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Table 5 Primary and secondary endpoints recorded within the ACTION trial

From: Acceptance and Commitment Therapy to support medication decision-making and quality of life in women with breast cancer: protocol for a pilot randomised controlled trial

Primary endpoints

Secondary endpoints

Number of patients screened for eligibility

Intervention adherence for patients in the intervention arm (number of sessions attended, number of participants in group sessions, whether homework was completed, reasons for non-attendance/non-compliance)

Number and proportion of patients eligible out of those screened and reasons for ineligibility

Website use (tracking data to include number of visits, pages visited, materials downloaded, videos watched, clicked links)

Number and proportion of patients consenting to randomisation out of those eligible and reasons for non-randomisation

Number of patients deemed as having completed the intervention

Number of participants randomised per site per month

Treatment as usual content in both arms from participants (number of sessions attended and content of sessions) and sites (initiatives implemented during the trial)

Questionnaire completion rates at each time-point

Safety (deaths, hospitalisations related to the intervention, RUSAEs)

Number of items of missing data per questionnaire at each time-point

Acceptability of the ACTION intervention to participants (acceptability and B&N questionnaires)

Number and proportion of randomised participants lost-to-follow-up

Number, proportion and timing of therapist withdrawals and reasons for withdrawal

Number, proportion, type and timing of participant withdrawals out of those randomised and reasons for withdrawal

Qualitative study

 

Competency and fidelity of the delivery of the ACT intervention by NHS therapists (ACTKQ, ACT-FM, Procedural fidelity checklist)

 

“Proof-of-principle” exploration in outcome and process variables

 

Estimation of the intracluster correlation coefficient