Cognitive technology addressing optimal cancer clinical trial matching and protocol feasibility in a community cancer practice.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6501-6501 ◽  
Author(s):  
J. Thaddeus Beck ◽  
Michael Vinegra ◽  
Irene Dankwa-Mullan ◽  
Adam Torres ◽  
Courtney C Simmons ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Language Processing ◽  
Patient Characteristics ◽  
Cognitive Computing ◽  
Breast Cancer Patients ◽  
Exclusion Criteria ◽  
Staff Members ◽  
Ibm Watson ◽  
Oncology Practice

6501 Background: IBM Watson for Clinical Trial Matching (CTM) is a cognitive computing solution that uses natural language processing (NLP) to help increase the efficiency and accuracy of the clinical trial matching process. This solution helps providers locate suitable protocols for their patients by reading the trial criteria and matching it to the structured and unstructured patient characteristics when integrated with the Electronic Medical Record (EMR). It is also designed to determine which sites have the most viable patient population and identify inclusion and exclusion criteria that limit enrollment. Methods: This project was a collaboration among Highlands Oncology Group (HOG), Novartis and IBM Watson Health to explore the use of CTM in a community oncology practice. HOG is in Northeast Arkansas and has 15 physicians and 310 staff members working across 3 sites. During the 16-week pilot period, data from 2,620 visits by lung and breast cancer patients were processed by the CTM system. Using NLP capabilities, CTM read the clinical trial protocols provided by Novartis, and evaluated the patient data against the protocols’ inclusion and exclusion criteria. Watson excluded ineligible patients, determined those that needed further screening, and assisted in that process. Feedback on the user experience was also obtained. Results: In an initial pre-screening test, the HOG clinical trial coordinator (CTC) took 1 hour and 50 minutes to process 90 patients against 3 breast cancer protocols. Conversely, when the CTM screening solution was used, it took 24 minutes. This represents a significant reduction in time of 86 minutes or 78%. Watson excluded 94% of the patients automatically, providing criteria level evidence regarding the reason for exclusion, thus reducing the screening workload dramatically. Conclusions: IBM Watson CTM can help expedite the screening of patient charts for clinical trial eligibility and therefore may also help determine the feasibility of protocols to optimize site selection and enable higher and more efficient trial accruals.

scholarly journals Electronic Moxibustion for Breast Cancer-Related Lymphedema: A Pilot Clinical Trial

2020 ◽  
Vol 19 ◽  
pp. 153473542096285
Author(s):  
Kyungsun Han ◽  
Ojin Kwon ◽  
Hyo-Ju Park ◽  
Ae-Ran Kim ◽  
Boram Lee ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Range Of Motion ◽  
Upper Limb ◽  
Life Questionnaire ◽  
Breast Cancer Patients ◽  
Shoulder Range Of Motion ◽  
Breast Cancer Related Lymphedema ◽  
Shoulder Range

This is a preliminary study to investigate the feasibility of electronic moxibustion in breast cancer patients with upper limb lymphedema. As current treatment options for lymphedema are unsatisfactory and time consuming, there have been attempts to manage symptoms using integrative treatments. Electronic moxibustion was developed to compensate for the shortcomings of conventional moxibustion and is widely used in clinical practice. However, there have been no studies on using electronic moxibustion in breast cancer-related lymphedema. To investigate the feasibility of electronic moxibustion in treating breast cancer-related lymphedema, this study included subjects who completed primary cancer treatment at least 6 months ago and had more than 10 mm difference in arm circumference of upper limbs. All subjects were assigned to the treatment group. Subjects were treated with 16 sessions (30 minutes/session) of electronic moxibustion for 8 weeks followed by 4 weeks of follow-up. For outcome measures, upper limb circumferences, shoulder range of motion, bioimpedance analysis, and quality of life questionnaire were assessed. All 10 subjects completed the study. The effective index showed 38.21% reduction after treatment ( P = .0098) and 29.35% ( P = .0039) after 4 weeks of follow-up compared to the baseline. The reduction of lymphedema was most prominent at 10 cm above the elbow crease, where the mean reduction of circumference difference was 7.5 mm ( P = .0430) and continued to improve after treatment (mean reduction of 8.3 mm, P = .0156). There was significant improvement in shoulder range of motion only in flexion and internal rotation at week 9. There were 7 adverse events, and most were irrelevant to the treatment. Only 1 participant had a mild burn on the acupuncture point. Here, we demonstrate for the first time that electronic moxibustion treatment is a feasible treatment for breast cancer-related lymphedema. Electronic moxibustion may reduce differences in upper limb circumference and improve shoulder range of motion. A future comparative clinical trial is needed to confirm the clinical efficacy of this treatment.

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

scholarly journals Hospital Processes and the Nurse-Patient Interaction in Breast Cancer Care. Findings from a Cross-Sectional Study

2021 ◽  
Vol 18 (15) ◽  
pp. 8224
Author(s):  
Johanna Sophie Lubasch ◽  
Susan Lee ◽  
Christoph Kowalski ◽  
Marina Beckmann ◽  
Holger Pfaff ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Social Support ◽  
Cancer Patients ◽  
Perceived Social Support ◽  
Patient Characteristics ◽  
Patient Survey ◽  
Breast Cancer Patients ◽  
Cross Sectional ◽  
Patient Interaction ◽  
Hospital Structures

(1) Background: Evidence suggests that organizational processes of hospitals have an impact on patient-professional interactions. Within the nurse-patient interaction, nurses play a key role providing social support. Factors influencing the nurse-patient interaction have seldomly been researched. We aimed to examine whether the process organization in hospitals is associated with breast cancer patients’ perceived social support from nurses.; (2) Methods: Data analysis based on a cross-sectional patient survey (2979 breast cancer patients, 83 German hospitals) and information on hospital structures. Associations between process organization and perceived social support were analyzed with logistic hierarchical regression models adjusted for patient characteristics and hospital structures.; (3) Results: Most patients were 40–69 years old and classified with UICC stage II or III. Native language, age and hospital ownership status showed significant associations to the perception of social support. Patients treated in hospitals with better process organization at admission (OR 3.61; 95%-CI 1.67, 7.78) and during the hospital stay (OR 2.11; 95%-CI 1.04; 4.29) perceived significantly more social support from nurses.; (4) Conclusions: Designing a supportive nursing work environment and improving process organization in hospitals may create conditions conducive for a supportive patient-nurse interaction. More research is needed to better understand mechanisms behind the associations found.

Randomized clinical trial of tamoxifen alone or combined with fluoxymesterone in postmenopausal women with metastatic breast cancer.

1988 ◽  
Vol 6 (5) ◽  
pp. 825-831 ◽  
Author(s):  
J N Ingle ◽  
D I Twito ◽  
D J Schaid ◽  
S A Cullinan ◽  
J E Krook ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Side Effects ◽  
Postmenopausal Women ◽  
Randomized Clinical Trial ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Rank Test ◽  
Breast Cancer Patients

A randomized clinical trial was performed to determine if combination hormonal therapy with tamoxifen (TAM) and fluoxymesterone (FLU) was more efficacious than TAM alone for the treatment of postmenopausal women with metastatic breast cancer. Patients failing TAM could subsequently receive FLU. The dose of both drugs was 10 mg orally twice daily. Objective responses were seen in 50 of 119 TAM patients (42%) and 63 of 119 TAM plus FLU patients (53%) (one-sided P = .05). Time to disease progression distributions were better for TAM plus FLU (median, 350 days v 199 days), but the log rank test only approached statistical significance (one-sided P = .07). Duration of response and survival distributions were similar between the two treatment arms. Toxicities, in terms of androgenic side effects, were greater on the TAM plus FLU regimen. Fifty-two patients are evaluable for response with FLU following TAM and 21 (40%) have achieved a response. We conclude that the advantages in terms of response rate and time to progression observed with TAM plus FLU probably represent a biological effect, but are not of sufficient magnitude to justify the routine clinical use of this combination given the lack of survival advantage and side effects encountered.

Artificial Intelligence Tool for Optimizing Eligibility Screening for Clinical Trials in a Large Community Cancer Center

2020 ◽  
pp. 50-59 ◽  
Author(s):  
J. Thaddeus Beck ◽  
Melissa Rammage ◽  
Gretchen P. Jackson ◽  
Anita M. Preininger ◽  
Irene Dankwa-Mullan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Language Processing ◽  
Medical Records ◽  
Cancer Center ◽  
Patients With Cancer ◽  
Attribute Extraction ◽  
Time Required ◽  
Manual Review

PURPOSE Less than 5% of patients with cancer enroll in clinical trials, and 1 in 5 trials are stopped for poor accrual. We evaluated an automated clinical trial matching system that uses natural language processing to extract patient and trial characteristics from unstructured sources and machine learning to match patients to clinical trials. PATIENTS AND METHODS Medical records from 997 patients with breast cancer were assessed for trial eligibility at Highlands Oncology Group between May and August 2016. System and manual attribute extraction and eligibility determinations were compared using the percentage of agreement for 239 patients and 4 trials. Sensitivity and specificity of system-generated eligibility determinations were measured, and the time required for manual review and system-assisted eligibility determinations were compared. RESULTS Agreement between system and manual attribute extraction ranged from 64.3% to 94.0%. Agreement between system and manual eligibility determinations was 81%-96%. System eligibility determinations demonstrated specificities between 76% and 99%, with sensitivities between 91% and 95% for 3 trials and 46.7% for the 4th. Manual eligibility screening of 90 patients for 3 trials took 110 minutes; system-assisted eligibility determinations of the same patients for the same trials required 24 minutes. CONCLUSION In this study, the clinical trial matching system displayed a promising performance in screening patients with breast cancer for trial eligibility. System-assisted trial eligibility determinations were substantially faster than manual review, and the system reliably excluded ineligible patients for all trials and identified eligible patients for most trials.

scholarly journals Consumption of Fresh Yellow Onion Ameliorates Hyperglycemia and Insulin Resistance in Breast Cancer Patients During Doxorubicin-Based Chemotherapy: A Randomized Controlled Clinical Trial

2016 ◽  
Vol 16 (3) ◽  
pp. 276-289 ◽  
Author(s):  
Farnaz Jafarpour-Sadegh ◽  
Vahid Montazeri ◽  
Ali Adili ◽  
Ali Esfehani ◽  
Mohammad-Reza Rashidi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Insulin Resistance ◽  
Clinical Trial ◽  
Ductal Carcinoma ◽  
Fasting Blood Glucose ◽  
Controlled Clinical Trial ◽  
Random Allocation ◽  
Breast Cancer Patients ◽  
Care Givers

Purpose. Doxorubicin has been found to be associated with insulin resistance in animal models. Onion, a so-called functional food, is noted to affect the insulin signaling pathway of diabetes in vitro. To our knowledge, this is the first study to investigate the effects of consuming fresh yellow onions on insulin-related indices compared with a low–onion-containing diet among breast cancer (BC) patients treated with doxorubicin. Methods. This parallel-design, randomized, triple-blind, controlled clinical trial was conducted on 56 eligible BC patients (aged 30-63 years), diagnosed with invasive ductal carcinoma. Following their second cycle of chemotherapy, subjects were assigned in a stratified-random allocation to receive body mass index–dependent 100 to 160 g/d of onion as high onion group (HO; n = 28) or 30 to 40 g/d small onions in low onion group (LO; n = 28) for 8 weeks intervention. Participants, care givers, and those who assessed laboratory analyses were blinded to the assignments (IRCT Registry No.: IRCT2012103111335N1). Results. The compliance level of participants in the analysis was as high as 87.85%. A total of 23 available cases was analyzed in each group. The daily use of HO resulted in a significant decrease in serum fasting blood glucose and insulin levels in comparison with LO, over the period of study ( P < .001). Posttreatment with HO showed a significant decrease in homeostasis model of assessment-insulin resistance relative to changes in the LO group ( P < .05). A comparison of the changes that occurred throughout pre- and postdose treatments indicated improved quantitative insulin sensitivity check index ( P < .05) and controls on C-peptide in the HO group ( P < .05). Conclusions. The present study demonstrated the effectiveness of onion to ameliorate hyperglycemia and insulin resistance in BC during doxorubicin-based chemotherapy.

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