Trial reportTranslational behavioral medicine2025
Assessing multidimensional fidelity in a pilot optimization trial: A process evaluation of four intervention components supporting medication adherence in women with breast cancer.
Trial report in Translational behavioral medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Article
- Article
Corrections and comments
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Authors and funding
22 authors.
Funding
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.