Feasibility
fatigue, cancer, Breast cancer, pain, nausea,
CANCER, BREAST CANCER, RECRUITMENT, BREAST CANCER
The recruitment rate for this study was 32.5%. A recent systematic review of recruitment rates in cancer-related trials identified a median recruitment rate of 38% and cited similar reasons as identified in this current study for lack of participation, such as difficulty with travel and lack of interest [The retention rate in this study (77.5%) is considered acceptable for an RCT with a three-month follow-up. The loss of study participants to follow-up can introduce bias and impact on the generalisability, validity and reliability of study findings [The majority of study participants were women with breast cancer. Breast cancer is one of the most prevalent cancer types internationally and accounts for 29% of all cancer types in Ireland [In total, seven men participated in the current study. The low uptake of self-management programmes by men was highlighted by Galdas et al. [A high attendance rate by the intervention group indicates that OptiMal was an acceptable intervention with 73% of the intervention group attending all six sessions of OptiMal. Weekly attendance involved considerable commitment from participants as they were required to attend for 2.5 h/week in addition to time required for travelling to and from the intervention centre. Participants were also required to work on weekly goals related to implementation of self-management strategies between weekly sessions. However, the high levels of attendance would indicate that this time commitment was not considered problematic by intervention participants. Qualitative interviews completed as part of this current study supported this finding with intervention participants reporting high acceptability of the content, intervention format, duration and time commitment [Demographic and clinical characteristics were compared for those who completed the study and those who were lost to follow-up in both the intervention and control group participants. The only significant difference between completers and non-completers in the intervention group was the self-reported presence of chronic conditions for all non-completers (100%). Chronic conditions present a wide range of disease-specific symptoms such as nausea, pain, fatigue and distress that may exacerbate cancer-related symptoms. This finding indicates that future studies of OptiMal should screen for the impact of chronic conditions, including symptom severity, and include an assessment of the impact of disease-specific symptoms on participants’ physical and psychological health. Assessment findings could then be used to tailor the content and delivery format of OptiMal to accommodate individuals with chronic conditions. The presence of chronic conditions may also impact on ability to participate in longitudinal studies, and therefore, the study team may also need to provide additional supports to retain study participants with chronic conditions.For the control group, the only significant difference between completers and non-completers was that a higher proportion of the non-completers were between 12 and 24 months since completion of their treatment. Perhaps, given the time since completing treatment, these individuals had resumed pre-diagnosis activities and roles such as returning to work and therefore could not prioritise participation in the study over these activities. This further supports the need to tailor intervention delivery and format and employ a range of strategies to retain participants in intervention trials. Such strategies include flexibility in intervention delivery, regular communication from the study team and reimbursement for travel and time [There were no other significant differences in the demographic characteristics of age, marital status, employment and education levels for completers and non-completers in both arms. This is in contrast with previous research that reported these variables can influence participation in self-management interventions trials [