Informing breast cancer patients about clinical trials:a randomized clinical trial of an educational booklet
Annals of OncologyPublished 1 September 2002Open access
Peter Ellis, Phyllis Butow, Martin H.N. Tattersall
Citations68
SJR quartileQ1
SJR score19.07
SNIP10.48
Generate an AI Snapshot to get a quick, structured summary of this paper.
Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
A concise AI-generated summary of the paper will appear here once you click Generate AI Snapshot.
TL;DR
Educating women about clinical trials in this manner appears ineffective in improving recruitment to RCTs, and women appear to be more influenced by their perception of risk than understanding.
Abstract
Educating women about clinical trials in this manner appears ineffective in improving recruitment to RCTs. Women appear to be more influenced by their perception of risk than understanding. This finding has ethical implications for communication of information about RCTs.
Keywords
MedicineHealth ProfessionsBiochemistry, Genetics and Molecular Biology
Acta Psychiatrica ScandinavicaThe Hospital Anxiety and Depression Scale
46,617 Citations1983A. S. Zigmond, R. P. Snaith
It is suggested that the introduction of the scales into general hospital practice would facilitate the large task of detection and management of emotional disorder in patients under investigation and treatment in medical and surgical departments.
New England Journal of MedicineEquipoise and the Ethics of Clinical Research
2,305 Citations1987Benjamin Freedman
An alternative concept of equipoise is suggested, which would be based on present or imminent controversy in the clinical community over the preferred treatment, which is satisfied if there is genuine uncertainty within the expert medical community--not necessarily on the part of the individual investigator--about the preferredreatment.
Annals of Internal MedicineInformation and Participation Preferences Among Cancer Patients
1,142 Citations1980Barrie R. Cassileth, ROBERT V. ZUPKIS +2 more
Most patients in each age group displayed high levels of hope, preferences for open communication about their illness, and a desire for maximum amounts of information.
Journal of Clinical EpidemiologyDecision making during serious illness: What role do patients really want to play?
1,009 Citations1992Lesley F. Degner, Jeffrey A. Sloan
It is suggested that the impact of being diagnosed with a life-threatening illness may influence preferences to participate, and the majority of patients and members of the public wanted their physician and family to share responsibility for decision making if they were too ill to participate.
The British Journal of PsychiatryThe Factor Structure and Factor Stability of the Hospital Anxiety and Depression Scale in Patients with Cancer
651 Citations1991Stirling Moorey, Steven Greer +6 more
New England Journal of MedicineInformed Consent — Why Are Its Goals Imperfectly Realized?
530 Citations1980Barrie R. Cassileth, Robert V. Zupkis +2 more
Although most thought that consent forms were necessary and comprehensible and that they contained worthwhile information, the legalistic connotations of the forms appeared to lead to cursory reading and inadequate recall.
Journal of Clinical OncologyRandomized Clinical Trials in Oncology: Understanding and Attitudes Predict Willingness to Participate
248 Citations2001Peter M. Ellis, Phyllis Butow +3 more
It is suggested that women who have a better understanding of issues about clinical trials have more favorable attitudes toward randomized trials and are more willing to consider participation in a clinical trial.
Journal of Clinical OncologyAre informed consent forms that describe clinical oncology research protocols readable by most patients and their families?
217 Citations1994Stuart A. Grossman, S Piantadosi +1 more
Assessment of informed consent forms that describe clinical oncology protocols found that they are written at a level that is difficult for most patients to read, despite national, cooperative group, institutional, and departmental review.
Annals of OncologyPatient participation in the cancer consultation: Evaluation of a question prompt sheet
215 Citations1994Phyllis Butow, Stewart M. Dunn +2 more
A question prompt sheet has a limited but important effect on patient question asking behaviour in the cancer consultation.
British Journal of CancerPromoting patient participation in the cancer consultation: evaluation of a prompt sheet and coaching in question-asking
208 Citations1999Rhonda Brown, Phyllis Butow +2 more
It is concluded that a question prompt sheet addressed by the doctor is a simple, inexpensive and effective means of promoting patient question asking in the cancer consultation.
BMJRandomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer.
203 Citations1986R. J. Simes, Martin H.N. Tattersall +4 more
A randomised study was performed to compare two commonly adopted methods of seeking consent to randomised treatment: an individual approach at the discretion of each doctor and a uniform policy of total disclosure of all relevant information.
Journal of Clinical OncologyTelephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials.
184 Citations1996N.K. Aaronson, E Visser-Pol +9 more
The use of a supplementary, telephone-based nursing intervention is a feasible and effective means to increase cancer patients' awareness and understanding of the salient issues that surround the clinical trials in which they are asked to participate.
BMJThe ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals
175 Citations1998SE Edwards, Richard Lilford +1 more
What patients, the general public, and healthcare professionals thought about trials was reviewed from these perspectives as part of a broader review relating to the ethics of designing and conducting clinical trials.
Journal of Clinical OncologyGeneral information tapes inhibit recall of the cancer consultation.
155 Citations1993Stewart M. Dunn, Phyllis Butow +5 more
It is concluded that individual audiotapes have a limited potential to increase recall of information from the oncology consultation and general information tapes about cancer appear to inhibit recall actively.
Patient Education and CounselingDeterminants of patient participation in clinical studies requiring informed consent: Why patients enter a clinical trial
148 Citations1998Frank W.S.M. Verheggen, Fred Nieman +1 more
Motivating beliefs on the relevance to reducing the threat to the patient's health condition ('values') and the evaluations of the clinical trial the patient is approached for ('expectancy'), are relevant in explaining patient behavior.
Social Science & MedicineParental perceptions and attitudes about informed consent in clinical research involving children
143 Citations1995S. C. HARTH, Y.H. Thong
There may be significant attitudinal barriers to parental understanding of the informed consent process, and a significant minority offered the view that the strict informed consent procedures followed were unnecessary because they would do what the doctor advised.
DigitalGeorgetown (Georgetown University Library)Introducing new treatments for cancer : practical, ethical and legal problems
132 Citations1992C J Williams
Partial table of contents: Ethics and consent, legal Aspects of Clinical Trials in the United Kingdom, and Good Clinical Research Practice.
European Journal of CancerAttitudes of patients to randomised clinical trials of cancer therapy
120 Citations1998Lesley Fallowfield, Valerie Jenkins +4 more
The results show that the majority of subjects 287 (91.1%) believe that patients should be asked to take part in medical research, but only 242 (76.8%) would be prepared toTake part in a study comparing two treatments if treatment was randomised, and 119 (68.4%) of the 174 who initially said 'no' to randomisation or who were unsure, would change their minds and takePart in a trial.
Heart & LungEffects of timing and reinforcement of preoperative education on knowledge and recovery of patients having coronary artery bypass graft surgery.
112 Citations1991Cupples Sa
Investigation of resting metabolic rates of cottonmouths found that maintenance metabolism alone during brumation is more costly near the northern range limit, but is most likely not a limiting factor in geographic distribution and may be used to fuel important processes other than activity metabolism.
Medical Decision MakingEffects of 0utcome Framing on Treatment Decisions in the Real World
104 Citations1989Laura A. Siminoff, John H. Fetting
It is concluded that the impact of outcome framing in real clinical situations is attenuated by verbal presentation of information and other factors more important to the decision process.
Journal of Clinical OncologyCancer by another name: a randomized trial of the effects of euphemism and uncertainty in communicating with cancer patients.
97 Citations1993Stewart M. Dunn, Pandora Patterson +4 more
Use of the word cancer generated anxiety to levels similar to those reported in general medical and surgical patients, but did not produce any distortion in reported adjustment, however, any ambiguity associated with the conditions under which adjustment is assessed may lead to distortion and an increase in the patient's reported psychologic distress.
European Journal of CancerInformed consent in European multicentre randomised clinical trials — Are patients really informed?
91 Citations1994Carmen J. Williams, Matjaž Zwitter
Examination of the standard of consent used by investigators in European randomised clinical trials found that clinicians in northern Europe were more likely to obtain full consent than those from southern Europe and the level of consent was higher in trials of supportive care than in trials testing curative or palliative antitumour therapies.
PubMedRandomized controlled trial of an educational booklet for patients presenting with back pain in general practice.
87 Citations1989Martín Roland, M Dixon
The results suggest that the booklet had some effect in altering both the knowledge and behaviour of patients with back pain.
The LancetNew approach for recruitment into randomised controlled trials
79 Citations1993Michael Baum
Health ExpectationsAttitudes to randomized clinical trials amongst out‐patients attending a medical oncology clinic
75 Citations1999Peter M. Ellis, Sharon M. Dowsett +2 more
To assess the understanding of and attitudes towards randomized clinical trials amongst patients attending oncology out‐patient clinics, a large number of patients attending out-patient clinics believe that randomized trials should be conducted.
Journal of Clinical OncologyEffect of patients' expectations of benefit with standard breast cancer adjuvant chemotherapy on participation in a randomized clinical trial: a clinical vignette study.
75 Citations1990John H. Fetting, Laura A. Siminoff +4 more
Multivariate logistic regression suggested that the benefit expected from CMF was more important than how benefit was described in treatment selection, and assured realistic patient expectations of standard adjuvant therapy benefit is likely to be important during discussion of clinical trials.
Journal of the Royal Society of MedicineAre We Getting Informed Consent from Patients with Cancer?
66 Citations1990Heather J. Sutherland, Gina Lockwood +1 more
It appears that many decisions regarding trial entry may be based upon incomplete or incorrect information.
European Journal of CancerResults of an intervention study to improve communication about randomised clinical trials of cancer therapy
63 Citations2001Anne Fleissig, Valerie Jenkins +1 more
Results from an intervention study to improve communication during consultations about randomised clinical trials of cancer therapy show that most patients agreed to trial entry and this was predicted by the Patient's Attitudes to Trials questionnaire with an 80.4% accuracy.
Seminars in Reproductive MedicineEthics of Clinical Trials
57 Citations1996Steven F. Palter
The changing nature of health care delivery in the United States introduces new outside interests into the doctor-patient relationship, and there is a long history of disregard for individual rights of the patient in this context.
Annals of OncologyThe adequacy of consent forms for informing patients entering oncological clinical trials
57 Citations1995Ian Olver, Logan Buchanan +2 more
The impact on 100 patients of information and consent forms signed prior to medical oncology clinical trials was evaluated by a survey at a subsequent visit and patients with a better ECOG performance status were more likely to find the form very helpful.
BMJRandomised controlled trial of educational package on management of menorrhagia in primary care: the Anglia menorrhagia education study
54 Citations1999Guy Fender, Andrew Prentice +5 more
The educational package positively influenced referral for menorrhagia and treatment with appropriate non-hormonal drugs, and no overall difference in norethisterone treatment compared with controls.
Journal of Surgical OncologyBreast cancer patients' personality style, age, and treatment decision making
54 Citations1996Julie Johnson, Cleora S. Roberts +4 more
Some authors suggest that patient personality style is an important consideration in decisional preference in breast cancer patients.
PubMedInformed consent: a crucial step in cancer patient education.
54 Citations1984Barbara K. Rimer, Wendy L. Jones +3 more
A study of informed consent to cancer treatment conducted at the Fox Chase Cancer Center in which the consultation between the patient and physician was observed and patients were interviewed found that patients recalled less than 40% of what they were told.
Lara D. VeekenSINGLE-BLIND RANDOMIZED CONTROLLED TRIAL OF AN EDUCATIONAL BOOKLET FOR PATIENTS WITH CHRONIC ARTHRITIS
48 Citations1996Fiona Maggs, R. W. Jubb +1 more
Increased knowledge was not associated with improved clinical status and no group showed a significant change in NHP or HAQ scores, but nearly all patients said they found the booklet useful.
Cambridge Quarterly of Healthcare EthicsBeneficence, Scientific Autonomy, and Self-Interest: Ethical Dilemmas in Clinical Research
46 Citations1992Edmund D. Pellegrino
The ethics of clinical research may be viewed from three different perspectives: the process of acquiring new knowledge, the moral use of the knowledge acquired, and the ethics of the investigator seeking this knowledge.
Australian and New Zealand Journal of Public HealthFocus group interviews examining attitudes to randomised trials among breast cancer patients and the general community
45 Citations1998Peter M. Ellis, Phyllis Butow
The knowledge of, and attitudes towards, randomised clinical trials among women in the community and breast cancer patients are explored to explore the knowledge of and attitude towards randomised trials.
PubMedA randomized controlled trial of an information booklet for hypertensive patients in general practice.
35 Citations1987Chris Watkins, Olia Papacosta +2 more
The information booklet evaluated in this study provides health professionals with a highly acceptable method of informing the patient about hypertension and its management and could be used both in hospital and general practice.
British Journal of Oral and Maxillofacial SurgeryThe use of an information leaflet for patients undergoing wisdom tooth removal
33 Citations1996P. O’Neill, Gerry Humphris +1 more
Journal of Clinical EpidemiologyAn empirical approach to informed consent in ovarian cancer
32 Citations1996Deb Feldman‐Stewart, Sergio Mestieri Chammas +3 more
Physicians treating ovarian cancer patients, women treated for the disease, and well lay women imagining themselves to have the disease used a visual analog scale to judge the importance of 57 questions that they might want answered before treatment decisions are made.
Cancer InvestigationOffering the Option of Randomized Clinical Trials to Cancer Patients Who Overestimate Their Prognoses with Standard Therapies
30 Citations1993John M. Sheldon, John H. Fetting +1 more
If impracticality is to be avoided and yet the approach fostered, clinical investigators might consider developing trial-specific, written or audiovisual materials for patient education about general background information to enable physicians to focus on more sensitive subjects, such as prognosis with standard therapy.
PubMedEvaluation of the National Cancer Institute's clinical trials booklet.
25 Citations1993Davis Sw, Nealon Eo +1 more
A posttest evaluation of the booklet "What Are Clinical Trials All About?" was conducted, designed to help cancer patients make informed decisions about participation in clinical trials, which are critical for improving cancer treatment.
Patient Education and CounselingSix-month follow-up of effects of an information programme for patients with malignant melanoma
23 Citations1996Yvonne Brandberg, Mia Bergenmar +3 more
Journal of Medical EthicsClinical trials--a brave new partnership?
21 Citations1994H Thornton
The need for informed consent is considered from the patient's viewpoint by an examination of the shortcomings of the UK Ductal Carcinoma In Situ trial and its failure satisfactorily to accrue both profession and patient.
Journal of Medical EthicsClinical trials -- a brave new partnership: a response to Mrs. Thornton.
18 Citations1994Michael Baum
This commentary on the previous paper explained that screen-detected Duct Carcinoma In Situ is effectively a new disease of unknown natural history and it is therefore both in the patient and the public's best interests that such cases are submitted to the rigours of the randomised controlled trial.
Journal of Internal MedicineElements of informed consent in clinical research with drugs: a survey of Spanish clinical investigators
6 Citations1992Rafael Dal‐Ré
Responses obtained are in line with most of the elements of informed consent regarded as ‘basic’ in US regulations and included in the European Community and Nordic Good Clinical Practice guidelines.
PubMedAre clinical trials in general practice ethical?
2 Citations1993L Scoles, Chris Silagy
Some of the ethical issues facing doctors and patients and some of the safeguards that are in place to protect both parties as the trial proceeds are explored.
