Feasibility of integrating the Outcomes4Me smartphone navigation application into the care of breast cancer patients (FIONA).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1570-1570
Author(s):  
Steven J. Isakoff ◽  
Maya Said ◽  
Agnes H. Kwak ◽  
Eva Glieberman ◽  
Amanda Stroiney ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Pilot Study ◽  
Patient Engagement ◽  
Medical Center ◽  
Treatment Options ◽  
Academic Medical Center ◽  
Patient Reported ◽  
Clinical Trial Information

1570 Background: Patients diagnosed with breast cancer (BC) face complex decisions about their care and many studies have shown that improved patient engagement results in increased satisfaction and better outcomes. Patient engagement includes education, treatment option selection, symptom tracking and reporting, and clinical trial opportunities. We conducted a pilot study to determine the feasibility of introducing the Outcomes4Me patient engagement app into the standard of care experience of BC patients. Methods: This was a pilot study (NCT04262518) conducted at an academic medical center. Eligible patients had any subtype of stage 1-4 BC and were on any type of chemo-, hormonal-, targeted-, or radiation-therapy for BC during the study period. Participants downloaded the app on their smartphone and their app usage was evaluated. Surveys were administered at baseline and end of study. Clinicians caring for patients using the app were surveyed at the end of the study. The primary endpoint was feasibility, defined as at least 40% of patients engaging with the app at least 3 times over the 12-week study period. Additional endpoints included usability, satisfaction, correlation of patient reported data with the EHR, clinical trial matching, and patient experience. Results: Between June 2020 and December 2020, 107 patients enrolled; results are reported for 90 patients with complete data as of 1/24/21. Baseline demographics: median age 53 (range: 27-77); 90% White, 4% Black, 3% Asian; 66% had hormone positive/HER2-, 20% HER2+, and 13% triple negative BC; 31% had stage 4 disease. At study entry, 93% had never used an app to help with their disease or treatment options. Over the 12 week study period, 58% of patients engaged with the app at least 3 times, meeting the primary feasibility endpoint. Patients engaged with the app on average 5.5 days (range: 0-40) with 20% engaging on more than 10 days during the study. The mean System Usability Score was 71 (median = 76) and was similar across age groups. The 5 app features deemed most (‘somewhat’ or ‘very’) helpful were: background about their BC (76%), information about treatment options (74%), newsfeed about their BC (70%), symptom tracking (65%), and clinical trial information (65%). 53% said that the app helped them keep track of symptoms and 33% said they are more likely to explore or enroll in a clinical trial after using the app. Conclusions: Integration of the Outcomes4Me app into the care management of BC patients is feasible with acceptable usability. Our results suggest that use of a patient smartphone app may be helpful for many aspects of patient education and engagement for patients with BC. The results also suggest that this type of intervention can help patients better track their symptoms and make them aware of clinical trials, potentially facilitating the management of side effects and accelerating clinical trials recruitment. Clinical trial information: NCT04262518.

scholarly journals Integrating Oncology Massage Into Chemoinfusion Suites: A Program Evaluation

2017 ◽  
Vol 13 (3) ◽  
pp. e207-e216 ◽  
Author(s):  
Jun J. Mao ◽  
Karen E. Wagner ◽  
Christina M. Seluzicki ◽  
Audra Hugo ◽  
Laura K. Galindez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Program Evaluation ◽  
Clinical Oncology ◽  
Medical Center ◽  
Symptom Control ◽  
Academic Medical Center ◽  
Distress Thermometer ◽  
Integrative Approach ◽  
Patient Reported ◽  
Oncology Massage

Objective: This article reports on the development, implementation, and evaluation of an integrative clinical oncology massage program for patients undergoing chemotherapy for breast cancer in a large academic medical center. Materials and Methods: We describe the development and implementation of an oncology massage program embedded into chemoinfusion suites. We used deidentified program evaluation data to identify specific reasons individuals refuse massage and to evaluate the immediate impact of massage treatments on patient-reported outcomes using a modified version of the Distress Thermometer delivered via iPad. We analyzed premassage and postmassage data from the Distress Thermometer using paired t test and derived qualitative data from participants who provided written feedback on their massage experiences. Results: Of the 1,090 massages offered, 692 (63%) were accepted. We observed a significant decrease in self-reported anxiety (from 3.9 to 1.7), nausea (from 2.5 to 1.2), pain (from 3.3 to 1.9), and fatigue (from 4.8 to 3.0) premassage and postmassage, respectively (all P < .001). We found that 642 survey participants (93%) were satisfied with their massage, and 649 (94%) would recommend it to another patient undergoing treatment. Spontaneous patient responses overwhelmingly endorsed the massage as relaxing. No adverse events were reported. Among the 398 patients (36%) who declined a massage, top reasons were time concerns and lack of interest. Conclusion: A clinical oncology massage program can be safely and effectively integrated into chemoinfusion units to provide symptom control for patients with breast cancer. This integrative approach overcomes patient-level barriers of cost, time, and travel, and addresses the institutional-level barrier of space.

Accelerating the clinical trial start-up process for early-phase cancer studies: A test of process change to support rapid activation in an academic medical center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17507-e17507 ◽  
Author(s):  
Sheilah K Hurley ◽  
Therica M Miller ◽  
Rebecca Flores Stella ◽  
Keren Dunn ◽  
Ryan Schroeder ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Center ◽  
Academic Medical Center ◽  
Cancer Center ◽  
Small Series ◽  
Academic Medical ◽  
One Year ◽  
Activation Times ◽  
High Level

e17507 Background: Clinical trial sponsors have strong scientific, financial, and regulatory interests in rapidly activating studies at participating sites. Academic medical centers have difficulty activating trials within a few weeks of sponsor agreement because, among other inefficiencies, they engage the necessary committee reviews, regulatory approvals, contracting, and budgeting in serial fashion. Incremental revisions in such workflows do not result in strong improvements. Methods: We redesigned our institutional workflow to complete clinical trial activation tasks within six weeks. Historical procedures were replaced rather than scrutinized. A high level leadership committee was required to change and integrate procedures across the medical center, and engage sponsors to improve their turnaround times. A web-based collaborative workflow tracking tool was created to help coordinate the necessary tasks and measure performance. Six clinical trials from the Cancer Center portfolio were used to test and improve the new workflow. Results: Clinical trial activation redesign took one year. For the six studies used as tests of change, the activation times were 49, 54, 78, 58, 62, and 32 days. Times in excess of 6 weeks were largely due to sponsor delays. Conclusions: Considerable effort is required to significantly alter a complex workflow like clinical trial activation. Appropriate priorities, leadership, staffing, and tools are required. Markedly shortened study activation for a small series of cancer trials taught our academic medical center lessons that will be useful for improving the process for all clinical trials, and will make us a better partner for pharmaceutical and academic sponsors as well as for investigator initiated research. [Table: see text]

scholarly journals Clinical Trial Information As a Measure of Quality Cancer Care

2010 ◽  
Vol 6 (3) ◽  
pp. 170-171 ◽  
Author(s):  
Wei Chua ◽  
Stephen J. Clarke
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Treatment Options ◽  
Small Cell ◽  
Small Cell Lung ◽  
Quality Cancer Care ◽  
Improved Outcomes ◽  
New Treatment ◽  
Clinical Trial Information

Participation in clinical trials enables patients to access new treatment options. Evidence shows improved outcomes in participants compared with nonparticipants in non–small-cell, lung, breast, colorectal, and testicular cancers.

scholarly journals Cost-effectiveness of different surgical treatment approaches for early breast cancer: a retrospective matched cohort study from China

2020 ◽  
Author(s):  
Qing Yang ◽  
Xiaorong Zhong ◽  
Wei Zhang ◽  
Ting Luo ◽  
Ping He ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Surgical Treatment ◽  
Early Breast Cancer ◽  
Medical Center ◽  
Treatment Options ◽  
Academic Medical Center ◽  
Breast Conserving Surgery ◽  
Surgical Approaches ◽  
Treatment Approaches

Abstract Background Both breast-conserving surgery and breast reconstruction surgery are less popular in China, although they can improve patients' quality of life. The main reason comes from the economy. There is currently no economic evaluation of different surgical treatment options for early breast cancer. Our study aimed to evaluate the long-term cost-utilities of different surgical treatment approaches for early breast cancer. The surgical approaches are including mastectomy(MAST), breast-conserving therapy(BCT), and mastectomy with reconstruction (MAST+RECON). Methods We applied the propensity score matching method to perform a 1: 1 match on patients undergoing these three types of surgery in a tertiary academic medical center from 2011 to 2017 to obtain a balanced sample of covariates between groups. A Markov model was established. Clinical data and cost data were obtained from the medical records. Health utility values were derived from clinical investigations. Strategies were compared using an incremental cost-effectiveness ratio (ICER). Results The total cost of MAST, MAST+RECON and BCT was $35,282.24, $69,428.82 and $73,661.08, respectively. The discounted quality-adjusted life year(QALYs) were 17.94, 18.71 and 20.49, respectively. Compared with MAST, MAST+RECON and BCT have an ICER of $106708.06/QALY and $15050.53/QALY, respectively. The ICER of BCT vs. MAST was less than the threshold of $27,931.04. The reliability and stability of the results were confirmed by Monte Carlo simulation and sensitivity analysis. Conclusions We believe that in the context of the limited resources in China, after comparing the three surgical approaches, BCT is the more cost-effective and preferred solution.

A pilot study of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in a phase I clinical trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6587-6587 ◽  
Author(s):  
Rui Qin ◽  
Amylou C. Dueck ◽  
Daniel Satele ◽  
Julian R. Molina ◽  
Charles Erlichman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pilot Study ◽  
Adverse Events ◽  
Phase I ◽  
Patient Reported Outcomes ◽  
Point Of View ◽  
Phase I Clinical Trial ◽  
Phase I Clinical Trials ◽  
Patient Reported

6587 Background: Recently the Patient-Reported Outcomes version of the CTCAE was developed to augment clinically graded adverse events with information reported directly by patients on clinical trials (Basch, 2009). The validation and potential application of PRO-CTCAE in phase I clinical trials are of great interest as toxicity is the primary endpoint. Methods: Selected PRO-CTCAE items (21 items measuring 12 symptomatic adverse events) corresponding to the major adverse events required to be graded clinically were collected in an ongoing phase I clinical trial of weekly cilengitide and paclitaxel in patients with advanced solid malignancies (NCT01276496). PRO-CTCAE was administered in a paper booklet by a clinical research associate prior to treatment on days 1, 8 and 15 of their regular visits. These PRO-CTCAE items were summarized descriptively in comparison to clinician-assessed CTCAE ver 4.0 (NCI, 2009) during the first cycle. As a pilot study to assess feasibility of PRO-CTCAE in phase I trials, PRO-CTCAE was not intended for determination of dose-limiting toxicity. Results: Twelve patients were accrued to two separate doses of cilengitide and paclitaxel. The median age was 56 (range 36—67) and half of patients were female. All patients had an ECOG performance score <= 1. Over 90% of patients had received prior surgery and chemotherapy. All but one patient completed weekly PRO-CTCAE during the first cycle, the only patient refused to complete weeks 2 and 3 did not give a reason. PRO-CTCAE captured most of the symptomatic adverse events reflected in clinician-assessed CTCAE. Some symptomatic adverse events were not reported clinically by CTCAE but were reported by patients by PRO-CTCAE. Overall, PRO-CTCAE items indicated slightly more severe degree of symptoms experienced by patients than those reported in CTCAE. Conclusions: This is the first study that PRO-CTCAE items were integrated within regular study visits in a phase I trial. The administration of PRO-CTCAE has been proved feasible and fruitful, providing consistent and enhanced symptomatic toxicity from the patient point of view. The addition of PRO-CTCAE did not significantly increase patient burden. Clinical trial information: NCT01276496.

Factors Associated With Breast Cancer Clinical Trials Participation and Enrollment at a Large Academic Medical Center

2004 ◽  
Vol 22 (11) ◽  
pp. 2046-2052 ◽  
Author(s):  
Michael S. Simon ◽  
Wei Du ◽  
Lawrence Flaherty ◽  
Philip A. Philip ◽  
Patricia Lorusso ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Medical Center ◽  
Performance Status ◽  
Academic Medical Center ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Poor Performance Status ◽  
Cancer Clinical Trials ◽  
Factors Associated

Purpose The practice patterns of medical oncologists at a large National Cancer Institute Comprehensive Cancer Center in Detroit, MI were evaluated to better understand factors associated with accrual to breast cancer clinical trials. Patients and Methods From 1996 to 1997, physicians completed surveys on 319 of 344 newly evaluated female breast cancer patients. The 19-item survey included clinical data, whether patients were offered clinical trial (CT) participation and enrollment, and when applicable, reasons why they were not. Multivariate analyses using logistic regression were performed to evaluate predictors of an offer and enrollment. Results The patients were 57% white, 32% black, and 11% other/unknown race. One hundred six (33%) were offered participation and 36 (34%) were enrolled. In multivariate analysis, CTs were less likely offered to older women (mean age, 52 years for those offered v 57 years for those not offered; P = .0005) and black women (21% of blacks offered v 42% of whites; P = .0009). Women with stage 1 disease, poor performance status, and those who were previously diagnosed were also less likely to be offered trials. None of these factors were significant predictors of enrollment. Women were not offered trials because of ineligibility (57%), lack of available trials (41%), and noncompliance (2%). Reasons for failed enrollment included patient refusal (88%) and failed eligibility (12%). Conclusion It is important for cooperative groups to design studies that will accommodate a broader spectrum of patients. Further work is needed to assess ways to improve communication about breast cancer CT participation to all eligible women.

scholarly journals Cost-effectiveness of different surgical treatment approaches for early breast cancer: a retrospective matched cohort study from China

2020 ◽  
Author(s):  
Qing Yang ◽  
Xiaorong Zhong ◽  
Wei Zhang ◽  
Ting Luo ◽  
Ping He ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Surgical Treatment ◽  
Early Breast Cancer ◽  
Medical Center ◽  
Treatment Options ◽  
Academic Medical Center ◽  
Health Utility ◽  
Breast Conserving Surgery ◽  
Surgical Approaches

Abstract Background: Both breast-conserving surgery and breast reconstruction surgery are less popular in China, although they can improve patients' quality of life. The main reason comes from the economy. There is currently no economic evaluation of different surgical treatment options for early breast cancer. Our study aims to assess the economic impact and long-term cost-effectiveness of different surgical treatments for early breast cancer. The surgical approaches are including mastectomy (MAST), breast-conserving therapy (BCT), and mastectomy with reconstruction (MAST+RECON).Methods: We applied the propensity score matching method to perform a 1: 1 match on patients undergoing these three types of surgery in a tertiary academic medical center from 2011 to 2017 to obtain a balanced sample of covariates between groups. A Markov model was established. Clinical data and cost data were obtained from the medical records. Health utility values were derived from clinical investigations. Strategies were compared using an incremental cost-effectiveness ratio (ICER).Results: The total cost of MAST, MAST+RECON and BCT was $35,282.24, $69,428.82 and $73,661.08, respectively. The quality-adjusted life year (QALYs) were 17.94, 18.71 and 20.49, respectively. Compared with MAST, MAST+RECON and BCT have an ICER of $106708.06/QALY and $15050.53/QALY, respectively. The ICER of BCT vs. MAST was less than the threshold of $27,931.04. The reliability and stability of the results were confirmed by Monte Carlo simulation and sensitivity analysis.Conclusions: We believe that in the context of the limited resources in China, after comparing the three surgical approaches, BCT is the more cost-effective and preferred solution.

scholarly journals Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development (Preprint)

2017 ◽  
Author(s):  
Yu Rang Park ◽  
Young Jo Yoon ◽  
HaYeong Koo ◽  
Soyoung Yoo ◽  
Chang-Min Choi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Management System ◽  
Medical Center ◽  
Academic Medical Center ◽  
Trial Management ◽  
Privacy And Security ◽  
Academic Medical ◽  
Asan Medical ◽  
Clinical Trial Management

BACKGROUND Clinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations. OBJECTIVE The objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations. METHODS This study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations. RESULTS In this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects. CONCLUSIONS The CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws.

Concordance between patient-reported (PR) and physician-documented (PD) comorbidities and symptoms among Stage 4 breast cancer patients (pts).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24089-e24089
Author(s):  
Saumya Umashankar ◽  
Michelle E. Melisko ◽  
Halle Thannickal ◽  
Madeline B. Matthys ◽  
Laura van 't Veer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Proportional Hazards ◽  
Medical Center ◽  
Care Center ◽  
Academic Medical Center ◽  
Tumor Biology ◽  
Metastatic Breast ◽  
Cox Proportional Hazards ◽  
Breast Cancer Patients ◽  
Patient Reported

e24089 Background: Comorbidities (Co) and symptoms (Sx) in metastatic breast cancer (MBC) pts impact treatment decisions, eligibility for clinical trials, and influence prognosis and quality of life. The aim of this study was to evaluate the concordance between PR and PD Co and Sx in an electronic medical record to document pts’ health, identify Co or Sx that may be more comprehensively reported by pts vs physicians (phy), and understand if PR, PD, or concordant Co or Sx were more predictive of pt survival. Methods: New pts at UCSF’s Breast Care Center (BCC) are administered an electronic intake survey assessing PR health history, Co and Sx. Chart reviews of the initial clinic visit were conducted for PD Co and Sx. Pt and phy concordance was summarized for 54 Co and 42 Sx. Agreement was quantified using Cohen’s kappa (κ) (poor (κ < 0.2), fair (0.2≤κ < 0.4), moderate (0.4≤κ < 0.6), substantial to high (κ ≥0.6)). Cox-proportional hazards models were used to determine hazard ratios (HR) for survival with PR, PD, and concordant Co and Sx, controlling for factors including age, sites of metastatic disease, tumor biology, etc. Results: Between Nov 2016 and Feb 2020, 168 pts with confirmed MBC seen at the BCC who consented to use of their clinical data for research were included in the analysis (median age, 56 years; median time from MBC diagnosis, 0.46 years). Highest PD Co were obesity, hypertension (HTN) and thyroid disease, while highest PR Co were HTN, depression and arthritis. 23 of 54 Co had a moderate to high level of agreement between physician and pt reports (κ≥0.40). Agreement was high for diabetes, HTN, and low for obesity, anxiety, and gastroesophageal reflux disease (GERD). After controlling for clinical covariates, of these Co, only PR GERD was significantly associated with survival (HR = 1.87, p < 0.05). Only 2 of 42 Sx (shortness of breath and cough) had a moderate to high agreement between PD and PR. PR Sx were the primary drivers for predicting survival (HR > 1, p < 0.05 for PR Sx including vomiting, fatigue, weight loss and others). PD and PR agreement for these sx was poor (κ < 0.2). Conclusions: In this review of data collected as part of routine care at an academic medical center, there was substantial variance in the concordance of Co and Sx reported by pt vs phy. Concordance was higher for Co, with phy documenting a higher number of Co that can be objectively measured by lab values (diabetes, HTN) while pts reported higher rates of Co that were more subjective (anxiety, GERD). Overall, pts reported more Sx than phy. PR Sx were also the highest predictors of survival. Intriguingly, Co such as diabetes and HTN did not predict survival in this metastatic population. This suggests that incorporating PR Sx, either secondary to their cancer or related to their Co, may provide a more informative estimate of a pt’s predicted survival, and assist phy in evaluating trial eligibility and reasonable treatment options.

Variations in patient-reported outcome (PRO) collection and reporting in novel FDA approved anticancer therapies.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18202-e18202
Author(s):  
Surbhi Singhal ◽  
Evan Thomas Hall ◽  
Brooke Peterson Gabster ◽  
James Dickerson ◽  
Lidia Schapira
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Treatment ◽  
Treatment Options ◽  
Patient Reported Outcome ◽  
Cancer Therapies ◽  
Clinical Trial Registry ◽  
Fda Approval ◽  
Patient Reported ◽  
Anti Cancer

e18202 Background: Patient-reported outcomes (PROs) are increasingly valued as a key tool in patient-focused treatment decisions. However, a lack of standardization leads to significant variability in PRO collection and reporting in ground-breaking clinical trials of novel agents. We sought to characterize the mechanisms of assessment and variability by which PROs are reported for newly approved anti-cancer therapies. Methods: We reviewed the U.S. Food and Drug Administration (FDA) approvals between 2011 and 2017 for anti-cancer new molecular entities (NMEs) and new biologic approvals (BLAs). For each therapy, the pivotal clinical trial leading to FDA approval was identified using the national clinical trial (NCT) number and assessed for inclusion of PROs. A separate PubMed search was conducted to evaluate for PRO publication distinct from the original trial based on national clinical trial registry number. Results: From 2011 to 2017, the FDA approved 66 NMEs/BLAs based on 74 clinical trials for cancer treatment. Of the 74 clinical trial publications, 21 (28%) of the trials published PRO data in their original clinical publication, 18 (24%) published a separate PRO analysis, and 35 (47%) did not publish PRO data in either format. Among the 32 clinical trials (43%) that listed PROs as pre-specified outcomes, 72% published PROs (23/32). The separate PRO analyses (N = 18) were published considerably later following FDA approval (mean 605 days) than the original clinical trials (mean 20 days, N = 74, P < 0.001). Conclusions: As cancer treatment options expand, therapy decisions become increasingly nuanced. PROs assist decision-making by providing detailed information on important aspects of quality of life and tolerability. Our research has identified a significant lag in the publication of companion studies of PRO data associated with pivotal clinical trials, representing a meaningful gap in information critical to patients and oncologists in the process of making informed decisions.

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