pad

Patients' Decisions and Tamoxifen

ABSTRACT: Tamoxifen beyond 5 years: Patients' decisions regarding entry to the aTTom trial

The aim of this study was to assess among a population of women who had taken adjuvant tamoxifen for 5 years, how many were prepared to enter a randomised trial looking at the duration of tamoxifen treatment and what was the preference of those who declined trial entry. There is uncertainty as to the optimum duration of adjuvant tamoxifen and this is the subject of the aTTom (adjuvant Tamoxifen Treatment offer more?) trial in which patients are randomised to continue or stop tamoxifen after 5 years.

Patients have been recruited to the aTTom trial in Dundee since 1996 and a record has been kept of all the patients with whom the trial was discussed. Patients who declined trial entry were allowed to choose whether to electively stop or continue tamoxifen. 306 patients were eligible for trial entry of whom 171 (56%) consented to randomisation (82 to continue and 89 to stop). Amongst the 135 (44%) who declined randomisation, 28 (21%) elected to stop tamoxifen treatment, 90 (67%) elected to continue and in 17 (13%) their decision was unclear.

These results illustrate that patients eligible for the aTTom trial share our clinical equipoise. A majority (56%) of patients were agreeable to randomisation, but among those who declined, some (67%) preferred to continue, some (21%) to stop tamoxifen.

This trial is unusual in that the patients have already experienced the treatment options, so the patients' preferences reflect a truly informed choice.

[09/18/2002; European Journal of Cancer]

Ann's NOTE: One of the 'buzz' word phrases that go around at medical meetings is 'paradigm-shift'. The idea is that something really new is needed-a completely different way of looking at what is.

Naturally any one with a completely new and different idea is laughed, scorned or asked to wait.

One of my ideas was to allow patients to choose which arm of a trial they want to be in. Actually I suggested started with a study of randomization. Randomization is when people are assigned to a particular treatment/intervention when they agree to participate in a clinical trial or study.

Since there are many problems in recruiting people to join trials, I thought this might be a way of responding to the problem of people having a particular interest in one treatment or another (obviously this could not work in trials where one group (arm) got a placebo while the other got treatment.

Also, being able to make a CHOICE may benefit people and this needs to be explored also. Cancer is so much about losing control of your body that this may be another way to answer that.

Remember we are NOT Doctors and have NO medical training.

This site is like an Encylopedia - there are many pages, many links on many topics.

Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.