Effect of 9–11 on U.S. national cancer clinical trials accrual and lack of effect of National Cancer Institute budget increases

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6551-6551 ◽  
Author(s):  
A. Bleyer

6551 Background: During the past decade, a variety of initiatives have been implemented to improve the accrual of cancer patients on clinical trials. In the U.S., these have included comprehensive reviews and recommendations by the two most recent National Cancer Institute (NCI) administrations, reorganization of the clinical trials infrastructure at the NCI, and campaigns by the NCI Cooperative Groups and their Coalition. During the past six years, additional funds were allocated to this effort as part of the doubling of the NCI budget. The impact of these efforts on national cancer treatment clinical trials was evaluated, with emphasis on age groups. Methods: Accrual data from NCI-sponsored treatment trials conducted between 1997 and 2006 were obtained from the NCI Cancer Therapy Evaluation Program. Entries were analyzed by patient age, gender, race, type of cancer treated, and calendar year of trial entry. Results: Overall, national cancer treatment trial entries declined after 9–11–2001 and in 2003 reached the lowest levels since 1997. As of 2005 accrual recovered to pre 9–11 levels only in 15–29 and >60 year-olds, with the former demonstrating the greatest gain ( Table ). Entries among <15 and 30–49 year- olds declined steadily since 1997 with no evidence for recovery as of 2005 ( Table ). Overall, the estimated proportion of the nation's cancer patients entered onto national treatment trials remains below 3%. Conclusions: Despite continued national and local efforts to increase the participation of cancer patients on clinical trials, accompanied by significant increases in the NIH and NCI budgets, there is little evidence of a beneficial impact. The effect of 9–11 has yet to be overcome, except in young and elderly adults, in whom specific, targeted initiatives appear to have been successful. The latter approaches may be useful to apply to other age groups, particularly in view of the recent cuts in the cooperative group budgets and current mandated decreases in study accruals. No significant financial relationships to disclose. [Table: see text]

2002 ◽  
Vol 20 (8) ◽  
pp. 2109-2117 ◽  
Author(s):  
Warren B. Sateren ◽  
Edward L. Trimble ◽  
Jeffrey Abrams ◽  
Otis Brawley ◽  
Nancy Breen ◽  
...  

PURPOSE: We chose to examine the impact of socioeconomic factors on accrual to National Cancer Institute (NCI)–sponsored cancer treatment trials. PATIENTS AND METHODS: We estimated the geographic and demographic cancer burden in the United States and then identified 24,332 patients accrued to NCI-sponsored cancer treatment trials during a 12-month period. Next, we examined accrual by age, sex, geographic residence, health insurance status, health maintenance organization market penetration, several proxy measures of socioeconomic status, the availability of an oncologist, and the presence of a hospital with an approved multidisciplinary cancer program. RESULTS: Pediatric patients were accrued to clinical trials at high levels, whereas after adolescence, only a small percentage of cancer patients were enrolled onto clinical trials. There were few differences by sex. Black males as well as Asian-American and Hispanic adults were accrued to clinical trials at lower rates than white cancer patients of the same age. Overall, the highest observed accrual was in suburban counties. Compared with the United States population, patients enrolled onto clinical trials were significantly less likely to be uninsured and more like to have Medicare health insurance. Geographic areas with higher socioeconomic levels had higher levels of clinical trial accruals. The number of oncologists and the presence of approved cancer programs both were significantly associated with increased accrual to clinical trials. CONCLUSION: We must work to increase the number of adults who enroll onto trials, especially among the elderly. Ongoing partnership with professional societies may be an effective approach to strengthen accrual to clinical trials.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7080-7080
Author(s):  
Emeline Aviki ◽  
Fumiko Chino ◽  
Julia Ramirez ◽  
Victoria Susana Blinder ◽  
Jennifer Jean Mueller ◽  
...  

7080 Background: Awareness of cancer patients’ financial toxicity (FT) has increased substantially over the past decade; however, interventions to minimize financial burden remain underdeveloped and understudied. This survey-based study explores patient beliefs on which potential mitigating strategies could improve their financial hardship during cancer treatment. Methods: Interviewer-administered surveys were conducted with consecutive patients in an outpatient, urban, private academic Gynecologic Cancer clinic waiting room for 2 weeks in August 2019. The survey items included patient demographics, disease characteristics, the Comprehensive Score for Financial Toxicity (COST) tool (validated measure of FT with score 0-44; lower scores indicate worse FT), assessment of cost-coping strategies, and patient-reported anticipated benefit from described potential interventions (items that were feasible and relevant to implement in clinic). Results: Of 101 patients who initiated the survey, 87 (86%) completed it and were included in this analysis. The median age was 66 (range, 32-87). Thirty-eight patients (44%) had ovarian, 29 (33%) uterine, 5 (6%) cervical, and 15 (17%) an “other” gynecologic cancer. The median COST score was 32 (range, 6-44). Twenty-nine patients (33%) had COST scores ≤25 and 16 (18%) had COST scores ≤18. The most frequent cost-coping strategy reported was reducing leisure activities (n = 36, 41%) and using savings to pay for medical bills (n = 34, 39%). Six patients (7%) reported not taking a prescribed medication in the past 12 months due to the inability to pay and 0 reported skipping a recommended imaging study. When it came to interventions patients anticipated would improve their current financial hardships, 34 (39%) indicated access to transportation assistance to and from appointments, 31 (36%) said “knowing up front how much I’m going to have to pay for my healthcare”, 29 (33%) indicated “minimizing wait time associated with appointments, which keeps me away from work”, and 22 (25%) indicated “access to free food during/around appointments and treatments”. Only 26 (30%) noted they were not experiencing financial hardship. Conclusions: For an outpatient population of gynecologic cancer patients, several focused, feasible interventions could be implemented to potentially decrease patient FT. Our study can help health care providers in the design of interventions to create meaningful improvements in patient financial burden. Next steps should assess the impact of targeted interventions on patient outcomes.


2021 ◽  
Author(s):  
◽  
Rūdolfs Cešeiko ◽  

Objective. Breast cancer (BC) is the most frequently diagnosed type of cancer among women, with more than 2 million new cases and over 600 000 deaths annually (Bray et al., 2018), and its global incidence is steadily rising. BC patients through the cancer continuum experience complex health and psychosocial challenges. BC and anti-cancer treatment accompanied by an inactive lifestyle may further impair muscle strength and muscle force development characteristics. Historically, patients diagnosed with cancer were advises to rest and avoid vigorous activity following their diagnosis, but this dogma has changed markedly over the last 20 years as exercise oncology intervention studies have gained broad acceptance and acknowledgment. Strength training can optimally affect muscles and increased muscle strength may contribute to participation in daily activities, thus potentially improving the health-related quality of life (HRQoL). However, the optimal type, intensity and frequency of strength training, as a part of cancer care, that will most enhance muscle strength during anti-cancer treatment is yet unknown. Christensen et al. (Christensen et al., 2014) investigated newly confirmed (breast, gastric, colorectal, lung and pancreas) cancer patients and concluded that these patients had 0.9 kg lower muscle mass compared with healthy controls even before the initiation of anti-cancer treatment. Furthermore, during adjuvant chemotherapy, BC patients lost 1.3 kg lean body mass (LBM), and continued to lose LBM after therapy was completed. Ultimately, BC survivors evaluated after completion of primary therapy displayed 20–30% lower muscle strength compared with healthy counterparts. Most physical activity interventions for BC patients combine aerobic endurance training with strength training and diverse relaxation therapies, hence making it more complicated to evaluate the impact of training type. There has been a limited number of well-defined clinical trials on BC patients that include higher intensity strength training, moreover when intervention is administered during adjuvant treatment. Training intensities vary substantially across cancer studies ranging from 25–80% of one-repetition maximum (1RM), although, it has been documented that higher training intensities yield greater strength gains in young healthy individuals (Campos et al., 2002). Similarly, greater gains in muscle strength are documented with increasing intensity for cancer patients, however, these patients are likely to have some improvement even at low training intensities (Fairman et al., 2017). The common consent from clinical trials when strength training interventions were applied for cancer patients states that training programs were well tolerated, they are safe, feasible and showed strength improvements that led to improved physical functioning and improved HRQoL (Segal et al., 2003), (De Backer et al., 2007), (Battaglini et al., 2014). Recognizing that training intensity during strength training is a key factor to improve maximal muscular strength and strength related characteristics. Therefore, well-defined training methods with high intensity could also be preferable to induce greater physiological adaptations, thus contribute to faster recovery from specific cancer treatment and enhancing the completion of prescribed anti-cancer treatment.


2021 ◽  
Author(s):  
◽  
Rūdolfs Cešeiko ◽  

Objective. Breast cancer (BC) is the most frequently diagnosed type of cancer among women, with more than 2 million new cases and over 600 000 deaths annually (Bray et al., 2018), and its global incidence is steadily rising. BC patients through the cancer continuum experience complex health and psychosocial challenges. BC and anti-cancer treatment accompanied by an inactive lifestyle may further impair muscle strength and muscle force development characteristics. Historically, patients diagnosed with cancer were advises to rest and avoid vigorous activity following their diagnosis, but this dogma has changed markedly over the last 20 years as exercise oncology intervention studies have gained broad acceptance and acknowledgment. Strength training can optimally affect muscles and increased muscle strength may contribute to participation in daily activities, thus potentially improving the health-related quality of life (HRQoL). However, the optimal type, intensity and frequency of strength training, as a part of cancer care, that will most enhance muscle strength during anti-cancer treatment is yet unknown. Christensen et al. (Christensen et al., 2014) investigated newly confirmed (breast, gastric, colorectal, lung and pancreas) cancer patients and concluded that these patients had 0.9 kg lower muscle mass compared with healthy controls even before the initiation of anti-cancer treatment. Furthermore, during adjuvant chemotherapy, BC patients lost 1.3 kg lean body mass (LBM), and continued to lose LBM after therapy was completed. Ultimately, BC survivors evaluated after completion of primary therapy displayed 20–30% lower muscle strength compared with healthy counterparts. Most physical activity interventions for BC patients combine aerobic endurance training with strength training and diverse relaxation therapies, hence making it more complicated to evaluate the impact of training type. There has been a limited number of well-defined clinical trials on BC patients that include higher intensity strength training, moreover when intervention is administered during adjuvant treatment. Training intensities vary substantially across cancer studies ranging from 25–80% of one-repetition maximum (1RM), although, it has been documented that higher training intensities yield greater strength gains in young healthy individuals (Campos et al., 2002). Similarly, greater gains in muscle strength are documented with increasing intensity for cancer patients, however, these patients are likely to have some improvement even at low training intensities (Fairman et al., 2017). The common consent from clinical trials when strength training interventions were applied for cancer patients states that training programs were well tolerated, they are safe, feasible and showed strength improvements that led to improved physical functioning and improved HRQoL (Segal et al., 2003), (De Backer et al., 2007), (Battaglini et al., 2014). Recognizing that training intensity during strength training is a key factor to improve maximal muscular strength and strength related characteristics. Therefore, well-defined training methods with high intensity could also be preferable to induce greater physiological adaptations, thus contribute to faster recovery from specific cancer treatment and enhancing the completion of prescribed anti-cancer treatment.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6513-6513
Author(s):  
Joseph M. Unger ◽  
Michael Leo LeBlanc ◽  
Charles David Blanke

6513 Background: Recently, tremendous prominence has been given to the investigation of the impact of different research processes as part of the Cancer Moonshot. More than half a century ago, the National Cancer Institute (NCI) established a network of publicly-funded cancer cooperative research groups to systematically advance the science of clinical trial research and the evaluation of new treatments for efficacy and safety. Our objective was to examine the extent to which positive NCI-sponsored cancer treatment trials have benefited cancer patients in the U.S. population. Methods: We used study data from SWOG, an NCI-sponsored Network cooperative research group. We identified all treatment trials over SWOG’s 60-year history (1956-2016) for which the new experimental therapy provided a statistically significant improvement in overall survival. We assumed the new, proven treatments from these trials established new standards for care in the treatment community. Twenty-three treatment trials were identified from a variety of difference cancer types. We estimated population life-years gained from the trials through 2015 by mapping the impact of the new treatments onto the U.S. cancer population, using an area-under-the-survival-curve approach that combined trial-specific hazard function and hazard ratio results with SEER and life-table data. Calculations were age-adjusted. Dollar return on investment was estimated as the ratio of total investment by the National Cancer Institute in the SWOG treatment trial program divided by the estimate of life-years gained. Results: In total, 12,361 patients were enrolled to the 23 positive trials from 1965-2012. We estimated that 3.34 million years of life were gained through 2015. Estimates were greater than 2 million life years gained under 95% of model simulations. The dollar return on investment was $125 per life year gained. Conclusions: SWOG treatment trials have had a substantial impact on population survival for cancer patients over 60 years. The National Cancer Institute’s investment in its cancer cooperative group research program has provided exceptional value and benefit to the American public.


2008 ◽  
Vol 26 (20) ◽  
pp. 3380-3386 ◽  
Author(s):  
Claudia R. Baquet ◽  
Gary L. Ellison ◽  
Shiraz I. Mishra

Purpose We examined the relationship of sociodemographic factors, urban/rural residence, and county-level socioeconomic factors on accrual of Maryland patients with cancer to National Cancer Institute (NCI) –sponsored cancer treatment clinical trials. Patients and Methods Data were analyzed for the period 1999 to 2002 for 2,240 Maryland patients with cancer accrued onto NCI-sponsored treatment trials. The extent to which Maryland patients with cancer and patients residing in lower socioeconomic and/or rural areas were accrued to cancer trials and were representative of all patients with cancer in Maryland was determined. Data were obtained from several sources, including NCI's Cancer Therapy Evaluation Program for Maryland patients with cancer in Cooperative Group therapeutic trials, Maryland Cancer Registry data on cancer incidence, and United States Census and the Department of Agriculture. Results For Maryland patients with cancer accrued onto NCI-sponsored treatment trials between 1999 and 2002, subgroups accrued at a higher rate included pediatric and adolescent age groups, white patients, female patients (for sex-specific tumors), patients with private health insurance, and patients residing in the Maryland National Capitol region. Moreover, between 1999 and 2002, there was an estimated annual decline (8.9% per year; P < .05) in the percentage of black patients accrued onto cancer treatment trials. Logistic regression models uncovered different patterns of accrual for female patients and male patients on county-level socioeconomic factors. Conclusion Results highlight disparities in the accrual of Maryland patients with cancer onto NCI-sponsored treatment trials based on patient age, race/ethnicity, geography of residence, and county-level socioeconomic factors. Findings provide the basis for development of innovative tailored and targeted educational efforts to improve trial accrual, particularly for the underserved.


2009 ◽  
Vol 27 (30) ◽  
pp. 5109-5114 ◽  
Author(s):  
Edward L. Trimble ◽  
Jeffrey S. Abrams ◽  
Ralph M. Meyer ◽  
Fabien Calvo ◽  
Eduardo Cazap ◽  
...  

Purpose The need for international collaboration in cancer clinical trials has grown stronger as we have made progress both in cancer treatment and screening. We sought to identify those efforts already underway which facilitate such collaboration, as well as barriers to greater collaboration. Methods We reviewed the collective experiences of many cooperative groups, governmental organizations, nongovernmental organizations, and academic investigators in their work to build international collaboration in cancer clinical trials across multiple disease sites. Results More than a decade of work has led to effective global harmonization for many of the elements critical to cancer clinical trials. Many barriers remain, but effective international collaboration in academic cancer treatment trials should become the norm, rather than the exception. Conclusion Our ability to strengthen international collaborations will result in maximization of our resources and patients, permitting us to change practice by establishing more effective therapeutic strategies. Regulatory, logistical, and financial hurdles, however, often hamper the conduct of joint trials. We must work together as a global community to overcome these barriers so that we may continue to improve cancer treatment for patients around the world.


2018 ◽  
Vol 6 (2) ◽  
pp. 263-272
Author(s):  
Kisha Coa ◽  
Joel B. Epstein ◽  
Kathy McManus ◽  
Bruce Moskowitz

To describe how cancer treatment influences the dietary behaviors and food preferences of older adult cancer patients and explore associations between these dietary changes and common cancer symptoms. A convenience sample of 800 cancer patients age 55 years and older undergoing cancer treatment completed a self-administered questionnaire which assessed patients’ dietary changes, food preferences and aversions since starting treatment, and health outcomes. Descriptive statistics were conducted to examine associations between dietary changes and age groups (categorized as 55-64 years old, 65-74 years old, and 75 years old and older), and multivariable logistic regression was used to assess associations between dietary changes and health outcomes The majority of participants experienced at least one cancer symptom, with fatigue and poor appetite being most commonly reported. About half of respondents reported no change in appetite or thirst, but those who did report a change were more likely to report a decrease in appetite rather than an increase, and more likely to report an increase in thirst rather than a decrease. Most of the patterns were consistent across age groups but the oldest age group (75+) was less likely to report eating less frequently, and less likely to report certain increased taste and smell sensitivities. Characterizing the nutritional needs of older adult cancer patients is the first step in being able to address these needs. Future research is needed to evaluate potential strategies to address nutritional concerns, and to better understand the unique needs of specific subgroups of older adult cancer patients at high risk of experiencing dietary changes (e.g., those with head and neck cancer).


2021 ◽  
Author(s):  
Ahmed M Badheeb ◽  
Mohamed A Badheeb ◽  
Hamdi A Alhakimi

Abstract Background: The aim of this paper is to compare the patterns and determinants of cancer mortality in Najran region before and after the COVID-19 epidemics. The association between cancer mortality and each of age, sex, site of cancer, stage, and the 30-days survival rate after the last dose of chemotherapy were assessed.Materials & Methods: Adult cancer patients who died of cancer in King Khalid Hospital in Najran Saudi Arabia, were included in this retrospective observational study. We compared mortality patterns in a period of 6 months in 2020 (March to August) with the corresponding period of 2019.Results: 50 dead adult cancer patients were included, 24 in 2019 and 26 in 2020. Among them, 21% vs 42% were younger than 65 years of age; 61% vs 62% were males, for the years 2019 & 2020 respectively. The top three killers in 2019 were colorectal, gastro-esophageal cancers, and hepatocellular carcinoma, while in 2020 were colorectal, hepatocellular carcinoma, and lymphomas. About 16.7% of patients died within 30 days of receiving anti-cancer treatment in 2019 in comparison with 7.7% in 2020. The difference in the 30-days mortality after receiving anti-cancer treatment was not statistically significant between 2019 and 2020 (p = 0.329).Conclusion: The Year 2020, the time of the COVID-19pandemic, was not associated with a significant increase in short-term mortality among patients with malignancy in Najran, Saudi Arabia. Our results generally reflect the crucial role of strict preventive national measures in saving lives and warrants further exploration.


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