Acceptability of Four Intervention Components Supporting Medication Adherence in Women with Breast Cancer: a Process Evaluation of a Fractional Factorial Pilot Optimization Trial.
Acceptability
Breast cancer
Factorial
Medication adherence
Process evaluation
Journal
Prevention science : the official journal of the Society for Prevention Research
ISSN: 1573-6695
Titre abrégé: Prev Sci
Pays: United States
ID NLM: 100894724
Informations de publication
Date de publication:
26 Jul 2024
26 Jul 2024
Historique:
accepted:
15
07
2024
medline:
27
7
2024
pubmed:
27
7
2024
entrez:
26
7
2024
Statut:
aheadofprint
Résumé
Adjuvant endocrine therapy (AET) reduces mortality in early-stage breast cancer, but adherence is low. We developed a multicomponent intervention to support AET adherence comprising: text messages, information leaflet, acceptance and commitment therapy (ACT), and side-effect website. Guided by the multiphase optimization strategy, the intervention components were tested in the ROSETA pilot optimization trial. Our mixed-methods process evaluation investigated component acceptability. The pilot optimization trial used a 2
Identifiants
pubmed: 39060840
doi: 10.1007/s11121-024-01711-9
pii: 10.1007/s11121-024-01711-9
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : National Institute for Health and Care Research
ID : NIHR300588
Organisme : Yorkshire Cancer Research
ID : L417
Pays : United Kingdom
Organisme : Manchester Biomedical Research Centre
ID : IS-BRC-1215-20007
Organisme : Manchester Biomedical Research Centre
ID : NIHR203308
Informations de copyright
© 2024. The Author(s).
Références
Bright, E. E., Finkelstein, L. B., Nealis, M. S., Genung, S. R., Wrigley, J., Gu, H. C. J., Schmiege, S. J., & Arch, J. J. (2023). A systematic review and meta-analysis of interventions to promote adjuvant endocrine therapy adherence among breast cancer survivors. Journal of Clinical Oncology, 41(28), 4548–4561. https://doi.org/10.1200/jco.23.00697
doi: 10.1200/jco.23.00697
pubmed: 37531593
Collins, L. M. (2018). Optimization of behavioral, biobehavioral, and biomedical interventions: The multiphase optimization strategy (MOST). Springer International Publishing.
doi: 10.1007/978-3-319-72206-1
Collins, L. M., Strayhorn, J. C., & Vanness, D. J. (2021). One view of the next decade of research on behavioral and biobehavioral approaches to cancer prevention and control: Intervention optimization. Translational Behavioral Medicine, 11(11), 1998–2008. https://doi.org/10.1093/tbm/ibab087
doi: 10.1093/tbm/ibab087
pubmed: 34850927
pmcid: 8634530
Early Breast Cancer Trialists Collaborative Group. (2011). Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: Patient-level meta-analysis of randomised trials. Lancet, 378(9793), 771–784. https://doi.org/10.1016/s0140-6736(11)60993-8
doi: 10.1016/s0140-6736(11)60993-8
Early Breast Cancer Trialists Collaborative Group. (2015). Aromatase inhibitors versus tamoxifen in early breast cancer: Patient-level meta-analysis of the randomised trials. Lancet, 386(10001), 1341–1352. https://doi.org/10.1016/s0140-6736(15)61074-1
doi: 10.1016/s0140-6736(15)61074-1
Green, S. M. C., French, D. P., Graham, C. D., Hall, L. H., Rousseau, N., Foy, R., Clark, J., Parbutt, C., Raine, E., Gardner, B., Velikova, G., Moore, S. J. L., Buxton, J., Collinson, M., Ellison, R., Wilkes, H., Hartley, S., Mason, E., Farrin, A., & Smith, S. G. (2022). Supporting adjuvant endocrine therapy adherence in women with breast cancer: The development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy. BMC Health Services Research, 22(1), 1081. https://doi.org/10.1186/s12913-022-08243-4
doi: 10.1186/s12913-022-08243-4
pubmed: 36002831
pmcid: 9404670
Green, S. M. C., Hall, L. H., Rousseau, N., French, D. P., Graham, C. D., Collinson, M., Mason, E., Wilkes, H., Howdon, D., Foy, R., Walwyn, R., Clark, J., Parbutt, C., Raine, E., Ellison, R., Buxton, J., Moore, S. J. L., Velikova, G., Farrin, A., & Smith, S. G. (2023). Acceptability, fidelity and trial experience of four intervention components to support medication adherence in women with breast cancer: A process evaluation protocol for a pilot fractional factorial trial. NIHR Open Research, 3, 3. https://doi.org/10.3310/nihropenres.13337.2
doi: 10.3310/nihropenres.13337.2
pubmed: 37881449
pmcid: 10593334
Hershman, D. L., Kushi, L. H., Shao, T., Buono, D., Kershenbaum, A., Tsai, W.-Y., Fehrenbacher, L., Lin Gomez, S., Miles, S., & Neugut, A. I. (2010). Early discontinuation and nonadherence to adjuvant hormonal therapy in a cohort of 8,769 early-stage breast cancer patients. Journal of Clinical Oncology, 28(27), 4120–4128. https://doi.org/10.1200/jco.2009.25.9655
doi: 10.1200/jco.2009.25.9655
pubmed: 20585090
pmcid: 2953970
Inotai, A., Ágh, T., Maris, R., Erdősi, D., Kovács, S., Kaló, Z., & Senkus, E. (2021). Systematic review of real-world studies evaluating the impact of medication non-adherence to endocrine therapies on hard clinical endpoints in patients with non-metastatic breast cancer. Cancer Treatment Reviews, 100, 102264. https://doi.org/10.1016/j.ctrv.2021.102264
doi: 10.1016/j.ctrv.2021.102264
pubmed: 34388473
Makubate, B., Donnan, P. T., Dewar, J. A., Thompson, A. M., & McCowan, C. (2013). Cohort study of adherence to adjuvant endocrine therapy, breast cancer recurrence and mortality. British Journal of Cancer, 108(7), 1515–1524. https://doi.org/10.1038/bjc.2013.116
doi: 10.1038/bjc.2013.116
pubmed: 23519057
pmcid: 3629427
Malterud, K., Siersma, V. D., & Guassora, A. D. (2016). Sample size in qualitative interview studies. Qualitative Health Research, 26(13), 1753–1760. https://doi.org/10.1177/1049732315617444
doi: 10.1177/1049732315617444
pubmed: 26613970
McCowan, C., Wang, S., Thompson, A. M., Makubate, B., & Petrie, D. J. (2013). The value of high adherence to tamoxifen in women with breast cancer: A community-based cohort study. British Journal of Cancer, 109(5), 1172–1180. https://doi.org/10.1038/bjc.2013.464
doi: 10.1038/bjc.2013.464
pubmed: 23949153
pmcid: 3778308
Moore, G. F., Audrey, S., Barker, M., Bond, L., Bonell, C., Hardeman, W., Moore, L., O’Cathain, A., Tinati, T., Wight, D., & Baird, J. (2015). Process evaluation of complex interventions: Medical Research Council guidance. British Medical Journal, 350, h1258. https://doi.org/10.1136/bmj.h1258
doi: 10.1136/bmj.h1258
pubmed: 25791983
pmcid: 4366184
Murphy, C. C., Bartholomew, L. K., Carpentier, M. Y., Bluethmann, S. M., & Vernon, S. W. (2012). Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: A systematic review. Breast Cancer Research and Treatment, 134(2), 459–478. https://doi.org/10.1007/s10549-012-2114-5
doi: 10.1007/s10549-012-2114-5
pubmed: 22689091
pmcid: 3607286
O’Cathain, A., Murphy, E., & Nicholl, J. (2010). Three techniques for integrating data in mixed methods studies. British Medical Journal, 341, c4587. https://doi.org/10.1136/bmj.c4587
doi: 10.1136/bmj.c4587
pubmed: 20851841
Sekhon, M., Cartwright, M., & Francis, J. J. (2017). Acceptability of healthcare interventions: An overview of reviews and development of a theoretical framework. BMC Health Services Research, 17(1), 1–13. https://doi.org/10.1186/s12913-017-2031-8
doi: 10.1186/s12913-017-2031-8
Sekhon, M., Cartwright, M., & Francis, J. J. (2022). Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Services Research, 22(1), 279. https://doi.org/10.1186/s12913-022-07577-3
doi: 10.1186/s12913-022-07577-3
pubmed: 35232455
pmcid: 8887649
Skivington, K., Matthews, L., Simpson, S. A., Craig, P., Baird, J., Blazeby, J. M., Boyd, K. A., Craig, N., French, D. P., McIntosh, E., Petticrew, M., Rycroft-Malone, J., White, M., & Moore, L. (2021). A new framework for developing and evaluating complex interventions: Update of Medical Research Council guidance. British Medical Journal, 374, n2061. https://doi.org/10.1136/bmj.n2061
doi: 10.1136/bmj.n2061
pubmed: 34593508
pmcid: 8482308
Smith, S. G., Ellison, R., Hall, L. H., Clark, J., Hartley, S., Mason, E., Metherell, J., Olivier, C., Napp, V., Naik, J., Buckley, S., Hirst, C., Hartup, S., Neal, R. D., Velikova, G., Farrin, A. J., Collinson, M., & Graham, C. D. (2022). 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. BMC Pilot and Feasibility Studies, 8(1), 33. https://doi.org/10.21203/rs.3.rs-679400/v1
doi: 10.21203/rs.3.rs-679400/v1
Smith, S. G., Green, S. M. C., Ellison, R., Foy, R., Graham, C. D., Mason, E., French, D. P., Hall, L. H., Wilkes, H., McNaught, E., Raine, E., Walwyn, R., Howdon, D., Clark, J., Rousseau, N., Buxton, J., Moore, S. J. L., Parbutt, C., Velikova, G., & Collinson, M. (2023). Refining and optimising a behavioural intervention to support endocrine therapy adherence (ROSETA) in UK women with breast cancer: Protocol for a pilot fractional factorial trial. British Medical Journal Open, 13(2), e069971. https://doi.org/10.1136/bmjopen-2022-069971
doi: 10.1136/bmjopen-2022-069971
Strayhorn, J. C., Collins, L. M., & Vanness, D. J. (2023). A posterior expected value approach to decision-making in the multiphase optimization strategy for intervention science. Psychological Methods. Advance online publication. https://doi.org/10.1037/met0000569 .
Tonkin-Crine, S., Anthierens, S., Hood, K., Yardley, L., Cals, J. W. L., Francis, N. A., Coenen, S., Van Der Velden, A. W., Godycki-Cwirko, M., Llor, C., Butler, C. C., Verheij, T. J. M., Goossens, H., & Little, P. (2015). Discrepancies between qualitative and quantitative evaluation of randomised controlled trial results: Achieving clarity through mixed methods triangulation. Implementation Science, 11(1), 66. https://doi.org/10.1186/s13012-016-0436-0
doi: 10.1186/s13012-016-0436-0
Vindrola-Padros, C., Brage, E., & Johnson, G. A. (2021). Rapid, responsive, and relevant?: A systematic review of rapid evaluations in health care. American Journal of Evaluation, 42(1), 13–27. https://doi.org/10.1177/1098214019886914
doi: 10.1177/1098214019886914
Vindrola-Padros, C., Chisnall, G., Polanco, N., & Juan, V. S. (2022). Iterative cycles in qualitative research: Introducing the RREAL sheet as an innovative process. SSRN Electronic Journal (Preprint). https://doi.org/10.2139/ssrn.4162797
doi: 10.2139/ssrn.4162797