Factors associated with patients' loss to follow-up after finishing randomized clinical trial participation

2004 ◽  
Author(s):  
I STRUSBERG ◽  
A BERTOLI ◽  
M RAMOS ◽  
G FIERRO ◽  
R PIZZOLATO ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Loss To Follow Up ◽  
Factors Associated

Factors associated with patients' loss to follow-up after finishing randomized clinical trial participation

2005 ◽  
Vol 26 (1) ◽  
pp. 38-44 ◽  
Author(s):  
Ingrid Strusberg ◽  
Ana M. Bertoli ◽  
Mariela Ramos ◽  
Gonzalo Fierro ◽  
Ruth Pizzolato ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Loss To Follow Up ◽  
Factors Associated

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.

Factors associated with clinical trial participation for patients with prostate cancer.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 96-96
Author(s):  
Brian Shinder ◽  
Sinae Kim ◽  
Hiren V. Patel ◽  
Arnav Srivastava ◽  
Tina M. Mayer ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Stage ◽  
Research Participation ◽  
Sociodemographic Factors ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Factors Associated ◽  
Trial Participants

96 Background: Clinical trials are critical for the development of new treatment paradigms for Prostate Cancer (PCa). The primary aim of this study was to characterize the factors associated with clinical trial participation for patients with PCa. The secondary objective was to examine survival outcomes in the clinical trial and control cohorts. Methods: The National Cancer Database (NCDB) was queried for patients with PCa who were coded as having enrolled in a clinical trial. Trial patients were matched in a 1:8 ratio to controls based on clinical stage. Sociodemographic variables were compared between the two groups and univariate and multivariate logistic regression models evaluated factors associated with clinical trial participation. Kaplan-Meier product limit estimate was used to compare overall survival (OS) between the groups. Results: From 2004-2015, 495 patients enrolled in clinical trials were included for analysis. The mean age of trial patients was 63.2 compared to 66.4 in the matched cohort (p < 0.0001). More patients in the trial group had a Charlson-Deyo comorbidity score of 0 (89.3% vs. 82.1%, p = 0.0002). On multivariate analysis, patients who traveled between 50-250 miles (OR 1.59; 95%CI 1.15-2.19, p = 0.005) or came from a zip code where greater than 93% of the population has a high school degree (OR 4.97; 95%CI 2.89-8.54, p < 0.0001) were more likely to participate in a clinical trial. There was no association between race and insurance status on clinical trial participation. Median OS was not significantly different among clinical trial participants than the control cohort (120.9 months vs. not reached, p = 0.928). Conclusions: In this contemporary analysis of PCa patients from a national hospital registry database, we found that certain patient sociodemographic factors remain associated with clinical trial participation, though clinical trial participants do not seem to experience a difference in OS. Further work, both qualitative and quantitative, is necessary to identify clinical and non-clinical barriers to research participation in order to improve the validity of PCa trials.

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 Decision-Making Issues for Randomized Clinical Trial Participation among Hispanics

2003 ◽  
Vol 10 (5_suppl) ◽  
pp. 84-86 ◽  
Author(s):  
Lee Ellington ◽  
Stephanie Wahab ◽  
Shadi Sahami ◽  
Rosemary Field ◽  
Kathi Mooney
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Randomized Clinical Trial ◽  
Trial Participation ◽  
Clinical Trial Participation

scholarly journals Follow-Up of Food-Allergic Patients Transitioned to Daily Ingestion of Real Food Equivalents after Clinical Trial Participation

2020 ◽  
Vol 145 (2) ◽  
pp. AB135
Author(s):  
Amanda Cox ◽  
Mary Grace Baker ◽  
Jake Kattan ◽  
Marion Groetch ◽  
Allison Schaible ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Daily Ingestion

Factors associated with clinical trial participation for patients with renal cell carcinoma.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 670-670
Author(s):  
Brian Shinder ◽  
Sinae Kim ◽  
Arnav Srivastava ◽  
Hiren V. Patel ◽  
Tina M. Mayer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Clinical Trials ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Clinical Stage ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Factors Associated ◽  
Trial Participants

670 Background: Clinical trials are critical for the development of new treatment paradigms for renal cell carcinoma (RCC). The primary objective of this study was to characterize the factors associated with clinical trial participation for patients with RCC. The secondary objective was to examine survival outcomes in the clinical trial and control cohorts. Methods: The National Cancer Database (NCDB) was queried for patients with RCC who were coded as having enrolled in a clinical trial. Trial patients were matched in a 1:5 ratio to controls from the same institution based on clinical stage. Sociodemographic variables were compared between the two groups and univariate and multivariate logistic regression models evaluated factors associated with clinical trial participation. Kaplan-Meier product limit estimate was used to compare overall survival (OS) between the groups. Results: From 2004-2015, 681 patients enrolled in clinical trials were included for analysis. The mean age of trial patients was 56.4 compared to 62 in the matched cohort (p<0.0001). More patients in the trial group had a Charlson-Deyo comorbidity score of 0 (81.6% vs. 73.9%, p<0.0001). On multivariate analysis, male patients (OR 1.27; 95%CI 1.06-1.54, p=0.012) and white patients (OR 1.88, 95%CI 1.23-2.87; p=0.003) were more likely to participate in a trial. Having Medicaid (OR 0.42; 95%CI 0.27-0.64; p<0.0001) or Medicare (OR 0.6; 95%CI 0.46-0.77; p<0.0001) was negatively associated with clinical trial participation. Median OS was greater among clinical trial participants than that the control cohort (106.61 vs 87.62 months, p<0.0001). Conclusions: In this contemporary analysis of RCC patients from a national hospital registry database, we found that patient sociodemographic factors remain associated with clinical trial participation and that clinical trial participants experienced superior OS. Further work, both qualitative and quantitative, is necessary to identify clinical and non-clinical barriers to research participation in order to improve the validity of RCC trials.

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