Assessing multidimensional fidelity in a pilot optimization trial : a process evaluation of four intervention components supporting medication adherence in women with breast cancer

Green, Sophie M.C. and Graham, Christopher D. and Collinson, Michelle and Ow, Pei Loo and Hall, Louise H. and French, David P. and Rousseau, Nikki and Wilkes, Hollie and Taylor, Christopher and Raine, Erin and Ellison, Rachel and Howdon, Daniel and Foy, Robbie and Walwyn, Rebecca E.A. and Clark, Jane and Parbutt, Catherine and Waller, Jo and Buxton, Jacqueline and Moore, Sally J.L. and Velikova, Galina and Farrin, Amanda J. and Smith, Samuel G. (2024) 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. ISSN 1869-6716 (In Press)

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Abstract

Background: 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 (MOST). Purpose: Guided by the National Institute of Health Behavior Change Consortium (NIH BCC) fidelity framework, we investigated fidelity of design, training, delivery, receipt, and enactment of four intervention components. Methods: Women prescribed AET (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). Results: Design: Each intervention component targeted unique BCTs, with some overlap. Training: All ten 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% to 94.3%). A median of 32.5/41 (range 11 to 41) text messages were delivered, but a system error prevented some messages being sent to 22/28 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. Conclusions: All intervention components demonstrated adequate fidelity. We have provided an exemplar for assessing fidelity using the NIH BCC framework, in the preparation phase of MOST.

ORCID iDs

Green, Sophie M.C., Graham, Christopher D. ORCID logoORCID: https://orcid.org/0000-0001-8456-9154, Collinson, Michelle, Ow, Pei Loo, Hall, Louise H., French, David P., Rousseau, Nikki, Wilkes, Hollie, Taylor, Christopher, Raine, Erin, Ellison, Rachel, Howdon, Daniel, Foy, Robbie, Walwyn, Rebecca E.A., Clark, Jane, Parbutt, Catherine, Waller, Jo, Buxton, Jacqueline, Moore, Sally J.L., Velikova, Galina, Farrin, Amanda J. and Smith, Samuel G.;
CORE (COnnecting REpositories)