Initial results of a new clinical trial matching service to increase patient participation

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17504-e17504
Author(s):  
T. Gansler ◽  
R. Comis ◽  
K. Sharpe ◽  
L. Tis ◽  
M. Jin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Call Center ◽  
Activity Level ◽  
Disease Stage ◽  
Trial Participation ◽  
Stage Disease ◽  
Enrollment Status ◽  
Enrollment Rates ◽  
Disease Site

e17504 Methods: Data from CTMS constituents and follow-up information describing enrollment status and barriers to trial participation are reviewed. Results: During 15 months of operation the CTMS provided information to 10,997 individuals; 7,521 (68.39%) used the website only, and 3,476 (31.61%) also contacted the ACS call center. Among 981 of the 3,476 (28.22% the basis of analyses below) who consented to and could be reached for follow-up and who answered the question on enrollment status, 119 (12.13%) enrolled in a CT. Trial phase was known for 74 enrollees (phase I: 17 [22.97%]; II: 36 [48.65%]; III: 21 [28.38%]; IV: 0 [0%]). Enrollment was negatively (p < 0.05) associated with poor ECOG functional status and black race, and was positively related to disease stage. Among the 757 individuals with available disease site and enrollment information, those with stomach cancer accounted for the most enrollments (25, 24.75% of all enrollments); followed by melanoma (12, 11.88%) and kidney, renal pelvis, bladder, ureter and urethra (also 12, 11.88%), and breast cancer (11, 10.89%). The highest enrollment rates (% enrollees among individuals with available follow-up) were for multiple myeloma/plasma cell disorders (4/14, 28.57%), melanoma (12/49, 24.49%), primary CNS malignancy (5/31, 16.13%), and soft tissue sarcoma (6/45, 13.33%). The following barriers were significantly associated with non-enrollment: ‘I cannot travel to clinical trial site,‘ ‘I cannot find a clinical trial using the modality or treatment I want,‘ ‘My physical activity level is too low,‘ and ‘I do not have measurable disease or am cancer-free.‘ Conclusions: 12% of CTMS participants with available follow-up data for enrollment status participated in a CT. Several determinants of CT participation were identified. Strategies for eliminating racial disparities, facilitating transportation, and increasing participation among patients with earlier stage disease and more common tumor types must be developed and implemented. No significant financial relationships to disclose.

American Cancer Society (ACS) clinical trial matching service (CTMS)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18501-18501
Author(s):  
T. Gansler ◽  
K. Sharpe ◽  
C. Demler ◽  
H. Eyre
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Call Center ◽  
Trial Participation ◽  
Cancer Type ◽  
Eligibility Criteria ◽  
Cancer Society ◽  
Lung Cancer Patients ◽  
Enrollment Rates ◽  
Low Prevalence

18501 Background: The low prevalence of clinical trial participation limits progress in clinical research and practice. ACS assists individuals in finding trials appropriate to their medical and personal situation. Methods: The ACS call center and website provide access to a comprehensive cancer clinical trial database and matching software platform licensed from EmergingMed. This report outlines characteristics and outcomes of constituents who met initial eligibility criteria and requested further information for at least one trial after entering data on their diagnosis and prior treatment. Results: Among 4525 CTMS constituents during 2004–5, 58% were patients, 40% were their relatives and 2% were friends. 62% entered data via the call center, the rest used www.cancer.org (although for quality assurance reasons, all must speak with a call center specialist before receiving trial site contact information). They requested protocols for a median of 6 trials (range 1 to 75); most often requesting information on trials for lung cancer (16.4%), breast cancer (11.4%), colorectal cancer (7.3%), prostate cancer (7.0%), and melanoma (5.2%). Likelihood of trial enrollment varied by cancer type (χ2, p < 0.0001) and was highest with kidney cancer (10.7%), melanoma (7.8%), multiple myeloma (4.4%), head & neck cancer (4.4%), and leukemia (3.8%). We studied several common cancer types in greater detail. For example, in analysis of data from 2004, non-small cell lung cancer patients requesting trial information had more advanced disease than typical patients in the National Cancer Database (χ2, p < 0.001). Enrollment rates for patients with stage I-IIIA and IIIB-IV were 0% and 3.7% (NS), respectively; rates for those with ECOG performance 0–1 and >1 were 4.8% and 0.0% (χ2, p < 0.05). Conclusions: The ACS CTMS can substantially augment participation in clinical trials among patients not recruited into trials by their oncologists. No significant financial relationships to disclose.

Dedicated clinical trial tissue tracking database to improve turn-around time at high-volume center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1543-1543
Author(s):  
Peter Blankenship ◽  
David DeLaRosa ◽  
Marc Burris ◽  
Steven Cusson ◽  
Kayla Hendricks ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Tissue Sample ◽  
High Volume ◽  
Trial Participation ◽  
Fresh Tissue ◽  
Oncology Clinical Trials ◽  
The Status ◽  
Unique Source

1543 Background: Tissue requirements in oncology clinical trials are increasingly complex due to prescreening protocols for patient selection and serial biopsies to understand molecular-level treatment effects. Novel solutions for tissue processing are necessary for timely tissue procurement. Based on these needs, we developed a Tissue Tracker (TT), a comprehensive database for study-related tissue tasks at our high-volume clinical trial center. Methods: In this Microsoft Access database, patients are assigned an ID within the TT that is associated with their name, medical record number, and study that follows their request to external users: pathology departments, clinical trial coordinators and data team members. To complete tasks in the TT, relevant information is required to update the status. Due to the high number of archival tissue requests from unique pathology labs, the TT has a “Follow-Up Dashboard” that organizes information needed to conduct follow-up on all archival samples with the status “Requested”. This results in an autogenerated email and pdf report sent to necessary teams. The TT also includes a kit inventory system and a real-time read only version formatted for interdepartmental communication, metric reporting, and other data-driven efforts. The primary outcome in this study was to evaluate our average turnaround time (ATAT: average time from request to shipment) for archival and fresh tissue samples before and after TT development. Results: Before implementing the TT, between March 2016 and March 2018, we processed 2676 archival requests from 235 unique source labs resulting in 2040 shipments with an ATAT of 19.29 days. We also processed 1099 fresh biopsies resulting in 944 shipments with an ATAT of 7.72 days. After TT implementation, between April 2018 and April 2020, we processed 2664 archival requests from 204 unique source labs resulting in 2506 shipments (+28.0%) with an ATAT of 14.78 days (-23.4%). During that same period, we processed 1795 fresh biopsies (+63.3%) resulting in 2006 shipments (+112.5%) with an ATAT of 6.85 days (-11.3%). Conclusions: Oncology clinical trials continue to evolve toward more extensive tissue requirements for prescreening and scientific exploration of on-treatment molecular profiling. Timely results are required to optimize patient trial participation. During the intervention period, our tissue sample volume and shipments increased, but the development and implementation of an automated tracking system allowed improvement in ATAT of both archival and fresh tissue. This automation not only improves end-user expectations and experiences for patients and trial sponsors but this allows our team to adapt to the increasing interest in tissue exploration.

scholarly journals Parental perspectives long term after neonatal clinical trial participation: a survey

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Thomas Salaets ◽  
Emilie Lavrysen ◽  
Anne Smits ◽  
Sophie Vanhaesebrouck ◽  
Maissa Rayyan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Participation ◽  
Drug Trials ◽  
Clinical Trial Participation ◽  
Parental Perspectives ◽  
Positive Experiences ◽  
Almost All

Abstract Background Although recruiting newborns is ethically challenging, clinical trials remain essential to improve neonatal care. There is a lack of empirical data on the parental perspectives following participation of their neonate in a clinical trial, especially at long term. The objective of this study is to assess experiences and emotions of parents, long term after trial participation in an interventional drug trial. Methods Parents of former participants of five neonatal interventional drug trials were surveyed at long term (3–13 years ago) after participation. The survey assessed parental contentment with trial participation, perceived influence of the trial on care and health, emotional consequences of participation, and awareness of typical clinical trial characteristics on 6-point Likert scales. Results Complete responses were received from 123 parents (52% of involved families). Twenty percent of parents did not remember participation. Those who remembered participation reported high contentment with overall trial participation (median 5.00), but not with follow-up (median 3.00). Most parents did not perceive any influence of the trial on care (median 2.00) and health (median 2.43). Almost all parents reported satisfaction and pride (median 4.40), while a minority of parents reported anxiety and stress (median 1.44) or guilt (median 1.33) related to trial participation. A relevant minority was unaware of typical trial characteristics (median 4.20; 27% being unaware). Conclusions Overall, parents reported positive experiences and little emotional distress long term after participation. Future efforts to improve the practice of neonatal clinical trials should focus on ensuring effective communication about the concept and characteristics of a clinical trial during consent discussions and on the follow-up after the trial.

Clinical trial awareness in oncology patients of diverse ethnic background: A single-institution analysis.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19217-e19217
Author(s):  
Gautam Valecha ◽  
Nishitha Thumallapally ◽  
Sandy El Bitar ◽  
Terenig O. Terjanian ◽  
Louise Madrigal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clin Oncol ◽  
Tumor Stage ◽  
Trial Participation ◽  
Cancer Clinical Trials ◽  
Single Institution ◽  
Staten Island ◽  
Enrollment Rates ◽  
Zip Code

e19217 Background: Clinical trials offer several advantages to the patients including access to innovative treatments with improved survival rates, closer monitoring and follow-up with removal of health disparity; and aim to advance the science of medicine. Yet, worldwide enrollment rates in cancer clinical trials have been only about 5 percent, despite the fact that a significantly higher percentage of Americans have a desire to participate in clinical trials [1, 2]. We conducted a single institution study to gain knowledge about clinical trial awareness in our cancer patient population as well as to identify the barriers within provider-consumer communication that prevent enrollment. Methods: A 10-question survey was distributed by medical assistants and surveys (n=222) were collected at the end of each clinic visit. Responders included racial/ethnic minorities and underserved patients, representative of the ethnic diversity in the Staten Island Borough of New York City. Demographic data including age, gender, zip code, race and ethnicity were recorded. Additionally, Charlson comorbidity index and tumor stage was also recorded. Results: 159/222 patients (71.62%) completed the survey. Of these patients, 47 (29.55%) answered every question on the survey, while 112/159 patients (70.44%) answered only few of the questions. The completed surveys are linked by zip code to the different boroughs of Staten Island, which allows us to identify hubs with lack of clinical trial awareness knowledge. Conclusions: Despite the several advantages for patients and medical field, enrollment rates in clinical trials remain very low. Our study results help in gaining knowledge about clinical trial awareness among oncology patients, correlated to comorbidity and tumor stage. In addition, demographic hubs with lack of knowledge are identified as targets for community outreach and education. A multilevel approach will be developed to address identified barriers that exist for patients, and will be implemented at community level, to reduce ethnic bias in trial enrollment and increase trial participation among an ethnically diverse population. References: 1. Unger JM, Cook E, Tai E, Bleyer A: The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. Am Soc Clin Oncol Educ Book. 2016, 35:185-198. 10.1200/EDBK_156686 2. Comis RL, Miller JD, Aldigé CR, Krebs L, Stoval E: Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003, 21:830-835. 10.1200/JCO.2003.02.105.

Management and Outcomes of Plasmablastic Lymphoma: A Single-Center Experience

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1483-1483
Author(s):  
Arjun Gupta ◽  
Harris V. Naina
Keyword(s):  
Overall Survival ◽  
Gastrointestinal Tract ◽  
Hiv Infection ◽  
Treatment Regimen ◽  
Median Survival ◽  
Plasmablastic Lymphoma ◽  
Disease Stage ◽  
Single Center ◽  
Stage Disease

Abstract Background: Plasmablastic lymphoma (PBL) is a rare aggressive B-cell neoplasm characteristically occurring in patients with HIV infection. Given their rarity, most of the existing literature is from case reports or heterogenous pooled data. Optimal therapy is not clearly defined and outcomes are traditionally poor with median survival in the order of months. We describe the epidemiology, management and outcomes of this rare malignancy at a single center. Methods: We identified patients with PBL diagnosed between 2000-2015 at Parkland Memorial Hospital. Patients were followed till June 2015. Structured forms were used to interview patients and to abstract relevant (demographics, diagnostics, pathology, therapy and outcomes) clinical data. Logistic regression was used to assess variables for association with the odds of treatment failure. Log-rank test was used to assess differences in survival by treatment regimen. Statistical analysis was performed using SAS software version 9.0 (SAS Institute). Results: Twenty-nine patients with PBL were diagnosed in the study period. Median age at presentation was 42 years; 24 (83%) were male. Twenty-sex (90%) occurred in patients with HIV infection; median CD4+ count at diagnosis was 93/mm3; median viral load was 97,823 copies/mL. Only 5 patients (17%) were actively taking antiretroviral therapy at the time of diagnosis. Three patients were immunocompetent. The most common primary site of disease was the gastrointestinal tract (13 patients) followed by oral/maxillofacial sites (10 patients). Twenty patients (69%) presented with adanced stage disease (stage III or IV disease). EBV was detected in all 26 cases where it was tested; HHV-8 was negative in all patients. CD20 positivity was seen in only 4 patients (14%). MYC rearrangements were described in 70% patients. EPOCH (etoposide, prednisolone, vincristine, cyclophosphamide and hydroxydaunorubicin), was the most common treatment regimen used in 16 patients (56%). Radiation therapy was administered in 28% of patients. Overall survival across the cohort was 9.9 months. Twenty patients (69%) died during the follow-up period; their median survival was 2.6 months. Nine patients were alive after a median follow-up of 47.8 months. Those who were treated with EPOCH demonstrated a better median overall survival compared to those who were not (26.3 months vs 1.2 months, p value 0.01). Conclusions: PBL is a rare AIDS-related lymphoma most commonly affecting the oral cavity and gastrointestinal tract. It mostly occurs in HIV patients not on HAART. Patients usually present with advanced stage disease. OS continues to be poor but EPOCH regimens can improve survival compared to non-EPOCH regimens, and should be further explored in this setting. Disclosures No relevant conflicts of interest to declare.

Overall survival of men with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line docetaxel-containing chemotherapy according to their participation (or not) in clinical trials.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 148-148
Author(s):  
Jatinder Goyal ◽  
Peng Huang ◽  
Prachi Tyagi ◽  
Daniel Oh ◽  
Michael Anthony Carducci ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Clinical Characteristics ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
First Line ◽  
Trial Participants ◽  
Baseline Hemoglobin

148 Background: There is insufficient evidence to determine whether clinical trial participation can itself lead to improved clinical outcomes in patients with mCRPC treated with docetaxel chemotherapy. We compared clinical characteristics and survival outcomes of patients with mCRPC receiving first-line docetaxel-containing therapy on a clinical study (trial participants) or outside of a clinical trial (non-participants). Methods: We retrospectively reviewed the records of 245 consecutive chemotherapy-naïve patients with mCRPC who received docetaxel-containing therapy between 1/1/1998 and 1/1/2010, either as trial participants (n=142; 11 separate studies) or as non-participants (n=103). Patient demographics, baseline clinical characteristics, treatment details and follow-up data were recorded. Results: In unadjusted analysis, trial participants were more likely to be white (83 vs 70%, p=0.005), to have better ECOG performance status (p=0.01), higher baseline hemoglobin (12.4 vs 11.6 g/dL, p=0.0003), higher albumin (4.3 vs 4.0 g/dL, p=0.009), lower creatinine (0.90 vs 1.04 mg/dL, p=0.01), and to have received a higher number of chemotherapy cycles (6.6 vs 5.1, p=0.001) than non-participants. In Kaplan-Meier analysis, median overall survival was significantly longer among trial participants vs non-participants (21.3 vs 17.1 months, p=0.024). In multivariable analysis, trial participation (HR 0.53, p=0.013), more chemotherapy cycles (HR 0.87; p=0.0002), baseline hemoglobin >12 g/dL (HR 0.67, p=0.016), lower ECOG score (HR 0.57, p=0.026) and lower baseline (log) PSA (HR 0.85, p=0.012) were all found to be independent predictors of survival. Conclusions: Clinical trial participation is an independent positive predictor of overall survival in men undergoing first-line docetaxel-containing chemotherapy for mCRPC. Improved survival in trial participants may reflect better medical oversight typically seen in patients enrolled in clinical trials, more regimented follow-up schedules, or a positive effect on caregivers’ attitudes due to greater contact with medical services.

scholarly journals The Role of Social Media in Enhancing Clinical Trial Recruitment: Scoping Review (Preprint)

2020 ◽  
Author(s):  
Ida Darmawan ◽  
Caitlin Bakker ◽  
Tabetha A Brockman ◽  
Christi A Patten ◽  
Milton Eder
Keyword(s):  
Clinical Trial ◽  
Social Media ◽  
Clinical Trials ◽  
Trial Participation ◽  
Trial Recruitment ◽  
Recruitment Methods ◽  
Enrollment Rates ◽  
Clinical Trial Recruitment ◽  
Use Of Social Media ◽  
Traditional Approaches

BACKGROUND Recruiting participants into clinical trials continues to be a challenge, which can result in study delay or termination. Recent studies have used social media to enhance recruitment outcomes. An assessment of the literature on the use of social media for this purpose is required. OBJECTIVE This study aims to answer the following questions: (1) How is the use of social media, in combination with traditional approaches to enhance clinical trial recruitment and enrollment, represented in the literature? and (2) Do the data on recruitment and enrollment outcomes presented in the literature allow for comparison across studies? METHODS We conducted a comprehensive literature search across 7 platforms to identify clinical trials that combined social media and traditional methods to recruit patients. Study and participant characteristics, recruitment methods, and recruitment outcomes were evaluated and compared. RESULTS We identified 2371 titles and abstracts through our systematic search. Of these, we assessed 95 full papers and determined that 33 studies met the inclusion criteria. A total of 17 studies reported enrollment outcomes, of which 9 achieved or exceeded their enrollment target. The proportion of participants enrolled from social media in these studies ranged from 0% to 49%. Across all 33 studies, the proportion of participants recruited and enrolled from social media varied greatly. A total of 9 studies reported higher enrollment rates from social media than any other methods, and 4 studies reported the lowest cost per enrolled participant from social media. CONCLUSIONS While the assessment of the use of social media to improve clinical trial participation is hindered by reporting inconsistencies, preliminary data suggest that social media can increase participation and reduce per-participant cost. The adoption of consistent standards for reporting recruitment and enrollment outcomes is required to advance our understanding and use of social media to support clinical trial success.

scholarly journals The Role of Social Media in Enhancing Clinical Trial Recruitment: Scoping Review

10.2196/22810 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e22810
Author(s):  
Ida Darmawan ◽  
Caitlin Bakker ◽  
Tabetha A Brockman ◽  
Christi A Patten ◽  
Milton Eder
Keyword(s):  
Clinical Trial ◽  
Social Media ◽  
Clinical Trials ◽  
Trial Participation ◽  
Trial Recruitment ◽  
Recruitment Methods ◽  
Enrollment Rates ◽  
Clinical Trial Recruitment ◽  
Use Of Social Media ◽  
Traditional Approaches

Background Recruiting participants into clinical trials continues to be a challenge, which can result in study delay or termination. Recent studies have used social media to enhance recruitment outcomes. An assessment of the literature on the use of social media for this purpose is required. Objective This study aims to answer the following questions: (1) How is the use of social media, in combination with traditional approaches to enhance clinical trial recruitment and enrollment, represented in the literature? and (2) Do the data on recruitment and enrollment outcomes presented in the literature allow for comparison across studies? Methods We conducted a comprehensive literature search across 7 platforms to identify clinical trials that combined social media and traditional methods to recruit patients. Study and participant characteristics, recruitment methods, and recruitment outcomes were evaluated and compared. Results We identified 2371 titles and abstracts through our systematic search. Of these, we assessed 95 full papers and determined that 33 studies met the inclusion criteria. A total of 17 studies reported enrollment outcomes, of which 9 achieved or exceeded their enrollment target. The proportion of participants enrolled from social media in these studies ranged from 0% to 49%. Across all 33 studies, the proportion of participants recruited and enrolled from social media varied greatly. A total of 9 studies reported higher enrollment rates from social media than any other methods, and 4 studies reported the lowest cost per enrolled participant from social media. Conclusions While the assessment of the use of social media to improve clinical trial participation is hindered by reporting inconsistencies, preliminary data suggest that social media can increase participation and reduce per-participant cost. The adoption of consistent standards for reporting recruitment and enrollment outcomes is required to advance our understanding and use of social media to support clinical trial success.

scholarly journals Neopterin and CXCL-13 in Diagnosis and Follow-Up of Trypanosoma brucei gambiense Sleeping Sickness: Lessons from the Field in Angola

2019 ◽  
Vol 2019 ◽  
pp. 1-9
Author(s):  
Julien Bonnet ◽  
Philippe Vignoles ◽  
Natalia Tiberti ◽  
Vatunga Gedeão ◽  
Alexandre Hainard ◽  
...  
Keyword(s):  
Human African Trypanosomiasis ◽  
Intermediate Stage ◽  
Disease Stage ◽  
Advanced Stage ◽  
Trypanosoma Brucei Gambiense ◽  
Neopterin Concentration ◽  
Stage Disease ◽  
Stage 1 ◽  
Work Supports

Human African Trypanosomiasis may become manageable in the next decade with fexinidazole. However, currently stage diagnosis remains difficult to implement in the field and requires a lumbar puncture. Our study of an Angolan cohort of T. b. gambiense-infected patients used other staging criteria than those recommended by the WHO. We compared WHO criteria (cell count and parasite identification in the CSF) with two biomarkers (neopterin and CXCL-13) which have proven potential to diagnose disease stage or relapse. Biological, clinical, and neurological data were analysed from a cohort of 83 patients. A neopterin concentration below 15.5 nmol/L in the CSF denoted patients with stage 1 disease, and a concentration above 60.31 nmol/L characterized patients with advanced stage 2 (trypanosomes in CSF and/or cytorachia higher than 20 cells) disease. CXCL-13 levels below 91.208 pg/mL denoted patients with stage 1 disease, and levels of CXCL-13 above 395.45 pg/mL denoted patients with advanced stage 2 disease. Values between these cut-offs may represent patients with intermediate stage disease. Our work supports the existence of an intermediate stage in HAT, and CXCL-13 and neopterin levels may help to characterize it.

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