Mobile health tool for monitoring cancer treatment complications.

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.

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

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.

Measuring the Incremental Cost of Clinical Cancer Research

2001 ◽  
Vol 19 (1) ◽  
pp. 105-110 ◽  
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.

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

2002 ◽  
Vol 20 (2) ◽  
pp. 545-556 ◽  
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.

Overall survival in patients with lung cancer using a web-application-guided follow-up compared to standard modalities: Results of phase III randomized trial.

2016 ◽  
Vol 34 (18_suppl) ◽  
pp. LBA9006-LBA9006 ◽  
Author(s):  
Fabrice Denis ◽  
Claire Lethrosne ◽  
Nicolas Pourel ◽  
Olivier Molinier ◽  
Yoann Pointreau ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
High Risk ◽  
Supportive Care ◽  
Cancer Patients ◽  
Web Application ◽  
Phase Iii ◽  
P Value ◽  
Lung Cancer Patients

LBA9006 Background: We developed a web-application for an early detection of symptomatic relapse, complications and early supportive care in high-risk lung cancer patients between visits. A dynamical analysis of the weekly self-reported symptoms automatically triggered physician visit. Methods: We performed a national multi-institutional phase 3 prospective randomized study to compare web-application follow-up (experimental arm) for which patient’s self-scored symptoms that were weekly sent (between planned visits) to the oncologist and a clinical routine assessment with a CT-scan (every 3-6 months or at investigator’s discretion - standard arm). High risk lung cancer patients without progression and with a 0-2 performance status (PS) after an initial treatment were included. Maintenance chemotherapy or TKI therapy were allowed. In the experimental arm, an email alert was sent to the oncologist when some predefined clinical criteria were fulfilled: an imaging was then quickly prescribed. Early supportive cares were provided if adequate. The primary endpoint was to detect an improvement of 12% in 9 months survival in favor of the experimental arm (α = 5%, β = 20%, unilateral test). The boundary for declaring superiority with respect to overall survival at the pre-planned interim analysis was a p-value of less than 0.006. The PS at relapse, the quality of life (QOL) and cost-effectiveness were also investigated. Results: 121 patients were included in the intent-to-test survival analysis (90% were stage III/IV, median age: 65 y): 60 (61) in the experimental (standard) arms with equivalent baseline characteristics. Median follow-up was 9 months. Median overall survival in months was 19 (11.8), p=0.0014 (n  =  121; HR  =  0.33; 95 % CI, 0.16-0.67) and the PS at the first relapse was 0-1 for 81.5% (35.3%) of the patients (p<0.001) in the experimental (standard) arm. Conclusions: This trial shows a significant survival improvement using Web-application-guided follow-up that allowed better PS at relapse, earlier supportive care and reduction of routine imaging. QOL and cost analysis results will be presented during the meeting. Clinical trial information: NCT02361099.

Comprehensive distress screening and referral at a tertiary cancer center.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 134-134
Author(s):  
Elizabeth Trice Loggers ◽  
Stephen Duane Watkins King ◽  
Jesse R Fann ◽  
Kerry K McMillin ◽  
Jodie HN David ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Well Being ◽  
Cancer Center ◽  
Screening Methods ◽  
Distress Screening ◽  
Web Based ◽  
Care Services ◽  
Existential Crisis ◽  
Patient Health ◽  
English Speaking

134 Background: Addressing distress in cancer patients is now broadly recognized as critical to well-being and associated with increased survival. Cancer centers are developing innovative distress screening methods; we describe our novel process and results. Methods: New patients from 9/2015 to 3/2017 received an email requesting completion of a 44-item web-based survey assessing depression (2-item Patient Health Questionnaire), anxiety (2-item Generalized Anxiety Disorder), quality of life (QOL, 28-item Functional Assessment of Cancer Treatment-General), malnutrition (3-item Malnutrition Screening Tool), and 9 items addressing existential crisis, physical function, symptoms, tangible needs and concerns for dependent children. Results were computer scored, with positive screens resulting in direct, automated referrals to supportive care services (SCR). Analysis includes descriptive statistics and logistic regression using SAS 9.4. Results: 71% (n = 2629 of 3724) of those approached provided an email and completed the survey; 73% reporting no survey burden. Non-responders were more likely to be minority, non-English speaking, with non-commercial insurance (all p < 0.001). 59% (n = 1543) of responders screened positive for one or more SCR, including 6% to palliative care for poor QOL or symptoms. Receipt of SCR was more likely with Medicaid insurance (1.36 odds ratio [OR], 95% confidence interval [CI] 1.06-1.76, p = .0061); plan to receive care (1.27 OR, CI 1.07-1.50, p = .0061); and any report of survey burden (2.26 OR, CI 1.83-2.80, p < .0001). Conclusions: Web-based distress screening is feasible, efficient and not burdensome for the majority of cancer patients. Those who find this screening burdensome are two-fold more likely to have distress. Future efforts should address screening of vulnerable populations.

Anxiety among immunotherapy patients: Preliminary findings from Immunotherapy & Me.

2020 ◽  
Vol 38 (5_suppl) ◽  
pp. 104-104
Author(s):  
Alyssa Marie Jaisle ◽  
Nicholas James Power ◽  
Linda S. House ◽  
Tameka N. Jones ◽  
Lee S. Schwartzberg
Keyword(s):  
Cancer Treatment ◽  
Cancer Patients ◽  
Age Groups ◽  
Diagnosis And Treatment ◽  
Distress Screening ◽  
Physically Active ◽  
Cancer Support ◽  
Support Resources ◽  
World Class ◽  
And Gender

104 Background: Immunotherapy is a relatively new method of cancer treatment which has seen little research into its psychosocial side effects. A clearer understanding of the source of anxiety for those undergoing immunotherapy is crucial as anxiety during cancer treatment can result in decreased treatment adherence, increased mortality rates, and other negative outcomes. This study surveyed 112 cancer patients undergoing immunotherapy to understand their top treatment-related concerns. Methods: RNs in twelve clinics across the U.S. recruited participants into Immunotherapy & Me, a study run by the Cancer Support Community (CSC). Participants were given access to a selection of CSC’s world-class support resources designed to help them and their loved ones manage their treatment. While accessing these resources, participants were encouraged to complete a monthly survey online either at their clinic or at home for seven months. This survey included CancerSupportSource – CSC’s scientifically-validated distress screening tool – as well as some additional questions specifically tailored to immunotherapy patients. Results: The most frequent source of concern related to diagnosis and treatment was “feeling too tired to do things you want to need or do” ( M = 1.21, SD = 1.01), closely followed by “exercising and being physically active” ( M = 1.05, SD = .93). Other concerns included the future ( M = 1.03, SD = .99) and financial ( M = 1.02, SD = 1.16). There were significant differences between age groups in concerns about disruption to life F(4, 97) = 3.52, p < .01; pain F(4,97) = p < .05; finances F(4,97) = 2.86, p < .05; and fatigue F(4, 96) = 2.47, p< .05. Older participants were significantly less concerned about disruption to life as compared to younger participants while younger participants were more concerned about pain than older participants. Conclusions: Cancer patients undergoing immunotherapy do not have a single, outstanding concern. Instead, these patients have several concerns, the level of which varies significantly between age groups and gender. This suggests the need for a subsequent study that explores a more refined list of categories and probes which specific aspects of diagnosis and treatment generate these concerns. Clinical trial information: NCT03347058.

Distress screening remains important during follow-up after primary breast cancer treatment

2013 ◽  
Vol 21 (8) ◽  
pp. 2107-2115 ◽  
Author(s):  
Floortje K. Ploos van Amstel ◽  
Sanne W. van den Berg ◽  
Hanneke W. M. van Laarhoven ◽  
Marieke F. M. Gielissen ◽  
Judith B. Prins ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Treatment ◽  
Primary Breast Cancer ◽  
Breast Cancer Treatment ◽  
Distress Screening

Up to 15-year clinical follow-up of a pilot Phase III immunotherapy study in stage II breast cancer patients using oxidized mannan–MUC1

Immunotherapy ◽  
2013 ◽  
Vol 5 (11) ◽  
pp. 1177-1182 ◽  
Author(s):  
Stamatis Vassilaros ◽  
Anastasios Tsibanis ◽  
Annivas Tsikkinis ◽  
Geoffrey A Pietersz ◽  
Ian FC McKenzie ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Stage Ii ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Pilot Phase ◽  
Immunotherapy Study

scholarly journals “I’m Dealing With That”: Illness Concerns of African American and White Cancer Patients While Undergoing Active Cancer Treatments

2020 ◽  
pp. 104990912096912
Author(s):  
Salimah H. Meghani ◽  
Kristin Levoy ◽  
Kristin Corey Magan ◽  
Lauren T. Starr ◽  
Liana Yocavitch ◽  
...  
Keyword(s):  
Palliative Care ◽  
African American ◽  
Cancer Treatment ◽  
Cancer Patients ◽  
Risk Mitigation ◽  
Care Delivery ◽  
Care Transitions ◽  
Financial Toxicity ◽  
Cancer Treatments ◽  
Illness Trajectory

Background: National oncology guidelines recommend early integration of palliative care for patients with cancer. However, drivers for this integration remain understudied. Understanding illness concerns at the time of cancer treatment may help facilitate integration earlier in the cancer illness trajectory. Objective: To describe cancer patients’ concerns while undergoing cancer treatment, and determine if concerns differ among African Americans and Whites. Methods: A 1-time, semi-structured qualitative interview was conducted with a purposive subsample of cancer patients participating in a larger study of illness concerns. Eligible patients were undergoing cancer treatments and had self-reported moderate-to-severe pain in the last week. Analysis encompassed a qualitative descriptive approach with inductive thematic analysis. Results: Participants (16 African American, 16 White) had a median age of 53 and were predominantly females (72%) with stage III/IV cancer (53%). Illness concerns were largely consistent across participants and converged on 3 themes: symptom experience (pain, options to manage pain), cancer care delivery (communication, care coordination and care transitions), and practical concerns (access to community and health system resources, financial toxicity). Conclusions: The findings extend the scope of factors that could be utilized to integrate palliative care earlier in the cancer illness trajectory, moving beyond the symptoms- and prognosis-based triggers that typify current referrals to also consider diverse logistical concerns. Using this larger set of concerns aids anticipatory risk mitigation and planning (e.g. care transitions, financial toxicity), helps patients receive a larger complement of support services, and builds cancer patients’ capacity toward a more patient-centered treatment and care experience.

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