Participant Enrollment, Participation, and Compliance in Chemoprevention Trials

Rimer, Barbara K.

doi:10.1007/978-1-4615-3468-6_15

Cited by 13 publications

(9 citation statements)

References 24 publications

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“…The relationship between the physician and patient or the patient and the "study team" is critically important in maintaining participant adherence to both the intervention and the protocol (31). The long duration of most chemo-prevention trials requires that the investigator, study coordinator, or some member of the study team make frequent contact with participants to provide positive reinforcement and feedback (30,3 1).…”

Section: Compliance/adherence Issuesmentioning

confidence: 99%

“…First, one must carefully screen potential participants before enrolling them in a trial. Individuals should be provided with full information on the specifics of the trial regimen and the importance of their full and complete cooperation (31,32). In this regard, many trials have used patientfriendly brochure^'^ or pamphlets, written in laymen's terms, which explain not only the trial objectives but also the methods specific to the conduct of a clinical trial, such as the informed consent process and randomization procedures (30,33).…”

Section: Compliance/adherence Issuesmentioning

confidence: 99%

“…If patients fail to take a majority (>80%) of their "medication" or fail to report to follow-up visits, they are not randomized. Screening out poorly motivated patients is crucial to both long-term retention and the trial's ability to detect differences between the intervention and control groups (31).…”

Section: Compliance/adherence Issuesmentioning

confidence: 99%

“…Strategies are available that can improve the likelihood of maintaining optimal participant compliance (28, [30][31][32]. First, one must carefully screen potential participants before enrolling them in a trial.…”

Section: Compliance/adherence Issuesmentioning

confidence: 99%

See 3 more Smart Citations

Patient Participation and Compliance in Cancer Chemoprevention Trials: Issues and Concerns

Tangrea¹

1997

Experimental Biology and Medicine

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Cancer chemoprevention trials have unique characteristics that make the tasks of participant recruitment, enrollment, and long-term adherence to the study protocol and intervention regimen especially difficult. Barriers to patient accrual, long-term participation, and optimal adherence are inherent in clinical trial design and organization, and are frequently associated with the attitudes and behavioral dynamics of physicians and the participants themselves. Attracting racially and ethnically diverse populations to trial participation adds additional problems and considerations. Careful planning early in the design phase of a chemoprevention clinical trial must take into account these numerous issues. Clinical investigators should seek expert advice from a number of health care disciplines to better design chemoprevention protocols that minimize logistic complexity, maximize participant eligibility, simplify data collection, and take into account the complex behavioral dynamics of the clinical trial process.

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Section: Compliance/adherence Issuesmentioning

confidence: 99%

Section: Compliance/adherence Issuesmentioning

confidence: 99%

Section: Compliance/adherence Issuesmentioning

confidence: 99%

Section: Compliance/adherence Issuesmentioning

confidence: 99%

See 2 more Smart Citations

Patient Participation and Compliance in Cancer Chemoprevention Trials: Issues and Concerns

Tangrea¹

1997

Experimental Biology and Medicine

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“…Individuals who volunteer to participate in research studies frequently differ significantly from those who do not participate 1–5 . Dissimilarities between studied populations and those whom the study's conclusions are presumed to represent may lead to concerns about the generalisability and/or validity of study results 2,3,6,7 .…”

Section: Introductionmentioning

confidence: 99%

Assessing participation bias in a population‐based study of measles‐mumps‐rubella vaccine immunity in children and adolescents aged 12–18

Sauver¹,

Jacobsen²,

Jacobson

et al. 2007

Paediatric Perinatal Epid

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The purpose of our study was to determine whether specific characteristics were associated with study participation in a group of children residing in Olmsted County, MN. We compared 346 participants and 848 non-participants from a study examining associations between human leukocyte antigen gene variants and immunity following measles-mumps-rubella (MMR) vaccination by demographic characteristics, MMR vaccination history and length of time in the Olmsted County health care system. We also compared the frequency and reasons for health care visits between participants and non-participants by comparing diagnostic codes for all visits that had occurred between 1999 and 2001. Characteristics were compared using chi-square and t-tests, followed by multivariable logistic regression. Study participants were more likely to be white/Caucasian, to have received their first MMR vaccination at a younger age, and to have had more health care visits (especially for acute respiratory illnesses, vaccinations, or other acute conditions such as fainting and headaches) than study non-participants. These results suggest that frequent use of local health care systems by children and parents may increase comfort levels with local physicians and physician researchers, thereby improving participation rates in research studies among these populations. However, special efforts may be necessary to improve research participation among children who are infrequent users of the health care systems of interest.

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Behavioral aspects of clinical trials: An integrated framework from behavior theory

Morrow

Hickok

Burish

1994

Cancer

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A less-than-optimal proportion of patients with cancer are entered into National Cancer Institute-sponsored clinical trials. This article reviews the literature on accrual in oncology clinical trials to characterize the extent of the problem, identify reasons for low accrual, and suggest ways to promote accrual. Four well known theories of health behavior (the Health Belief Model, Subjective Expected Utility Theory, Protection Motivation Theory, and the Theory of Reasoned Action) point to central concepts involved in understanding patient health-related behavior: (1) the probability that an unwelcomed health event will happen to a patient, (2) the severity of that event if it does occur, (3) the effectiveness of a particular behavior (such as taking part in a clinical trial) to modify the severity, and (4) the cost of adopting that behavior. These concepts form a framework for integrating the available information about accrual to clinical oncology trials. Patient and physician factors previously related to clinical trials suggest specific recommendations for increasing accrual to clinical oncology trials. Cancer 1994;742676-82.

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Participant Enrollment, Participation, and Compliance in Chemoprevention Trials

Cited by 13 publications

References 24 publications

Patient Participation and Compliance in Cancer Chemoprevention Trials: Issues and Concerns

Patient Participation and Compliance in Cancer Chemoprevention Trials: Issues and Concerns

Assessing participation bias in a population‐based study of measles‐mumps‐rubella vaccine immunity in children and adolescents aged 12–18

Behavioral aspects of clinical trials: An integrated framework from behavior theory

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