Patients want to know results of their clinical trials

Although an overwhelming 98% of cancer patients wanted to know the results of the clinical trial they took part in, there is currently no standard way of conveying the information. The onus is usually placed on the patient to find out the results from their doctor. Over 1,400 people with cancer took part in a new study to determine the best way of telling patients about their clinical trial results, the findings of which were announced today at the 5th European Breast Cancer Conference (EBCC-5).

The study by the TACT (Taxotere as Adjuvant ChemoTherapy) trial management group, questioned UK patients involved in clinical trials and asked if they would like to be notified of the results when available, and if so, how they would like the results conveyed. Advantages and disadvantages of each method were explained. A similar survey of health care professionals was conducted simultaneously.

Stella Kyriakides, Co-Chair of EBCC-5 and past president of Europa Donna comments, "Some breast cancer patients take part in a clinical trial and are never told the results. It is important that patients are not forgotten after they have participated in a study that ultimately improves cancer treatment for all patients."

The findings revealed that posting trial results directly to patients' homes was the preferred way to receive the information, with almost half indicating this method. Forty percent wanted to be told in person by a hospital doctor or nurse, with the rest preferring to be telephoned with the results.

The study found that health professionals, in contrast, favoured delivery of trial results through the patients' hospital - around 80% thought patients should receive results this way. Further, 42% of patients thought that the next of kin of deceased patients should be given the relevant results, however only 27% of healthcare professionals believed that this was a good idea.

It is often many years before the results of a clinical trial are available to patients, if at all. Large trials can take up to ten years to analyse and publish.

As clinical trial data is invariably published in medical journals the language is often complicated and full of medical terms. In fact 96% of health professionals surveyed requested that the information about trials be disseminated into lay language, for patients to understand.

In May 2004, the European Union introduced a Clinical Trials Directive. This covers many aspects of running clinical trials in Europe, including improving the reporting of clinical trials. It is hoped that the flow of clinical trial information will improve and guidelines implemented so that patients automatically gain trial results, in a format that they and their relatives will understand.

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Notes: Europa Donna, The European Breast Cancer Coalition was founded in 1994. It aims to raise awareness of breast cancer and improve breast services across Europe through advocacy and education. This non-profit organisation represents the concerns of European women to local and national authorities and also to governments and institutions of the European Union. Each country has its own national Europa Donna group called a forum. Currently there are 39 member countries. Europa Donna is a member of Cancer World. www.europadonna.org

Notes:
British Medical Association (BMA) guidelines state 'Dissemination of results from clinical trials is usually through publication in peer reviewed journals. It has become increasingly accepted that the patients who participated in the study should be informed of the study results where possible'.

For further information please contact:
Stéphanie Makin, Tonic Life Communications, stephanie.makin@toniclc.com

EBCC5 press office: Tuesday 21st March – Friday 24th March 2006
Tel: +33 4 93 92 84 02
Fax: +33 4 93 92 84 04

Catalognr: 142
PP2 Advocacy and education
How do patients want to learn of results of clinical trials? – results of a survey of 1431 breast cancer patients taking part in the
TACT Trial
L. Johnson1, P. Barrett-Lee2, P. Ellis3, J. Bliss1, on behalf of the TACT Trial Managment Group
1Institute of Cancer Research, Section of Clinical Trials, Sutton, United Kingdom
2Velindre Hospital, Department of Oncology, Cariff, United Kingdom
3Guy's & St Thomas' Hospital, Department of Medical Oncology, London, United Kingdom
Introduction: The Taxotere as Adjuvant ChemoTherapy (TACT) trial (ISRCTN79718493) randomised 4162 (4124 UK; 38 Belgian) early breast cancer patients to FECx4 followed by taxotere x4 vs standard anthracycline regimens of similar duration(FECx8 or epirubicinx4 followed by CMFx4).

Aim: to identify methods preferred by health care professionals (HCPs) and patients in clinical trials of conveying results to patients.

Method: A questionnaire circulated via hospitals to participating UK patients in autumn 2004 asked if they would like to be notified of trial results when available, and if so, how they would like results conveyed. Advantages and disadvantages of each method of conveying results were explained. A similar survey of participating HCPs was conducted simultaneously.

Results: 1431 (34.7% of UK trial population) patients returned questionnaires. 30 (2.1%) patients did not want trial results. Of 1395 (97.5%) patients who wanted results, 554 (39.7%) wanted to be told or given them by a hospital doctor or nurse; 664 (47.7%) wanted the trials office to post results to their home, 177 (12.7%) wanted to request results by telephone when available. 6 (0.4%) patients did not answer this question. 176 HCPs from 89 UK centres returned questionnaires. 169/176 (96%) HCPs wanted results written in lay terms for patients. 144/176 (81.8%) thought patients should receive results via their hospital. Of these, 75 (52.1%) preferred the hospital to send results by post rather than give them face to face. 598 (41.8%) patients thought next of kin of deceased patients should be told results, 543 (37.9%) did not, and 290 (20.3%) did not answer this question. If the deceased patient had not wanted results, responses to this question were 519 (36.3%), 309 (21.6%) and 603 (42.1%) respectively. 47 (26.7%) HCPs thought next of kin of deceased patients should receive results; 118 (67.0%) thought they should not; 11 (6.3%) did not respond. Where the patient had not wanted results, responses were 27 (15.3%), 16 (9.1%) and 133 (75.6%) respectively. Patient responses by UK region and age group will be presented.

Conclusion: Posting trial results directly to patients' homes was preferred by patients, although 2% of patients do not want them at all. Most HCPs want to disseminate trial results to patients, a method moderately well supported by patients. Mixed responses to questions concerning giving results to relatives of patients who have died suggests an ethical dilemma.


Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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