Table 1 Feasibility and acceptability outcomes
Outcome | Measure |
|---|---|
Recruitment rate | |
 Interest | Percentage of those potentially eligible (from medical records and clinician approval) who are interested and willing to answer further eligibility questions. |
 Enrolment | Percentage of participants who are interested and eligible who are randomised. |
Acceptability of randomisation | The percentage of participants who withdraw upon being informed of allocation (within 1 week of randomisation). The percentage of potential participants who state that randomisation is their reason for declining to participate. |
Feasibility of administering the intervention | The percentage of the intervention group who: - receive a behavioural support call. - self-report successfully downloading the app. |
Acceptability of the intervention | Percentage of participants who report that no aspect of the intervention (leaflet, call, planner, app) was useful. Percentage of withdrawals from intervention group compared to control group. Percentage of reasons for withdrawal relating to the intervention. |
Retention rate | The percentage of participants, in each group, who complete any of the T1 follow-up assessment measures. |
Acceptability of outcome assessments | The percentage of participants who consent who complete any baseline assessments. Completion rates, in each group, for each of the assessments at: - baseline - follow-up |
Willingness of participants to consent to linkage with HES/NCRAS registries for long-term follow-up | The percentage of participants who consent for this aspect of the study. |
Acceptability of online assessments | The percentage of participants who require help from a researcher to complete questionnaires. The percentage of potential participants who give this method of data collection as a reason for declining to participate. |
Acceptability of providing informed consent online | The percentage of potential participants that state that they are unable/unwilling to provide consent online. |
Self-reported app usage and engagement | Percentage of participants in the intervention group who report using the app for less than a month. |
The proportion of screened participants ineligible and reasons for ineligibility | The number of participants screened and deemed ineligible for each inclusion/exclusion criteria. |
Potential sociodemographic biases in recruitment | Anonymised aggregate socio-demographics (age, gender, ethnicity, Index of Multiple Deprivation, cancer type, cancer stage, time since diagnosis, treatment completed and started) of potentially eligible participants (from medical records and clinician approval) who did not participate in the trial compared with the study sample characteristics. |
Fidelity of intervention delivery in the telephone/video calls | Average percentage of required behaviour change techniques covered in 25% of participants’ intervention calls (randomly selected) scored against a checklist. |
Contamination of the control group | The percentage of participants in the control group who report: • using Active 10 during the study period. • that a health professional recommended Active 10 to them during the study period. |