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Table 2 Study protocol amendments made to address recruitment issues

From: Peer support to maintain psychological wellbeing in people with advanced cancer: findings from a feasibility study for a randomised controlled trial

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.