An Analysis Of Patient Participation In A Breast Radiotherapy Clinical Trial


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Nicola Rivington1
1Portsmouth Hospitals Trust



I wanted to find out if there was any relationship between patient participation in the trial and five physical factors. The trial was divided into three groups. The control arm was standard breast radiotherapy treatment of 40Gy in 15 fractions and two test arms that received 26Gy or 27Gy in 5 fractions. A tumour bed boost would be delivered according to usual departmental policy. Trial participation was offered to 146 ladies; 92 consented and 54 declined,resulting in an uptake rate of 63%.


Analysis of uptake rates for these two groups of patients against five factors:

Laterality of breast treated

Requirement for a tumour bed boost of 5 further fractions


Prior chemotherapy treatment for their breast cancer

Distance from the patient’s home to the radiotherapy department


There was a significant difference in uptake according to laterality; right 74%, left 56%.

There was a significant difference in trial uptake according to the requirement for a boost, 78% of boost patients consented to the trial whereas 58% of non boost patients declined.

There was no linear relationship between age and trial uptake, although there was a significantly higher uptake in the 46-55yr group.

There was no correlation between chemotherapy treatment and trial uptake.

There was no correlation between increased distance to travel and trial uptake.


There is no strong evidence to suggest that any one of these factors solely influenced trial participation. There are too many variables to draw meaningful conclusions. For example the majority of patients requiring a boost are in the age range of highest trial uptake. We cannot conclude which factor, if any, may have influenced the patient’s decision.

My conclusion is that it is the patient’s individual assessment of risk versus benefit that determines their decision to participate.