancer clinical trials may advance understanding of the consequences of tobacco use on specific treatment modalities. We performed a systematic scoping review of the frequency of reporting and analysis of tobacco use in clinical trials run by cancer cooperative clinical trial groups. Methods: A comprehensive literature search was conducted to identify cancer cooperative group clinical trials published from January 2017 to October 2019 using Medline, Epub Ahead of Print and In-Process & Other Non-Indexed Citations, Embase, Cochrane Central Register of Controlled Trials using OvidSP. Eligible studies evaluated either systemic and/or radiation therapies, involved at least one cancer cooperative group, included > 100 adult patients and reported on at least one primary or secondary endpoint, which included overall survival (OS), disease/progression-free survival (DFS/PFS), response rates, toxicities/adverse events, or quality of life (QoL). Secondary analyses of previously published trials were excluded. Results: Among 14843 identified studies, 91 studies representing 90 trials met inclusion criteria. 24% were phase II trials, 2% phase II/III and 74% phase III. Trial start dates ranged from 1995-2015 with most (29%) between 2007-2008; median trial sample size was 406 (range: 100-4994); 86% involved systematic therapy, 35% involved radiation; 14% were lung and 5% were head and neck trials. 51% of trials had a curative intent, 33% were palliative and 16% involved hematologic cancers. 74 studies reported on OS, 73 DFS/PFS, and 88 toxicity/QoL. 19 studies reported baseline tobacco use information, while two reported collecting follow-up tobacco use. Of those collecting baseline tobacco use, only 7 reported any analysis of the impact of tobacco on clinical outcomes. There was significant heterogeneity in the reporting of baseline tobacco use: 5 reported never/ever status, 10 reported never/ex-smoker/current smoker status; 4 reported some measure of smoking intensity; none reported on verifying smoking status or second hand smoke exposure. Trials of tobacco related (lung and head and neck) cancers were more likely to report baseline tobacco use compared to non-tobacco related cancers (83% vs 6% p < 0.001). Conclusions: Few cancer cooperative group clinical trials report and analyze trial participants’ baseline tobacco use, and even fewer collect follow up information. Significant heterogeneity exists in reporting tobacco use. Routine standardized collection and reporting of tobacco use, both at baseline and follow up in clinical trials, should be implemented to enable investigators to evaluate the clinical impact of tobacco use on new cancer therapies.

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Factors Affecting Workload of Cancer Clinical Trials: Results of a Multicenter Study of the National Cancer Institute of Canada Clinical Trials Group

Journal of Clinical Oncology ◽

10.1200/jco.2002.20.2.545 ◽

2002 ◽

Vol 20 (2) ◽

pp. 545-556 ◽

Cited By ~ 34

Author(s):

Kathyrn Roche ◽

Nancy Paul ◽

Bobbi Smuck ◽

Marlo Whitehead ◽

Benny Zee ◽

...

Keyword(s):

Clinical Trials ◽

Data Collection ◽

Cancer Treatment ◽

Multicenter Study ◽

National Cancer Institute ◽

Phase Iii ◽

Study Phase ◽

Factors Affecting ◽

Clinical Research Associates

PURPOSE: Increasingly, cancer treatment centers need to be able to estimate specific costs and resources associated with clinical trials. Because the time requirements of trial coordination and data collection are not well known, the Clinical Research Associates (CRA) Committee of the National Cancer Institute of Canada Clinical Trials Group carried out a multicenter study to measure trials’ task times and evaluate the effects of certain factors. METHODS: A data collection instrument was designed and validated before its implementation in the study. Eighty-three CRAs from 24 cancer treatment institutions across Canada collected timing observations of 41 tasks (156 subtasks). Information from all stages of trials activity (protocol management, eligibility and entry, treatment, and follow-up and final stage) was obtained, from initial negotiations to follow-up after study closure. RESULTS: After controlling for stage, phase and sponsor were found to be significant independent factors. Analysis within the stages showed similar patterns. New drug inclusion as a factor was confounded with phase. Industry-sponsored studies had significantly higher overall mean times than did local and cooperative group studies. Early-phase studies required more time than did phase III trials. External sponsorship of any kind increased CRA time more than that necessary for locally coordinated studies, except during the protocol management stage. The burden of a phase I study increased to greater than average once underway and accruing patients. CONCLUSION: Our data demonstrated that sponsor and study phase are important factors to be taken into consideration when estimating clinical trial costs and resource use.

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Effect of self-regulatory behaviour change techniques and predictors of physical activity maintenance in cancer survivors: a 12-month follow-up of the Phys-Can RCT

BMC Cancer ◽

10.1186/s12885-021-08996-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Anne-Sophie Mazzoni ◽

Hannah L. Brooke ◽

Sveinung Berntsen ◽

Karin Nordin ◽

Ingrid Demmelmaier

Keyword(s):

Physical Activity ◽

Cancer Survivors ◽

Cancer Treatment ◽

Tobacco Use ◽

Exercise Intervention ◽

Behaviour Change Techniques ◽

Exercise Motivation ◽

History Of

Abstract Background Current knowledge about the promotion of long-term physical activity (PA) maintenance in cancer survivors is limited. The aims of this study were to 1) determine the effect of self-regulatory BCTs on long-term PA maintenance, and 2) identify predictors of long-term PA maintenance in cancer survivors 12 months after participating in a six-month exercise intervention during cancer treatment. Methods In a multicentre study with a 2 × 2 factorial design, the Phys-Can RCT, 577 participants with curable breast, colorectal or prostate cancer and starting their cancer treatment, were randomized to high intensity exercise with or without self-regulatory behaviour change techniques (BCTs; e.g. goal-setting and self-monitoring) or low-to-moderate intensity exercise with or without self-regulatory BCTs. Participants’ level of PA was assessed at the end of the exercise intervention and 12 months later (i.e. 12-month follow-up), using a PA monitor and a PA diary. Participants were categorized as either maintainers (change in minutes/week of aerobic PA ≥ 0 and/or change in number of sessions/week of resistance training ≥0) or non-maintainers. Data on potential predictors were collected at baseline and at the end of the exercise intervention. Multiple logistic regression analyses were performed to answer both research questions. Results A total of 301 participants (52%) completed the data assessments. A main effect of BCTs on PA maintenance was found (OR = 1.80, 95%CI [1.05–3.08]) at 12-month follow-up. Participants reporting higher health-related quality-of-life (HRQoL) (OR = 1.03, 95%CI [1.00–1.06] and higher exercise motivation (OR = 1.02, 95%CI [1.00–1.04]) at baseline were more likely to maintain PA levels at 12-month follow-up. Participants with higher exercise expectations (OR = 0.88, 95%CI [0.78–0.99]) and a history of tobacco use at baseline (OR = 0.43, 95%CI [0.21–0.86]) were less likely to maintain PA levels at 12-month follow-up. Finally, participants with greater BMI increases over the course of the exercise intervention (OR = 0.63, 95%CI [0.44–0.90]) were less likely to maintain their PA levels at 12-month follow-up. Conclusions Self-regulatory BCTs improved PA maintenance at 12-month follow-up and can be recommended to cancer survivors for long-term PA maintenance. Such support should be considered especially for patients with low HRQoL, low exercise motivation, high exercise expectations or with a history of tobacco use at the start of their cancer treatment, as well as for those gaining weight during their treatment. However, more experimental studies are needed to investigate the efficacy of individual or combinations of BCTs in broader clinical populations. Trial registration NCT02473003 (10/10/2014).

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Evaluation of the Value of Attribution in the Interpretation of Adverse Event Data: A North Central Cancer Treatment Group and American College of Surgeons Oncology Group Investigation

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.4282 ◽

2010 ◽

Vol 28 (18) ◽

pp. 3002-3007 ◽

Cited By ~ 34

Author(s):

Shauna L. Hillman ◽

Sumithra J. Mandrekar ◽

Brian Bot ◽

Ronald P. DeMatteo ◽

Edith A. Perez ◽

...

Keyword(s):

Clinical Trials ◽

Treatment Group ◽

Cancer Treatment ◽

Randomized Clinical Trials ◽

Study Drug ◽

Phase Iii ◽

Oncology Group ◽

North Central ◽

American College Of Surgeons ◽

Group Trial

Purpose In March 1998, Common Toxicity Criteria (CTC) version 2.0 introduced the collection of attribution of adverse events (AEs) to study drug. We investigate whether attribution adds value to the interpretation of AE data. Patients and Methods Patients in the placebo arm of two phase III trials—North Central Cancer Treatment Group Trial 97-24-51 (carboxyamino-triazole v placebo in advanced non–small-cell lung cancer) and American College of Surgeons Oncology Group Trial Z9001 (imatinib mesylate v placebo after resection of primary gastrointestinal stromal tumors)—were studied. Attribution was categorized as unrelated (not related or unlikely) and related (possible, probable, or definite). Results In total, 398 patients (84 from Trial 97-24-51 and 314 from Trial Z9001) and 7,736 AEs were included; 47% and 50% of the placebo-arm AEs, respectively, were reported as related. When the same AE was reported in the same patient on multiple visits, the attribution category changed at least once 36% and 31% of the time. AE type and sex (Trial Z9001) and AE type and performance status (Trial 97-24-51) were associated with a higher likelihood of AEs being deemed related. Conclusion Nearly 50% of AEs were reported as attributed to study drug on the placebo arm of two randomized clinical trials. These data provide strong evidence that AE attribution is difficult to determine, unreliable, and of questionable value in interpreting AE data in randomized clinical trials.

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Measuring the Incremental Cost of Clinical Cancer Research

Journal of Clinical Oncology ◽

10.1200/jco.2001.19.1.105 ◽

2001 ◽

Vol 19 (1) ◽

pp. 105-110 ◽

Cited By ~ 20

Author(s):

Dana P. Goldman ◽

Michael L. Schoenbaum ◽

Arnold L. Potosky ◽

Jane C. Weeks ◽

Sandra H. Berry ◽

...

Keyword(s):

Clinical Trials ◽

Cancer Treatment ◽

Incremental Cost ◽

Cancer Patients ◽

Phase Ii ◽

The United States ◽

Phase Iii ◽

Ongoing Effort ◽

Cancer Trials ◽

The Cost

PURPOSE: To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials. METHODS: A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute–sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost. RESULTS: Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs. CONCLUSION: Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.

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Dealing With a Deluge of Data: An Assessment of Adverse Event Data on North Central Cancer Treatment Group Trials

Journal of Clinical Oncology ◽

10.1200/jco.2004.00.0588 ◽

2005 ◽

Vol 23 (36) ◽

pp. 9275-9281 ◽

Cited By ~ 23

Author(s):

Michelle R. Mahoney ◽

Daniel J. Sargent ◽

Michael J. O'Connell ◽

Richard M. Goldberg ◽

Paul Schaefer ◽

...

Keyword(s):

Clinical Trials ◽

Adverse Event ◽

Patient Safety ◽

Treatment Group ◽

Cancer Treatment ◽

Phase Iii ◽

Small Subset ◽

North Central ◽

Normal Limits ◽

Life Threatening

Purpose Adverse events (AEs) are monitored in clinical trials for patient safety, to satisfy reporting requirements, and develop safety profiles. Recently, much attention has been placed on the reporting of serious AEs (SAEs) that are either life threatening or lethal in clinical trials. However, SAEs comprise a small subset of all AE data collected for trials; the majority of AE data collected are routine AEs (RAEs) regarding non–life-threatening events. We assessed the utility of the RAE data collected, relative to the volume. Patients and Methods We surveyed the RAE data from 26 North Central Cancer Treatment Group coordinated trials. Results A total of 8,318 (11%) of 75,598 of RAEs required queries. Of these, 86% were protocol-required RAEs, 83% of RAEs required per protocol were within normal limits (eg, platelets) or not present, and 61% of extra AEs were mild. One fifth of RAEs were considered unlikely to be related or unrelated to treatment. Overall, 3% of events were severe, life threatening, or caused death. Only 1% of RAE data reported required expedited reporting (eg, via Adverse Event Expedited Reporting System). Results indicate that 72% of RAEs would be eliminated if only the maximum severity per patient and type were required. These results were validated in a large phase III trial. Conclusion The majority of RAEs identified, transcribed, and entered are not clinically important. Our data suggest that reducing the number of AEs monitored will affect substantially neither overall patient safety nor compromise evaluation of regimens undergoing testing. We present several considerations for such a reduction in data collection, as well as a policy that we have used to address the deluge of RAE data.

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Efficacy of Chemotherapeutic Regimens for Mantle Cell Lymphoma: A Systematic Review of Phase III Trials

Blood ◽

10.1182/blood-2020-141181 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 6-7

Author(s):

Ali Jaan ◽

Muhammad Tayyeb ◽

Farhan Khalid ◽

Muhammad Khawar Sana ◽

Zahoor Ahmed ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Mantle Cell Lymphoma ◽

Cell Lymphoma ◽

Interferon Alfa ◽

Phase Iii ◽

Cell Transplant ◽

Mantle Cell ◽

Combination Regimens

Background: The mainstay treatment for mantle cell lymphoma (MCL) is chemotherapy ± immunotherapy. The standard chemotherapeutic regimens have limited efficacy in MCL when used alone. In this systematic review, we have assessed the efficacy and safety of various combination regimens for the treatment of MCL evaluated in phase III clinical trials. Methods: We performed a comprehensive systematic literature search on PubMed, Embase, clinicaltrials.gov, and Web of Science databases with the date of inception to May 2020. We used MeSH (Medical Subject Headings) terms for "mantle cell lymphoma", "treatment outcome" along with their keywords, and combined their results. Our search generated a total of 3572 articles. After excluding case reports, case series, observational studies, review articles, meta-analysis, phase I/II clinical trials, and pre-clinical studies, we included five phase III randomized clinical trials (RCTs) reporting the efficacy of combination regimens for MCL treatment. Results Data from five phase III RCTs was pooled with total N=1683 (newly diagnosed (ND), n=1242, relapsed/refractory (RR), n=441). 1610 patients were evaluable. Kluin-Nelemans et al. 2020 (n=560) studied induction with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) vs R-FC (rituximab, fludarabine, and cyclophosphamide) for ND-MCL with follow-up on maintenance with rituximab (R) -vs interferon alfa. At a median follow up of 7.6 years (y), median overall survival (mOS) was 6.4 vs 3.9 y (p=0.0054) in R-CHOP vs R-FC group, respectively. The median progression-free survival (mPFS) and mOS in the R-CHOP cohort on R maintenance were significantly better when compared to those on interferon alfa maintenance (mPFS, 5.4 y vs 1.9 y, p<0.001) (mOS, 9.8 y vs 7.1 y, p=0.0026). Robak et al. (2015) (n=487) assessed bortezomib in ND-MCL by substituting it for vincristine in the standard R-CHOP therapy. A cohort of MCL ineligible for stem cell transplant (SCT) was randomly assigned to either R-CHOP or VR-CAP (bortezomib replacing vincristine). At a median follow-up of 40 months (mo), mPFS was 24.7 mo vs 14.4 mo in VR-CAP vs R-CHOP (HR 0.63, p<0.001), respectively. Similar, relative improvements were reported in complete response (CR) (53% vs 42%, p=0.007) and 4-year OS was (64% [95% CI 56-71] vs 54% [95% CI 45-62]). Jin et al. (2018) (n=121) assessed R-CHOP vs VR-CAP in ND-MCL patients ineligible for SCT. After a median follow-up of 42.4 mo, mPFS for VR-CAP was better than R-CHOP (28.6 mo vs 13.9 mo, HR=0.7, p=0.157). The overall response rate (ORR) was almost similar in VR-CAP (97%) and R-CHOP (98%). The 4-year OS was 62% vs 61% in VR-CAP vs R-CHOP, respectively. Flinn et al. (2014) (n=74) studied the efficacy of bendamustine in combination with rituximab (BR) vs R-CHOP or R-CVP (R-CHOP minus doxorubicin) as induction regimens in ND-MCL. 36 patients received BR and 38 patients received R-CHOP/R-CVP. ORR was 94% vs 85% with BR vs R-CHOP/R-CVP, respectively. Hess et al. (2009) (n=162) evaluated temsirolimus in RR-MCL. The study population was randomized to either 175/75mg temsirolimus (arm A), 175/25mg temsirolimus (arm B), and the investigator's choice of chemotherapy (arm C). The mPFS was significantly better in arm A compared to arm C (4.8 mo vs 1.9 mo, HR 0.44 [97.5% CI 0.25-0.7], p=0.0009). Arm B had slight improvement but insignificant. Similarly, mOS was 12.8 mo in arm A (HR 0.8 [95% CI 0.5-1.28], p=0.35), and 8.8 in arm B (HR 0.96 [95% CI 0.60-1.54], p=0.87), when compared to 9.5 mo in arm C. Drelying et al. (2016) (n=280), studied temsirolimus in comparison with ibrutinib, RR-MCL with mPFS of 14.6 mo (95% CI 10.4-not estimable) vs 6.2 mo (95% CI 4.2-7.9), respectively. Toxicities were typically manageable. VR-CAP was associated with a higher incidence of toxicity (100%) vs R-CHOP (94%) majority of which was hematological. Thrombocytopenia was particularly more prominent with temsirolimus. Granulocytopenia was persistent in 30-40% in the R-FC cohort after 5 y. Conclusion: The chemo-immunotherapy combination is favorable compared to chemotherapy alone for the treatment of MCL. R-CHOP induction followed by rituximab maintenance in MCL shows favorable long-term safety and efficacy profile. Bortezomib substituting for vincristine in R-CHOP improves the efficacy outcomes. Ibrutinib-based regimens are superior to temsirolimus-based regimens. Disclosures Anwer: Incyte, Seattle Genetics, Acetylon Pharmaceuticals, AbbVie Pharma, Astellas Pharma, Celegene, Millennium Pharmaceuticals.:Honoraria, Research Funding, Speakers Bureau.

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Use of routinely collected health data in randomised clinical trials: comparison of trial-specific death data in the BOSS trial with NHS Digital data

Trials ◽

10.1186/s13063-021-05613-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Sharon B. Love ◽

Anna Kilanowski ◽

Victoria Yorke-Edwards ◽

Oliver Old ◽

Hugh Barr ◽

...

Keyword(s):

Overall Survival ◽

Clinical Trials ◽

Oesophageal Cancer ◽

Health Data ◽

Digital Data ◽

Phase Iii ◽

Specific Data ◽

Routinely Collected Health Data ◽

Death Data

Abstract Background A promising approach to reduce the increasing costs of clinical trials is the use of routinely collected health data as participant data. However, the quality of this data could limit its usability as trial participant data. Methods The BOSS trial is a randomised controlled trial comparing regular endoscopies versus endoscopies at need in patients with Barrett’s oesophagus with primary endpoint death. Data on death and cancer collected every 2 years after randomisation (trial-specific data) were compared to data received annually (all patients on one date) from the routinely collected health data source National Health Service (NHS) Digital. We investigated completeness, agreement and timeliness and looked at the implications for the primary trial outcome. Completeness and agreement were assessed by evaluating the number of reported and missing cases and any disparities between reported dates. Timeliness was considered by graphing the year a death was first reported in the trial-specific data against that for NHS Digital data. Implications on the primary trial outcome, overall survival, of using one of the data sources alone were investigated using Kaplan-Meier graphs. To assess the utility of cause of death and cancer diagnoses, oesophageal cancer cases were compared. Results NHS Digital datasets included more deaths and often reported them sooner than the trial-specific data. The number reported as being from oesophageal cancer was similar in both datasets. Due to time lag in reporting and missing cases, the event rate appeared higher using the NHS Digital data. Conclusion NHS Digital death data is useful for calculating overall survival where trial-specific follow-up is only every 2 years from randomisation and the follow-up requires patient response. The cancer data was not a large enough sample to assess usability. We suggest that this assessment of registry data is done for more phase III RCTs and for more registry data to get a more complete picture of when RCHD would be useful in phase III RCT. Trial registration ISRCTN54190466 (BOSS) 1 Oct 2009.

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Mobile health tool for monitoring cancer treatment complications.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.29_suppl.297 ◽

2020 ◽

Vol 38 (29_suppl) ◽

pp. 297-297

Author(s):

Amit Sanyal ◽

James M. Heun ◽

Clemens walter Janssen ◽

Jessica Sweeney

Keyword(s):

Cancer Treatment ◽

Cancer Patients ◽

Mobile Health ◽

Care Delivery ◽

Symptom Burden ◽

Cost Of Care ◽

Phase Iii ◽

Screening Methods ◽

Distress Screening

297 Background: Side effects after cancer treatment are ubiquitous, seen in up to 98.3% of patients in one Phase III lymphoma trial. Additionally, cancer patients are at a greater risk of mortality from infections such as coronavirus disease 2019 (COVID-19), prompting recommendations for routine screening. Current care delivery model, reliant on self- triaging of symptoms by patients results in delayed management and avoidable emergency room visits and hospitalizations. Technology based symptom monitoring allows early identification of complications, reduces symptom burden, cost of care and enables early detection of relapse. We studied utility of a mobile-health tool for toxicity monitoring and COVID-19 screening. Methods: We developed an application that periodically delivers disease specific toxicity questionnaires to patients following cancer treatment. Based on NCI- PRO-CTCAE form builder, the questions are delivered through SMS or e-mail. Responses crossing pre-specified thresholds are flagged for manual care team follow-up. Patient and staff experience as well as medical interventions are captured. Results: Currently, 68 patients with different malignancies are enrolled. Median age 60 years (range 24-85), 35 males, 31 females. 72.35% patients rated user experience at 4 or higher (1-5 scale, 5 highest). Aggregate provider rating was 3.25 (1-5 scale, 5 highest). Of 639 captured responses, 157 reported fatigue, 145 no symptoms, 57 nausea/vomiting or diarrhea, 52 numbness/tingling and 48 shortness of breath. 76 responses were flagged for nurse follow-up calls. These resulted in 72 successful outpatient symptom management, 2 hospitalizations for neutropenic fever, 1 MRI diagnosis of radiation necrosis and 1 diagnosis of lymphoma progression. 92% of patients received a follow up within one business day. Median time between response recorded and follow up completed was 55 minutes. Of 1299 responses recorded by COVID-19 screening, 1175 reported no symptoms. All positive responses (47 cough, 52 diarrhea, 5 fever and 20 dyspnea) were false positives. Study is ongoing with recent implementation of a distress screening and survivorship modules. Conclusions: Electronic capture of symptoms using connected technology is feasible and can be used to screen cancer patients for treatment related complications as well as pandemic related illnesses.

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Mobile-health tool for timely management of cancer treatment toxicity.

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.321 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 321-321

Author(s):

Amit Sanyal ◽

Sara Mistretta ◽

Morgan Fulton ◽

Clemens walter Janssen

Keyword(s):

Cancer Treatment ◽

Patient Experience ◽

Mobile Health ◽

B Cell Lymphoma ◽

Cost Of Care ◽

Phase Iii ◽

Free Text ◽

Common Symptom ◽

Patient Reported

321 Background: Treatment related side effects after chemotherapy are common, with significant toxicities seen in 78.2% to 98.3% of patients allocated to two study arms of a lymphoma trial [1]. While most oncology clinics provide patient education before treatment, onetime delivery of large amounts of information without reiteration of crucial facts results in information gaps, delay in seeking care, culminating in potentially avoidable ED visits and hospitalizations. Technology based symptom monitoring can facilitate early detection of complications, reduce symptom burden and cost of care. Here we update our study [2] of utility of a mobile-health tool for timely management of cancer treatment related toxicities in a community-based oncology practice. Methods: A web-based mobile application consisting of a patient interface, a provider interface and an embedded analytic platform was developed. Patient ‘check-ins’ incorporating a brief introduction and chemotherapy toxicity questionnaires are delivered through automated text or email. Toxicity questionnaires are based on the NCI-PRO-CTCAE ITEMS-ENGLISH form builder. The provider interface incorporates a ‘patient records summary’ page and a ‘tracker’ page, allowing the oncology care team to monitor responses in real-time. Responses exceeding pre-specified thresholds generate a color-coded ‘flag’ and are marked for follow up. Flags result in a phone call followed by in-person evaluation if necessary. All interventions are time stamped. Patient experience is measured concurrently using a Likert-scale as well as free-text response box. Results: 310 patients were enrolled as of January 21, 2021. Median age was 64 years. There were 49% females.8916 check-ins were sent out and 2963 responses recorded for an overall response rate of 33.23%. 531 responses provided by 109 unique patients were flagged for follow up, amounting to 6% of all responses. Fatigue was the most common symptom flagged for follow-up (454), followed by nausea/vomiting or diarrhea (167), abdominal pain (140), cough/dyspnea (140) and numbness/tingling (138). Follow up was prompt, with 60% of patient symptoms followed up on the same day and of these, 84% followed-up within 4 hours of patient reported symptom. Patient experience was consistently favorable. 72% of patients reported an experience score of ≥ 4 (1-5 scale, 5 being the most favorable). Conclusions: Electronic capture of symptoms using connected technology is feasible and can be used for timely management of treatment related complications. References: Bartlett, N.L., et al., Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303. J Clin Oncol, 2019. 37(21): p. 1790-1799. Sanyal, A. Mobile health tool for monitoring cancer treatment complications. 2020. ASCO Quality Care Symposium: American Society of Clinical Oncology.

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