scholarly journals Implementing a Geriatric Assessment in Cooperative Group Clinical Cancer Trials: CALGB 360401

2011 ◽  
Vol 29 (10) ◽  
pp. 1290-1296 ◽  
Author(s):  
Arti Hurria ◽  
Constance T. Cirrincione ◽  
Hyman B. Muss ◽  
Alice B. Kornblith ◽  
William Barry ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Geriatric Assessment ◽  
Health Care Professionals ◽  
Assessment Tool ◽  
Healthcare Providers ◽  
Psychological State ◽  
Cooperative Group ◽  
Group Setting ◽  
Assessment Measures ◽  
Cancer Trials

Purpose Factors captured in a geriatric assessment can predict morbidity and mortality in older adults, but are not routinely measured in cancer clinical trials. This study evaluated the implementation of a geriatric assessment tool in the cooperative group setting. Patients and Methods Patients age ≥ 65 with cancer, who enrolled on cooperative group cancer trials, were eligible to enroll on Cancer and Leukemia Group B (CALGB) 360401. They completed a geriatric assessment tool before initiation of protocol therapy, consisting of valid and reliable geriatric assessment measures which are primarily self-administered and require minimal resources and time by healthcare providers. The assessment measures functional status, comorbidity, cognitive function, psychological state, social support, and nutritional status. The protocol specified criteria for incorporation of the tool in future cooperative group trials was based on the time to completion and percent of patients who could complete their portion without assistance. Patient satisfaction with the tool was captured. Results Of the 93 patients who enrolled in this study, five (5%) met criteria for cognitive impairment and three did not complete the cognitive screen, leaving 85 assessable patients (median age, 72 years). The median time to complete the geriatric assessment tool was 22 minutes, 87% of patients (n = 74) completed their portion without assistance, 92% (n = 78) were satisfied with the questionnaire length, 95% (n = 81) reported no difficult questions, and 96% (n = 82) reported no upsetting questions. One hundred percent of health care professionals completed their portion. Conclusion This brief, primarily self-administered geriatric assessment tool met the protocol specified criteria for inclusion in future cooperative group clinical trials.

scholarly journals Barriers to conducting cancer trials in Canada: an analysis of key informant interviews

2020 ◽  
Vol 27 (3) ◽  
Author(s):  
C. Bentley ◽  
S. Sundquist ◽  
J. Dancey ◽  
S. Peacock
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Health Care Professionals ◽  
Leading Edge ◽  
Spillover Effects ◽  
Comparative Approach ◽  
Software Application ◽  
Canadian Health ◽  
Oncology Clinical Trials ◽  
Cancer Trials

Background In Canada, there is growing evidence that oncology clinical trials units (ctus) and programs face serious financial challenges. Investment in cancer research in Canada has declined almost 20% in the 5 years since its peak in 2011, and the costs of conducting leading-edge trials are rising. Clinical trials units must therefore be strategic about which studies they open. We interviewed Canadian health care professionals responsible for running cancer trials programs to identify the barriers to sustainability that they face. Methods One-on-one telephone interviews were conducted with clinicians and clinical research professionals at oncology ctus in Canada. We asked for their perspectives about the barriers to conducting trials at their institutions, in their provinces, and nationwide. Interviews were digitally recorded, transcribed, anonymized, and coded in the NVivo software application (version 11: QSR International, Melbourne, Australia). The initial coding structure was informed by the interview script, with new concepts drawn out and coded during analysis, using a constant comparative approach. Results Between June 2017 and November 2018, 25 interviews were conducted. Key barriers that participants identified were ■ insufficient stable funding to support trials infrastructure and retain staff; ■ the need to adopt strict cost-recovery policies, leading to fewer academic trials in portfolios; and ■ an overreliance on industry to fund clinical research in Canada. Conclusions Funding uncertainties have led ctus to increasingly rely on industry sponsorship and more stringent feasibility thresholds to remain solvent. Retaining skilled trials staff can create efficiencies in opening and running studies, with spillover effects of more trials being open to patients. More academic studies are needed to curb industry’s influence.  

Feasibility of a self-administered geriatric assessment tool for older patients with cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18519-18519
Author(s):  
A. Hurria ◽  
S. Lichtman ◽  
S. Priyadarshi ◽  
J. Gardes ◽  
E. Zuckerman ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Geriatric Assessment ◽  
Older Patients ◽  
Assessment Tool ◽  
Psychological State ◽  
Study Cohort ◽  
Healthcare Team ◽  
Mortality And Morbidity ◽  
Staff Members ◽  
Assessment Scores

18519 Background: As the population ages, there is an emerging need to develop a geriatric assessment (GA) tool for oncologists to characterize the ‘functional age‘ of older patients in order to tailor treatment, stratify outcomes by factors other than chronological age, and develop interventions to optimize cancer treatment. The GA tool must be easy to administer in order to minimize burden on clinic resources. The goal of this study was to determine the feasibility of administering a brief, comprehensive, self-administered GA tool to older patients before their meeting with the oncologist. Methods: The self-administered GA tool addresses the following domains: functional status, comorbidity, psychological state, nutritional status, and social support. The measures which comprise the tool are brief, reliable, validated, predictive of mortality and morbidity in older patients, and do not require a staff member to administer. Feasibility was assessed by the following parameters: 1) % able to complete the GA tool unassisted; 2) % requiring the assistance of staff members versus non-staff members; 3) overall patient satisfaction; 4) time to complete. Results: 168 (96%) of 175 patients completed the GA tool with a mean age of 76 (range 64–92) with AJCC stages [I (33%), II (17%), III (10%), IV (39%)] across a variety of tumor types. Of the study cohort, 67% were women, 57% were married, and 89% were retired. Median time to complete the GA tool was 13 minutes and mean time was 16 minutes (SD 11, range 3–60). Most completed the GA tool on their own (75%) or received assistance from a friend or family member (20%). Only 4% required assistance from a member of the healthcare team. Patient satisfaction with the GA tool was high: 88% satisfied with the length, 92% reported no difficult questions, and 97% reported no upsetting questions. Based on the assessment scores, the following interventions were offered: referral to a social worker (38%), nutritionist (43%), visiting nurse/home health aide (30%), internist (23%), rehabilitation (13%), ENT (13%), ophthalmology (7%), and psychiatry (5%). Conclusion: This brief, comprehensive, self-administered GA tool is feasible for use in the outpatient oncology setting. Prospective trials are needed to determine the effectiveness of the interventions offered. No significant financial relationships to disclose.

scholarly journals US Cancer Centers of Excellence Strategies for Increased Inclusion of Racial and Ethnic Minorities in Clinical Trials

2019 ◽  
Vol 15 (4) ◽  
pp. e289-e299 ◽  
Author(s):  
Jeanne M. Regnante ◽  
Nicole A. Richie ◽  
Lola Fashoyin-Aje ◽  
Michelle Vichnin ◽  
Marvella Ford ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Health Care Professionals ◽  
Working Group ◽  
Minority Groups ◽  
Community Outreach ◽  
Cancer Center ◽  
National Minority ◽  
Centers Of Excellence ◽  
Cancer Centers ◽  
Cancer Trials

PURPOSE: Participation of racial and ethnic minority groups (REMGs) in cancer trials is disproportionately low despite a high prevalence of certain cancers in REMG populations. We aimed to identify notable practices used by leading US cancer centers that facilitate REMG participation in cancer trials. METHODS: The National Minority Quality Forum and Sustainable Healthy Communities Diverse Cancer Communities Working Group developed criteria by which to identify eligible US cancer centers—REMGs comprise 10% or more of the catchment area; a 10% to 50% yearly accrual rate of REMGs in cancer trials; and the presence of formal community outreach and diversity enrollment programs. Cancer center leaders were interviewed to ascertain notable practices that facilitate REMG accrual in clinical trials. RESULTS: Eight cancer centers that met the Communities Working Group criteria were invited to participate in in-depth interviews. Notable strategies for increased REMG accrual to cancer trials were reported across five broad themes: commitment and center leadership, investigator training and mentoring, community engagement, patient engagement, and operational practices. Specific notable practices included increased engagement of health care professionals, the presence of formal processes for obtaining REMG patient/caregiver input on research projects, and engagement of community groups to drive REMG participation. Centers also reported an increase in the allocation of resources to improving health disparities and increased dedication of research staff to REMG engagement. CONCLUSION: We have identified notable practices that facilitate increased participation of REMGs in cancer trials. Wide implementation of such strategies across cancer centers is essential to ensure that all populations benefit from advances in an era of increasingly personalized treatment of cancer.

scholarly journals Development of Clinical Trials in a Cooperative Group Setting: The Eastern Cooperative Oncology Group

2008 ◽  
Vol 14 (11) ◽  
pp. 3427-3433 ◽  
Author(s):  
David M. Dilts ◽  
Alan Sandler ◽  
Steven Cheng ◽  
Joshua Crites ◽  
Lori Ferranti ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Eastern Cooperative Oncology Group ◽  
Cooperative Group ◽  
Oncology Group ◽  
Group Setting

Clinical trials — the personal perspective of the research physician?

2020 ◽  
Vol 75 (3) ◽  
pp. 256-263
Author(s):  
Maria Y. Egorova ◽  
Irina A. Shuvalova ◽  
Olga I. Zvonareva ◽  
Igor D. Pimenov ◽  
Olga S. Kobyakova ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Care ◽  
New Technologies ◽  
Healthcare Providers ◽  
Study Drug ◽  
Well Being ◽  
Personal Perspective ◽  
Public And Private ◽  
Factors Affecting ◽  
To Receive

Background. The organization of clinical trials (CTs) requires the participation and coordination of healthcare providers, patients, public and private parties. Obstacles to the participation of any of these groups pose a risk of lowering the potential for the implementation of CTs. Researchers are a key human resource in conducting of CT. Their motivation for participation can have a significant impact on the recruitment and retention of patients, on the quality of the data collected, which determines the overall outcome of the study. Aims to assess the factors affecting the inclusion of Russian physicians-researchers in CT, and to determine their role in relations with patients-participants. Materials and methods. The study was organized as a part of the Russian multicenter face-to-face study. A survey was conducted of researchers from 10 cities of Russia (20172018). The participation in the survey for doctors was anonymous and voluntary. Results. The study involved 78 respondents. Most research doctors highly value the importance of research for science (4,84 0,39), society (4,67 0,46) and slightly lower for participating patients (4,44 0,61). The expectations of medical researchers are related to improving their financial situation and attaining new experience (n = 14; 18,18%). However, the opportunity to work with new technologies of treatment and diagnosis (n = 41; 52,56%) acted as a motivating factor. According to the questionnaire, the vast majority of research doctors (n = 29; 37,18%) believe that the main reason for patients to participate in CT is to receive quality and free medical care. The most significant obstacle to the inclusion of participants in CT was the side effects of the study drug (n = 38; 48,71%). Conclusions. The potential of clinical researchers in Russia is very high. The patient-participant acts for the research doctor as the subject of the study, and not the object, so the well-being of the patient is not indifferent to the doctor. However, the features of the functioning of our health care system form the motivation of doctors-researchers (additional earnings, professional self-development) and the way they perceive the motivation of patients (CT as an opportunity to receive quality medical care).

scholarly journals Exploring the experiences related to postpartum changes: perspectives of mothers and healthcare providers in Iran

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mahboobeh Asadi ◽  
Mahnaz Noroozi ◽  
Mousa Alavi
Keyword(s):  
Postpartum Period ◽  
Qualitative Content Analysis ◽  
Healthcare Providers ◽  
Educational Interventions ◽  
Psychological State ◽  
Structured Interviews ◽  
Childbearing Age ◽  
New Period ◽  
Women's Lives ◽  
Field Notes

Abstract Background Numerous changes occur in different aspects of women’s lives in the postpartum period. Women’s adjusting with problems and taking advantage of this opportunity can develop their personality. In this regard, accurate knowledge of their experiences and feelings is necessary to help them to benefit from this period. Therefore, the present study aimed to explore the experiences related to postpartum changes in women. Methods In the present qualitative study, 23 participants, including women of childbearing age who gave birth and healthcare providers (midwives and obstetricians) in Isfahan, Iran were selected using purposive sampling with a maximum variation strategy. Data were collected through in-depth semi structured interviews, field notes, and daily notes, and simultaneously analyzed using the conventional qualitative content analysis. Results The data analysis results led to the extraction of three main categories including “feeling of decreased female attractiveness” (with two sub-categories of “ feeling of decreased beauty” and “feeling of decreased sexual function”), “feeling of insolvency and helplessness” (with two sub-categories of “physical burnout”, and “mental preoccupations”) and “beginning a new period in life” (with three sub-categories of “changing the meaning of life”, “feeling of maturity” and “deepening the communication”). Conclusions Findings of this study can provide a good context for designing interventions to improve the women’s quality of life by explaining and highlighting their experiences in the postpartum period. In this regard, providing sufficient empathy, social and psychological support from family members (especially husband), performing appropriate educational interventions and also regular assessment of women’s psychological state by healthcare providers in postpartum period can reduce their concerns and help to improve their health.

scholarly journals A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach

2020 ◽  
Vol 4 (1) ◽  
pp. 13-27 ◽  
Author(s):  
Lynn Rochester ◽  
Claudia Mazzà ◽  
Arne Mueller ◽  
Brian Caulfield ◽  
Marie McCarthy ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Health Care Professionals ◽  
Digital Health ◽  
Disease Status ◽  
Proximal Femoral Fracture ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Physical Mobility ◽  
High Level

Health care has had to adapt rapidly to COVID-19, and this in turn has highlighted a pressing need for tools to facilitate remote visits and monitoring. Digital health technology, including body-worn devices, offers a solution using digital outcomes to measure and monitor disease status and provide outcomes meaningful to both patients and health care professionals. Remote monitoring of physical mobility is a prime example, because mobility is among the most advanced modalities that can be assessed digitally and remotely. Loss of mobility is also an important feature of many health conditions, providing a read-out of health as well as a target for intervention. Real-world, continuous digital measures of mobility (digital mobility outcomes or DMOs) provide an opportunity for novel insights into health care conditions complementing existing mobility measures. Accepted and approved DMOs are not yet widely available. The need for large collaborative efforts to tackle the critical steps to adoption is widely recognised. Mobilise-D is an example. It is a multidisciplinary consortium of 34 institutions from academia and industry funded through the European Innovative Medicines Initiative 2 Joint Undertaking. Members of Mobilise-D are collaborating to address the critical steps for DMOs to be adopted in clinical trials and ultimately health care. To achieve this, the consortium has developed a roadmap to inform the development, validation and approval of DMOs in Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease and recovery from proximal femoral fracture. Here we aim to describe the proposed approach and provide a high-level view of the ongoing and planned work of the Mobilise-D consortium. Ultimately, Mobilise-D aims to stimulate widespread adoption of DMOs through the provision of device agnostic software, standards and robust validation in order to bring digital outcomes from concept to use in clinical trials and health care.

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