Participation of elderly gynecological cancer patients in clinical trials.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21520-e21520
Author(s):  
Katharina Prieske ◽  
Fabian Trillsch ◽  
Gulten Oskay-Oezcelik ◽  
Radoslav Chekerov ◽  
Eva-Maria Schoening ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Gynecological Cancer ◽  
Educational Background ◽  
General Information ◽  
Willingness To Participate ◽  
Study Participation ◽  
Long Distance ◽  
Cross Sectional ◽  
Potential Study

e21520 Background: Elderly patients (pts) are underrepresented in clinical trials in gynecological cancer, even though they are disproportionally often affected. This study aimed to evaluate disposition and apprehension of elderly pts towards study participation. Methods: 112 elderly gynecological cancer pts (median age 70; range 65-92) were surveyed in a multicenter cross-sectional study. Besides fitness, state of disease, education and domestic situation, questions aimed at the general willingness to participate in a clinical trial. Personal reasons for rejection and suspected advantages/disadvantages that might evolve from participation were inquired. Results: Willingness to participate in a study was generally high (66.1%, 74/112). 42/112 (37.5%) had given their consent to participation in a study before, 12.5% (6/48) refused even though they were offered participation. Reasons for potential study participation were: ‘better monitoring of the disease’ (51/112), ‘better medical care’ (35/112), ‘to help medical research’ (31/112), ‘better medication’ (27/112) and ‘because of my doctor’s recommendation’ (17/112). Reasons for potential refusal were: ‘too time consuming’ (19/112), ‘fear of side effects’ (17/112), ‘misuse as experimental animal’ (14/112), ‘long distance to clinic’ (11/112) and ‘too little or unclear information’ (7/112). 26.1% (29/112) of pts stated, that they had ‘no objection’ against study participation. The question if pts anticipated having a longer life due to study participation was answered with ‘yes’ or ‘rather yes’ in 33.9% (38/112), 23.2% answered ‘no’ or ‘rather no’ (23.2% undecided). No relation between willingness to participate in a study and general fitness (p = 0.311), education (p = 0.631) or domestic situation (p = 0.195) could be observed. However, with increasing age, willingness decreased (p = 0.029). Conclusions: Elderly pts are generally willing to participate in clinical studies regardless of their fitness or educational background. Benefits of participation seem to be unclear among a majority of potential study participants. Therefore it might be decisive to provide more general information regarding benefits and safety for the elderly pts in a clinical trial.

scholarly journals Translation and Validation of the Greek Version of a Questionnaire Measuring Patient Views on Participation in Clinical Trials

2021 ◽  
Author(s):  
Dimitrios Karampatakis ◽  
Angeliki Kakavouti-Doudos ◽  
Panagiotis Oikonomidis ◽  
Polychronis Voultsos
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cross Sectional Study ◽  
Willingness To Participate ◽  
Validity And Reliability ◽  
Greek Version ◽  
Factor Solution ◽  
Cross Sectional ◽  
Risks And Benefits ◽  
Patient Views

Abstract BackgroundThe increasing number of clinical research opportunities requires increasing numbers of participants in clinical trials. However, it may become increasingly problematic, as protocols have become increasingly complex. Better understanding of patients’ attitudes towards their potential participation in clinical trials is essential for developing effective clinical trial recruitment strategies. In Greece, limited research has been conducted on this topic so far. This study aims to contribute to filling this gap. MethodsA cross-sectional study was conducted. Purposive sampling was used to select participants. The Greek version of a recently developed questionnaire measuring patient views on participation in clinical trials, a 27‐item scale distributed into four factors, was tested. In addition, participants were asked to provide information regarding their socio-demographics. A demographic comparison was conducted.ResultsThe four-factor solution derived in our study consisted of the same 27 items and it was different from the six-factor solution that Arnetz et al. proposed. The factors risks and benefits, that consisted of 5 and 3 items respectively in the six-factor solution, were merged into one factor that consisted of 10 items in the four-factor solution. The four factors produced were Risks and benefits (ten items, α= 0,867), Patient’s expectations (six items, α= 0.864), Patient’s participation (five items, α= 0.827), and Cost and convenience (five items, α= 0,770). We found that demographic factors did not impact patients' opinions about clinical trials participation, except for gender. The participants reported as important for participating in clinical trial: receiving clear and adequate information (95,5%) and being given the opportunity to ask questions (97,8%), take part in discussions regarding their own treatment (94,6%), and voice their concerns and opinions (91,1%). As factors strongly associated with participants’ willingness to participate in a clinical trial were reported: concerns about the risks of being in a clinical trial (87,5%), the possible side effects of clinical trials (86,3%), the type of treatment given in a clinical trial (83,7%), and whether participation would improve their quality of life (QoL) (81,5%).ConclusionThe preliminary validation of the Greek version of the questionnaire measuring patient perceptions and expectations of participating in clinical trials demonstrated acceptable validity and reliability and could be further tested in larger samples. The findings that emerged from this study are in line with previous literature.

scholarly journals Translation and validation of the greek version of a questionnaire measuring patient views on participation in clinical trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Dimitrios Karampatakis ◽  
Angeliki Kakavouti-Doudos ◽  
Panagiotis Oikonomidis ◽  
Polychronis Voultsos
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cross Sectional Study ◽  
Willingness To Participate ◽  
Validity And Reliability ◽  
Greek Version ◽  
Factor Solution ◽  
Cross Sectional ◽  
Risks And Benefits ◽  
Patient Views

Abstract Background The increasing number of clinical research opportunities requires increasing numbers of participants in clinical trials. However, it may become increasingly problematic, as protocols have become increasingly complex. Better understanding of patients’ attitudes towards their potential participation in clinical trials is essential for developing effective clinical trial recruitment strategies. In Greece, limited research has been conducted on this topic so far. This study aims to contribute to filling this gap. Methods A cross-sectional study was conducted. Purposive sampling was used to select participants. The Greek version of a recently developed questionnaire measuring patient views on participation in clinical trials, a 27-item scale distributed into four factors, was tested. In addition, participants were asked to provide information regarding their socio-demographics. A demographic comparison was conducted. Results The four-factor solution derived in our study consisted of the same 27 items and it was different from the six-factor solution that Arnetz et al. proposed. The factors risks and benefits, that consisted of 5 and 3 items respectively in the six-factor solution, were merged into one factor that consisted of 10 items in the four-factor solution. The four factors produced were Risks and benefits (ten items, α = 0,867), Patient’s expectations (six items, α = 0.864), Patient’s participation (five items, α = 0.827), and Cost and convenience (five items, α = 0,770). We found that demographic factors did not impact patients’ opinions about clinical trials participation, except for gender. The participants reported as important for participating in clinical trial: receiving clear and adequate information (95,5 %) and being given the opportunity to ask questions (97,8 %), take part in discussions regarding their own treatment (94,6 %), and voice their concerns and opinions (91,1 %). As factors strongly associated with participants’ willingness to participate in a clinical trial were reported: concerns about the risks of being in a clinical trial (87,5 %), the possible side effects of clinical trials (86,3 %), the type of treatment given in a clinical trial (83,7 %), and whether participation would improve their quality of life (QoL) (81,5 %). Conclusions The preliminary validation of the Greek version of the questionnaire measuring patient perceptions and expectations of participating in clinical trials demonstrated acceptable validity and reliability and could be further tested in larger samples. The findings that emerged from this study are in line with previous literature.

scholarly journals Willingness to Participate in Vaccine-Related Clinical Trials among Older Adults

2018 ◽  
Vol 15 (8) ◽  
pp. 1743 ◽  
Author(s):  
Divyanshu Raheja ◽  
Evelyn Davila ◽  
Eric Johnson ◽  
Rijalda Deović ◽  
Michele Paine ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trials ◽  
Clinical Research ◽  
Elderly Person ◽  
The Elderly ◽  
Cross Sectional Study ◽  
Willingness To Participate ◽  
Cross Sectional ◽  
Convenience Sample ◽  
Research Findings

The purpose of this study is to understand among a convenience sample of 400 adults aged 60 years of age or older (1) reasons for being willing or unwilling to participate in a vaccine clinical research study and (2) overall perceptions about vaccine clinical research. A cross-sectional study using a sample of older adults residing in the metro-Atlanta area and surrounding neighborhoods was conducted. The study questionnaire contained 37 questions, including questions about socio-demographics and perceptions about clinical trial processes. Statistical analysis was conducted using logistic regression. The adjusted modeling results indicated that sex, distance to research clinic, and being informed about the research findings played a role in the likelihood of an elderly person participating in a vaccine study. Males were more likely to participate in clinical trials as compared to females (OR: 2.486; CI: 1.042–5.934). Most participants were willing to travel up to 25 miles from the research clinic. Of the respondents, 45% were unlikely to participate if the results of the current trial are not shared. Improving access to clinical trials in terms of distance traveled and ensuring streamlined processes to inform participants about the results of the trial in the future would increase willingness to participate in vaccine clinical trials. The survey could serve as a useful tool for conducting vaccine studies and other clinical trials by understanding the barriers specific to the elderly.

scholarly journals Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053096
Author(s):  
Maia Salholz-Hillel ◽  
Peter Grabitz ◽  
Molly Pugh-Jones ◽  
Daniel Strech ◽  
Nicholas J DeVito
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Journal Article ◽  
Cross Sectional Study ◽  
Sensitivity Analyses ◽  
Cross Sectional ◽  
Registration Data ◽  
Clinical Trial Registries ◽  
Treatment And Prevention

ObjectiveTo examine how and when the results of COVID-19 clinical trials are disseminated.DesignCross-sectional study.SettingThe COVID-19 clinical trial landscape.Participants285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020.Main outcome measuresOverall reporting and reporting by dissemination route (ie, by journal article, preprint or results on a registry); time to reporting by dissemination route.ResultsFollowing automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n=25) followed by journal articles (n=18), and results on a registry (n=2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%.ConclusionCOVID-19 trials completed during the first 6 months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared with non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data are accurate should be a priority for the research community during a pandemic. Data collection is underway for the next phase of the DIssemination of REgistered COVID-19 Clinical Trials study expanding both our trial population and follow-up time.

scholarly journals Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study

10.2196/14744 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e14744
Author(s):  
Vishal Vennu ◽  
Saurabh Dahiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Drugs ◽  
Survey Study ◽  
Multiple Sources ◽  
Cross Sectional ◽  
Web Based ◽  
Google Docs ◽  
New Drug ◽  
Research Professionals

Background Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. Objective This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. Methods In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. Results The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. Conclusions The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country. International Registered Report Identifier (IRRID) PRR1-10.2196/14744

The brain metastasis journey: Experience from patient, caregiver, and physician surveys on diagnosis and treatment of brain metastases.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e14004-e14004
Author(s):  
Albert Eusik Kim ◽  
GI-Ming WANG ◽  
Kristin A Waite ◽  
Scott Elder ◽  
Avery Fine ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Brain Metastases ◽  
Checkpoint Inhibitors ◽  
Treatment Options ◽  
Whole Brain Radiotherapy ◽  
Well Being ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Brain Radiotherapy

e14004 Background: Brain metastases (BM) is one of the most feared complications of cancer due to substantial neurologic sequalae, neuro-cognitive morbidity and grim prognosis. In the past decade, targeted therapies and checkpoint inhibitors have resulted in meaningfully improved overall survival for a minority of these patients. Accordingly, there is a growing need to identify issues surrounding patient survivorship and to standardize physician practice patterns for these patients. To date, there has not been a well-conducted formal study to specifically explore these questions of survivorship and practice standardization for BM patients. Methods: Here, we present results from a cross-sectional survey in which we analyzed responses from 237 BM patients, 209 caregivers, and 239 physicians. Surveys contained questions about BM symptoms, discussion of BM diagnosis by the clinician, psychosocial concerns, available treatment options for BM, BM patient advocacy resources, and BM-specific clinical trials. Results: Our survey revealed compelling findings about current care of BM patients. There were discrepancies in the perceived discussion of the implications of the diagnosis of BM, from the patient/caregiver and physician perspective. Important topics, such as prognosis and worrisome symptoms, were felt to have been discussed more frequently by physicians than by patients or caregivers. In our physician survey, private practice physicians, compared to academic physicians, were significantly more likely to recommend whole brain radiotherapy (61.1 vs 39.7%; p = 0.009). Participation in a clinical trial was one of the least recommended treatment options. Many physicians (59.1% private; 71.9% academic) stated that BM patients in their care are denied participation in a clinical trial, specifically due to the presence of BM. The consensus among physicians, patients and caregivers was that the highest yield area for federal assistance is increased treatment and research funding for BM. Conclusions: Our hope is that these findings will serve as a basis for future quality improvement measures to enhance patient-physician communication and patient well-being, continuing medical education activities detailing latest advances in BM for oncologists, and lobbying efforts to the federal government in prioritizing BM research, clinical trials, and patient survivorship.

Reconsenting patients with cancer on clinical trials: Does added risk influence continued participation?

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15610-e15610
Author(s):  
A. Elegbede ◽  
A. Andrei ◽  
A. Andrei ◽  
K. D. Holen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Event ◽  
Side Effects ◽  
Adverse Events ◽  
Study Participant ◽  
P Value ◽  
Study Participation ◽  
Grade 5 ◽  
Study Results

e15610 Background: The general policy endorsed by multiple professional societies and cooperative groups regarding patients on cancer clinical trials states that subjects should be informed of new adverse events or significant developments during study participation and re-consented to continue on study. However, no information is known as to the effect of re-consenting on a patients’ decision to continue study participation. Our research question addresses how the severity of reported risk to other study participants will impact the subjects’ decision to continue participation in a clinical trial. Methods: We surveyed 34 patients with gastrointestinal (GI) tumors all of whom were currently enrolled in a clinical trial. The survey portrayed hypothetical adverse reactions affecting another study participant ranging from Grade 1 to Grade 5 according to the National Cancer Institutes Common Terminology Criteria for Adverse Effects v. 3.0. The survey asked about subjects’ opinions of the theoretical adverse event categorized as “would not be concerned,” “would be concerned, but would continue the study,” and “would discontinue the study.” Results: Patients willingness to continue the study was highest at Grade 1 with 97% of all participants. However, willingness to continue participation progressively declined as the severity of adverse events increased such that only 44% of participants would continue participation with a reported Grade 5 adverse event. Conclusions: Among surveyed GI cancer patients, willingness to continue participation in a clinical trial declined significantly as the severity of adverse events increased from Grade 1 to Grade 3 - 5 (p-value < 0.001. This could be due to multiple factors, including the terminal nature of the patients’ cancer, the side effects of study therapy and the patients’ response to study treatment. This data could produce a reasonable adverse event grade cut-off for re-consenting patients regarding new side effects. No significant financial relationships to disclose.

scholarly journals OVERUSE INJURIES IN LONG DISTANCE RUNNING - A LITERATURE REVIEW ON RISK FACTORS

2019 ◽  
pp. 1-3
Author(s):  
G Vijayan
Keyword(s):  
Risk Factors ◽  
Clinical Trials ◽  
Overuse Injuries ◽  
Distance Running ◽  
Long Distance ◽  
Cross Sectional ◽  
Recreational Athletes ◽  
Long Distance Running ◽  
History Of ◽  
Cross Sectional Studies

INTRODUCTION: In the past three decades, the incidence of running-related overuse injuries has signicantly increased because of the increasing number of recreational athletes and higher training intensity in competitive athletes. Long distance running has gained popularity in recent years, but between 19.4 and 79.3% of runners sustain a running related injury every year. Various risk factors contribute to the occurrence of this issue and shoe modications are thought to be an efcient tool in managing runningrelated over use injuries. The aim of this study was to collect and review information about the risks factors of overuse injuries long distance running. METHODOLOGY:Asystematic search of the electronic database of PUBMED, Bireme and PEDro which were selected that addressed clinical trials, control cases, prospective and cross-sectional studies. RESULTS: The search yielded 246 references. A predened inclusion criteria (case studies, clinical trials, prospective studies, cross sectional studies that addressed adult runners either amateur or professional) was used and 51 articles remained. 18 citations were excluded and 20 articles were after reading the abstract and full text. Therefore 13 studies that met the criteria for analysis were included. CONCLUSION:The overuse injuries are very much prevalent in long distance runners and the ethology is multifactorial. The distance, terrain, weekly sessions and history of previous injuries are the risk factors that inuence the occurrence of these injuries.

scholarly journals Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study (Preprint)

2019 ◽  
Author(s):  
Vishal Vennu ◽  
Saurabh Dahiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Drugs ◽  
Survey Study ◽  
Multiple Sources ◽  
Cross Sectional ◽  
Web Based ◽  
Google Docs ◽  
New Drug ◽  
Research Professionals

BACKGROUND Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. OBJECTIVE This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. METHODS In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. RESULTS The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. CONCLUSIONS The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/14744

Sign in / Sign up

Export Citation Format

Share Document