Nationally representative estimates of the participation of cancer patients in clinical research studies according to the commission on cancer.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 74-74
Author(s):  
Joseph M. Unger ◽  
Mark Fleury
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Clinical Research ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Cancer Centers ◽  
Treatment Trials ◽  
Nationally Representative ◽  
Enrollment Data

74 Background: The successful conduct of cancer clinical trials hinges on the willingness of patients to participate. The rate of adult clinical trial participation has been regarded as being < 5%. However, national estimates of trial participation are nearly two decades old, and no evidence based on original data sources has been examined for many years. Moreover, studies about trial participation have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other key elements of clinical research, such as quality of life or biorepository studies. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from 1,200 institutions. Methods: The data were from the Commission on Cancer (CoC), a consortium of cancer-related organizations providing accreditation for both academic and community cancer care facilities across the U.S. CoC enrollment data represent 70% of all cases of cancer diagnosed each year. Deidentified, institution-level aggregate counts of annual enrollment to treatment, biorepository, diagnostic, economic, genetic, prevention, quality of life, registry, and screening studies were examined. Overall, study-type estimates for the period 2013-2017 were estimated. Multiple imputation by chained equations was used to account for missing data, with summary estimates calculated separately by type of program (e.g., NCI-designated cancer programs) and pooled. Results: Across the entire U.S. system, the estimated participation rate to cancer treatment trials was 6.3%. Enrollment to treatment trials was highest at NCI-designated comprehensive cancer centers (18.9%), while for community cancer programs (CCPs) and comprehensive CCPs, treatment trial rates were 4.4% and 3.6%, respectively. Nearly 1 in 7 patients participated in biorepository studies (13.4%), including 39.4% at NCI cancer centers. Patients participated in a wide variety of other study types, including registry (8.1%), prevention (6.4%), genetic (3.6%), quality of life (2.9%), economic (2.7%), diagnostic (2.7%), and screening studies (1.8%). At least 25.4% of adult cancer patients were estimated to participate in one or more cancer clinical research studies. Conclusions: In a first-time use of nationally representative enrollment data from the CoC, enrollment to cancer treatment trials was 6.3%, higher than historical estimates of < 5%. Patients participated in a diverse set of other study types, and taken together, at least one quarter of patients participated in a study. Contributions of adult patients with cancer to clinical research is much more comprehensive than previously understood.

scholarly journals Challenges to National Cancer Institute–Supported Cooperative Group Clinical Trial Participation: An ASCO Survey of Cooperative Group Sites

2010 ◽  
Vol 6 (3) ◽  
pp. 114-117 ◽  
Author(s):  
Allison R. Baer ◽  
Chelsey A. Kelly ◽  
Suanna S. Bruinooge ◽  
Carolyn D. Runowicz ◽  
Douglas W. Blayney
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
National Cancer Institute ◽  
Trial Participation ◽  
Cooperative Group ◽  
Clinical Trial Participation ◽  
Anecdotal Information

Anecdotal information regarding clinical research sites limiting participation in NCI-funded cooperative group studies prompted ASCO to collect data on and investigate the reasons behind this trend.

scholarly journals Who Needs What? Perceptions of Patients and Caregivers in Oncology Phase 1 Trials

2019 ◽  
Vol 7 (1) ◽  
pp. 27-33 ◽  
Author(s):  
Victoria Rezash ◽  
Janice Reed ◽  
Barbara Gedeon ◽  
Eric Parsons ◽  
Sandra Siedlecki ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase 1 ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Oncology Clinical Trial ◽  
Oncology Clinical Trials ◽  
Vulnerable Patient ◽  
Additional Support

Background: The study design and nature of oncology phase 1 clinical trials create a uniquely vulnerable patient population yet little research has been conducted to identify the added burden these trials create for both cancer patients and their caregiver(s). Objective: Examining the perceptions and needs of patients and their caregivers participating in phase 1 oncology clinical trials, the investigators tested the hypothesis that the caregiver will exhibit a higher level of burden and/or distress than the patient. Method: A mixed-methods exploratory process utilizing patient and caregiver interviews and quality-of-life questionnaires was used to assess the psychosocial burdens associated with oncology clinical trial participation. A qualitative and quantitative analysis of the responses were 8 performed. Result: Both patients and caregivers reported similar themes identifying the burdens and benefits related to phase 1 clinical trial participation. However, the caregivers’ expressed burden exceeded that of the patients’ validating the study’s hypothesis. Conclusion: The need for ongoing additional support services for not only the patient but also the caregiver was identified.

Measuring quality of life in dementia: purposes, goals, challenges and progress

2007 ◽  
Vol 19 (3) ◽  
pp. 401-407 ◽  
Author(s):  
Peter V. Rabins ◽  
Betty S. Black
Keyword(s):  
Quality Of Life ◽  
Clinical Research ◽  
Cognitive Capacities ◽  
Treatment Trials ◽  
Clinical Meaningfulness

The choice of outcomes in clinical research should be influenced by a linkage between the targeted symptom or disorder and the outcome being measured, the clinical meaningfulness of the outcome, and the ability to measure the outcome accurately. Dementia, defined as a syndrome consisting of disorders that impair two or more distinct cognitive capacities, occur in clear consciousness, and begin in adulthood, presents unique challenges in the choice of appropriate outcomes for treatment trials.

scholarly journals Understanding the Barriers to Pediatric Oncologist Engagement and Accrual to Clinical Trials in National Cancer Institute–Designated Community Oncology Research Programs

2020 ◽  
pp. JOP.19.00707 ◽  
Author(s):  
David S. Dickens ◽  
Michael E. Roth ◽  
Brad H. Pollock ◽  
Anne-Marie Langevin
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
National Cancer Institute ◽  
Time Allocation ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Clinical Trial Research ◽  
Protected Time ◽  
Oncology Research ◽  
Community Oncology

PURPOSE: Clinical trial participation leads to progress in cancer care. Principal investigators (PIs) and clinical research associates (CRAs) play key roles in the provision and maintenance of clinical trial portfolios at their sites. Previous studies have evaluated the educational and resource needs of adult oncology providers, but nothing to date has focused on providers of pediatric oncology care. We aimed to identify the educational needs and clinical trial participation barriers at National Cancer Institute Community Oncology Research Program (NCORP) Children’s Oncology Group (COG) sites to improve the quality of site investigator engagement. METHODS: Quality improvement surveys of pediatric clinical research staff at NCORP sites were performed. The first was a web-based inquiry of NCORP COG PIs and lead CRAs to assess their general understanding of NCORP organizational structure and needs. The second survey of COG PIs was conducted by one-on-one telephone interviews aimed at identifying specific barriers to physician engagement and patient enrollment in clinical trial research. RESULTS: The majority of NCORP COG PIs and CRAs (63%) reported an incomplete understanding of NCORP structure, with approximately half expressing interest in developing stronger collaborations and engagement. Most NCORP COG PIs reported at least one shared barrier to clinical trial enrollment (78%), with inadequate protected time and research support (39% each) being the most frequently cited barriers. CONCLUSIONS: Contributions to pediatric cancer clinical research at COG NCORP sites could be enhanced through improved education, resources, and time allocation.

Telemedicine-enabled clinical trial of metformin in patients (pts) with biochemically-recurrent prostate cancer (PCa).

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 243-243
Author(s):  
Matt D. Galsky ◽  
Mohamed Shahin ◽  
Ashley Olson ◽  
David R. Shaffer ◽  
Kiev Gimpel-Tetra ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Local Therapy ◽  
Smartphone Application ◽  
Primary Objective ◽  
Trial Participation ◽  
Driving Time ◽  
Oncology Clinical Trial ◽  
Grade 3

243 Background: Clinical trials are critical to informing cancer care but are hampered by slow accrual and suboptimal generalizability, both contributed to by poor geographic accessibility. We previously reported that > 50% of the US population resides > 1 hour from the nearest PCa clinical trial site (Galsky, JAMA Int Med, 2015). We sought to test the feasibility of replacing on-site study visits with telemedicine visits in a prospective clinical trial. Methods: Castration-naïve non-metastatic pts with PCa and a rising PSA after local therapy were eligible. Pts required a single on-site visit for enrollment. Treatment consisted of metformin 850 mg QD x 1 month followed by 850 mg BID x 5 months. Telemedicine visits were conducted monthly using a HIPAA-compliant smartphone application. The primary objective was to determine feasibility defined as completion of all eligible telemedicine visits by > 2/3 enrolled pts; pts were ineligible for future telemedicine visits if treatment discontinued early for toxicity or disease progression. Secondary objectives included safety, % patients with ≤ 20% PSA rise at 6 months, quality of life, and patient satisfaction. Results: 15 pts were enrolled, median age 68 (range, 57, 83), one-way driving time 1.3 hours (range, 0.2-2.8), Gleason score 7 (range, 6, 9), and pre-study PSA 4.1 (range, 0.52, 31.7). The 6 month course of metformin was completed by 11/15 (73%) pts; 2 discontinued early due to rising PSA, 1 due to adverse event (AE), and 1 remains on study. Excluding 1 pt still on study, 14/14 (100%; 95% CI 76, 100) pts completed all 78 eligible telemedicine visits. The most common AEs were diarrhea (grade 1 = 60%) and fatigue (grade 1 = 20%); 1 pt experienced grade ≥ 3 AE (dehydration). The 6-month PSA was ≤ 20% baseline in 1 pt; median % PSA change at last televisit was +52.8% (range, -3.0, +318.8). Quality of life and pt satisfaction will be reported at the meeting. Conclusions: To our knowledge, this is the first ever interventional oncology clinical trial conducted via telemedicine. Telemedicine-enabled trials are feasible and may overcome barriers to trial participation. Metformin was generally well tolerated but associated with minimal anti-PCa activity as measured by PSA. Clinical trial information: NCT02376166.

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