Assessing multidimensional fidelity in a pilot optimization trial: A process evaluation of four intervention components supporting medication adherence in women with breast cancer.
No Thumbnail Available
All Authors
Green, SMC.
Graham, CD.
Collinson, M.
Ow, PL.
Hall, LH.
French, DP.
Rousseau, N.
Wilkes, H.
Taylor, C.
Raine, E.
LTHT Author
Green, Sophie
Clark, Jane
Parbutt, Catherine
Buxton, Jacqueline
Moore, Sally
Velikova, Galina
Clark, Jane
Parbutt, Catherine
Buxton, Jacqueline
Moore, Sally
Velikova, Galina
LTHT Department
Clinical & Health Psychology
Medicines Management & Pharmacy Services
Leeds Cancer Centre
Oncology
Medicines Management & Pharmacy Services
Leeds Cancer Centre
Oncology
Non Medic
Consultant Pharmacist
Research Nurse
Research Nurse
Publication Date
2025
Item Type
Journal Article
Randomized Controlled Trial
Randomized Controlled Trial
Language
Subject
Subject Headings
Abstract
Adherence to adjuvant endocrine therapy in women with breast cancer is low. We conducted a 24-1 fractional factorial pilot optimization trial to test four intervention components supporting medication adherence [text messages, information leaflet, acceptance and commitment therapy (ACT), self-management website], in the preparation phase of the multiphase optimization strategy. Guided by the National Institute of Health Behavior Change Consortium fidelity framework, we investigated fidelity of design, training, delivery, receipt, and enactment of four intervention components. Women prescribed adjuvant endocrine therapy (n = 52) were randomized to one of eight experimental conditions comprised of combinations of the four intervention components (ISRCTN: 10487576). We assessed fidelity using self-report data (4 months post-randomization), trial data, ACT session observations, behavior change technique (BCT) coding, and interviews with participants (n = 20) and therapists (n = 6). Design: Each intervention component targeted unique behavior change techniques with some overlap. Training: All 10 therapists passed the competency assessment. Delivery: All leaflets (27/27) and website (26/26) details were sent, and ACT procedural fidelity was high (85.1%-94.3%). A median of 32.5/41 (range 11-41) text messages were delivered, but a system error prevented some messages being sent to 22 of 28 participants. Receipt: Most participants [63.0% (ACT, leaflet) to 71.4% (text messages)] read all or at least some of the intervention components they were randomized to receive. Enactment was reported most positively for ACT. All intervention components demonstrated adequate fidelity. We have provided an exemplar for assessing fidelity using the National Institute of Health Behavior Change Consortium framework in the preparation phase of multiphase optimization strategy.
Journal
Translational Behavioral Medicine