Identification of barriers to clinical trials: The impact of education level.

Eads, Jennifer R.; Albrecht, Terrance L.; Egleston, Brian L.; Buzaglo, Joanne S.; Cohen, Robert B.; Fleisher, Linda; Foster, Tanina; Katz, Michael; Kinzy, Tyler G.; Manne, Sharon L.; Miller, Dawn M.; Miller, Scott; Raivitch, Stephanie; Roach, Nancy; Silver, Alexis

doi:10.1200/jco.2011.29.15_suppl.6003

Cited by 8 publications

(31 citation statements)

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“…Findings from a previously conducted pilot study with 156 patients receiving care at one of two NCI-designated comprehensive cancer centers [47] guided our development process. These patients completed a survey that contained eight background and demographic questions, 19 knowledge-based items, and 29 attitudinal barrier questions.…”

Section: Methodsmentioning

confidence: 99%

“…Although the focus of most research on patient barriers has been on practical barriers (e.g. financial concerns and lack of access) [3,5,7], we [8,13,14,47] and others [6,7,9–12,15–22] have found that that there are also key psychosocial barriers that limit patient participation. These include lack of knowledge and concerns about side effects and randomization, fear of placebos, and feeling “like a guinea pig.” These barriers negatively impact patient preparedness to consider clinical trials as an option [28] and are difficult to adequately address during the physician consultation, potentially leading to suboptimal treatment decisions.…”

Section: Introductionmentioning

confidence: 99%

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Application of best practice approaches for designing decision support tools: The preparatory education about clinical trials (PRE-ACT) study

Fleisher¹,

Ruggieri²,

Miller³

et al. 2014

Patient Education and Counseling

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Objective This article describes the rigorous development process and initial feedback of the PRE-ACT (Preparatory Education About Clinical Trials) web-based- intervention designed to improve preparation for decision making in cancer clinical trials. Methods The multi-step process included stakeholder input, formative research, user testing and feedback. Diverse teams (researchers, advocates and developers) participated including content refinement, identification of actors, and development of video scripts. Patient feedback was provided in the final production period and through a vanguard group (N = 100) from the randomized trial. Results Patients/advocates confirmed barriers to cancer clinical trial participation, including lack of awareness and knowledge, fear of side effects, logistical concerns, and mistrust. Patients indicated they liked the tool’s user-friendly nature, the organized and comprehensive presentation of the subject matter, and the clarity of the videos. Conclusion The development process serves as an example of operationalizing best practice approaches and highlights the value of a multi-disciplinary team to develop a theory-based, sophisticated tool that patients found useful in their decision making process. Practice implications Best practice approaches can be addressed and are important to ensure evidence-based tools that are of value to patients and supports the usefulness of a process map in the development of e-health tools.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Application of best practice approaches for designing decision support tools: The preparatory education about clinical trials (PRE-ACT) study

Fleisher¹,

Ruggieri²,

Miller³

et al. 2014

Patient Education and Counseling

View full text Add to dashboard Cite

show abstract

“…The barriers assessments were based on literature review, our prior work, focus groups, and pilot testing. 6,7,33,42,43 The preparation measure was adapted from the Ottawa Decision Support Framework. 44,45 The postintervention survey assessed satisfaction with the intervention (12 items) and reassessed knowledge, attitudinal barriers, and preparation.…”

Section: Methodsmentioning

confidence: 99%

“…These include knowledge gaps and attitudes that influence a patient's willingness or ability to consider a clinical trial as a therapeutic option. 6,7 Other influences on patient decision making about clinical trials derive from family members, communities, institutions, 16 and health-care providers. 10,17 Numerous studies have also characterized populations that are underrepresented in clinical trials, such as racial and ethnic minorities, [18][19][20][21][22] older patients, 4,23 and those of lower socioeconomic status, 24 supporting the development of tailored approaches to overcome barriers to participation.…”

Section: Introductionmentioning

confidence: 99%

“…[1][2][3] Barriers to clinical trial participation are multifactorial, and include practical impediments that limit access, as well as knowledge gaps and negative attitudes among both patients and their providers. [4][5][6][7][8][9][10][11] Although public awareness of clinical trials is improving, 12 there is little indication that patient participation has increased over several decades, suggesting that other fundamental barriers exist.…”

Section: Introductionmentioning

confidence: 99%

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Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials

Meropol

Wong

Albrecht

et al. 2016

JCO

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Purpose Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. Patients and Methods A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient’s barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. Results Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. Conclusion These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving knowledge and reducing attitudinal barriers.

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Comparing attitudes of younger and older patients towards cancer clinical trials

Ayodele

Akhtar

Konenko

et al. 2016

Journal of Geriatric Oncology

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Identification of barriers to clinical trials: The impact of education level.

Cited by 8 publications

References 0 publications

Application of best practice approaches for designing decision support tools: The preparatory education about clinical trials (PRE-ACT) study

Application of best practice approaches for designing decision support tools: The preparatory education about clinical trials (PRE-ACT) study

Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials

Comparing attitudes of younger and older patients towards cancer clinical trials

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