Green, S. orcid.org/0000-0002-2622-5377, Graham, C.D., Collinson, M. et al. (19 more authors) (2025) Assessing multidimensional fidelity in a pilot optimization trial: A process evaluation of four intervention components supporting medication adherence in women with breast cancer. Translational Behavioral Medicine, 15 (1). ibae066. ISSN 1869-6716
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s) 2024. This is an open access article under the terms of the Creative Commons Attribution License (CC-BY 4.0), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited. |
Keywords: | process evaluation; intervention fidelity; optimization trial; breast cancer; medication adherence; multiphase optimization strategy |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Health Sciences (Leeds) > Academic Unit of Primary Care (Leeds) |
Funding Information: | Funder Grant number NIHR National Inst Health Research NIHR300588 |
Depositing User: | Symplectic Publications |
Date Deposited: | 13 Nov 2024 09:53 |
Last Modified: | 10 Feb 2025 16:37 |
Status: | Published |
Publisher: | Oxford University Press |
Identification Number: | 10.1093/tbm/ibae066 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:219574 |