Table 2 Study protocol amendments made to address recruitment issues
Concern | Amendment made | Timescale |
|---|---|---|
Clinicians and patients potentially concerned or distressed about the term ‘advanced cancer’ used in the approved (by our PPI and the REC) study recruitment materials. | The term ‘advanced cancer’ removed from materials and replaced with ‘cancer’. | Amendment approved month 5 of recruitment |
The study was hard to quickly introduce and explain in a busy clinic environment | A quick-read bi-fold summary leaflet was prepared, worded and laid out according to PPI feedback, attached to the outside of the recruitment pack. | Amendment approved month 5 of recruitment |
Most potential participants were taking a recruitment pack in clinic, but not responding to the research team. | Telephone follow up by the research nurse teams at the recruiting sites added. | Amendment approved month 9 of recruitment. |
Cancer centre clinics may not be the most appropriate place to recruit participants for this type of study. | Hospices added as recruitment sites | Amendment approved month 11 of recruitment. |