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 [version 2; peer review: 2 approved]
Background: The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These are (a) text messages, (b) information leaflet...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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F1000 Research Ltd
2023-04-01
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| Series: | NIHR Open Research |
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| Online Access: | https://openresearch.nihr.ac.uk/articles/3-3/v2 |
| _version_ | 1797826538396188672 |
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| author | Louise H. Hall Sophie M.C. Green David P. French Nikki Rousseau Michelle Collinson Christopher D. Graham Hollie Wilkes Ellen Mason Robbie Foy Daniel Howdon Jane Clark Rebecca Walwyn Erin Raine Catherine Parbutt Jacqueline Buxton Rachel Ellison Galina Velikova Sally J. L. Moore Samuel G. Smith Amanda Farrin |
| author_facet | Louise H. Hall Sophie M.C. Green David P. French Nikki Rousseau Michelle Collinson Christopher D. Graham Hollie Wilkes Ellen Mason Robbie Foy Daniel Howdon Jane Clark Rebecca Walwyn Erin Raine Catherine Parbutt Jacqueline Buxton Rachel Ellison Galina Velikova Sally J. L. Moore Samuel G. Smith Amanda Farrin |
| author_sort | Louise H. Hall |
| collection | DOAJ |
| description | Background: The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These are (a) text messages, (b) information leaflet, (c) Acceptance and Commitment Therapy-based guided self-help (ACT), (d) side-effect management website. Guided by the Multiphase Optimisation Strategy, our pilot trial will use a fractional factorial design to evaluate the feasibility of undertaking a larger optimisation trial. The pilot will include a process evaluation to maximise learning regarding the fidelity and acceptability of the intervention components before proceeding with a larger trial. The trial process evaluation has three aims: to assess the (1) fidelity and (2) acceptability of the intervention components; and (3) to understand participant’s trial experience, and barriers and facilitators to recruitment and retention. Methods: The process evaluation will use multiple methods. Fidelity of the intervention components will be assessed using self-reported questionnaire data, trial data on intervention component adherence, and observations of the ACT sessions. Acceptability of the intervention components and trial experience will be explored using an acceptability questionnaire and interviews with patients and trial therapists. Trial experience will be assessed using a questionnaire and interviews with participants, while barriers and facilitators to recruitment and retention will be assessed using a questionnaire completed by research nurses and participant interviews. The pilot trial opened for recruitment on 20th May 2022 and was open at the time of submission. Conclusions: This process evaluation will provide information regarding whether the intervention components can be delivered with fidelity within a national healthcare setting and are acceptable to participants. We will also better understand participant experience in a pilot trial with a fractional factorial design, and any barriers and facilitators to recruitment and retention. Registration: ISRCTN registry (ISRCTN10487576, 16/12/2021). |
| first_indexed | 2024-04-09T12:33:59Z |
| format | Article |
| id | doaj.art-19730c8a831c42e2af55464031472e2c |
| institution | Directory Open Access Journal |
| issn | 2633-4402 |
| language | English |
| last_indexed | 2024-04-09T12:33:59Z |
| publishDate | 2023-04-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | NIHR Open Research |
| spelling | doaj.art-19730c8a831c42e2af55464031472e2c2023-05-16T00:00:00ZengF1000 Research LtdNIHR Open Research2633-44022023-04-01314552Acceptability, 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 [version 2; peer review: 2 approved]Louise H. Hall0Sophie M.C. Green1https://orcid.org/0000-0002-2622-5377David P. French2https://orcid.org/0000-0002-7663-7804Nikki Rousseau3Michelle Collinson4Christopher D. Graham5Hollie Wilkes6Ellen Mason7Robbie Foy8https://orcid.org/0000-0003-0605-7713Daniel Howdon9https://orcid.org/0000-0001-8052-2893Jane Clark10https://orcid.org/0009-0007-1882-666XRebecca Walwyn11Erin Raine12Catherine Parbutt13Jacqueline Buxton14Rachel Ellison15https://orcid.org/0000-0001-9251-492XGalina Velikova16Sally J. L. Moore17Samuel G. Smith18Amanda Farrin19Leeds Institute of Health Sciences, University of Leeds, Leeds, LS29NL, UKLeeds Institute of Health Sciences, University of Leeds, Leeds, LS29NL, UKManchester Centre for Health Psychology, University of Manchester, Manchester, M13 9PL, UKLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29NL, UKLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29NL, UKDepartment of Psychology, Queen's University Belfast, Belfast, BT9 5BN, IrelandLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29NL, UKLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29NL, UKLeeds Institute of Health Sciences, University of Leeds, Leeds, LS29NL, UKLeeds Institute of Health Sciences, University of Leeds, Leeds, LS29NL, UKDepartment of Clinical and Health Psychology, Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UKLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29NL, UKLeeds Institute of Health Sciences, University of Leeds, Leeds, LS29NL, UKMedicines Management and Pharmacy Services, Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UKIndependent Researcher, Leeds, UKLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29NL, UKLeeds Institute of Medical Research at St James’s, University of Leeds, Leeds, LS9 7TF, UKIndependent Researcher, Leeds, UKLeeds Institute of Health Sciences, University of Leeds, Leeds, LS29NL, UKLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29NL, UKBackground: The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These are (a) text messages, (b) information leaflet, (c) Acceptance and Commitment Therapy-based guided self-help (ACT), (d) side-effect management website. Guided by the Multiphase Optimisation Strategy, our pilot trial will use a fractional factorial design to evaluate the feasibility of undertaking a larger optimisation trial. The pilot will include a process evaluation to maximise learning regarding the fidelity and acceptability of the intervention components before proceeding with a larger trial. The trial process evaluation has three aims: to assess the (1) fidelity and (2) acceptability of the intervention components; and (3) to understand participant’s trial experience, and barriers and facilitators to recruitment and retention. Methods: The process evaluation will use multiple methods. Fidelity of the intervention components will be assessed using self-reported questionnaire data, trial data on intervention component adherence, and observations of the ACT sessions. Acceptability of the intervention components and trial experience will be explored using an acceptability questionnaire and interviews with patients and trial therapists. Trial experience will be assessed using a questionnaire and interviews with participants, while barriers and facilitators to recruitment and retention will be assessed using a questionnaire completed by research nurses and participant interviews. The pilot trial opened for recruitment on 20th May 2022 and was open at the time of submission. Conclusions: This process evaluation will provide information regarding whether the intervention components can be delivered with fidelity within a national healthcare setting and are acceptable to participants. We will also better understand participant experience in a pilot trial with a fractional factorial design, and any barriers and facilitators to recruitment and retention. Registration: ISRCTN registry (ISRCTN10487576, 16/12/2021).https://openresearch.nihr.ac.uk/articles/3-3/v2process evaluation intervention fidelity acceptability trial experience fractional factorialeng |
| spellingShingle | Louise H. Hall Sophie M.C. Green David P. French Nikki Rousseau Michelle Collinson Christopher D. Graham Hollie Wilkes Ellen Mason Robbie Foy Daniel Howdon Jane Clark Rebecca Walwyn Erin Raine Catherine Parbutt Jacqueline Buxton Rachel Ellison Galina Velikova Sally J. L. Moore Samuel G. Smith Amanda Farrin 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 [version 2; peer review: 2 approved] NIHR Open Research process evaluation intervention fidelity acceptability trial experience fractional factorial eng |
| title | 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 [version 2; peer review: 2 approved] |
| title_full | 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 [version 2; peer review: 2 approved] |
| title_fullStr | 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 [version 2; peer review: 2 approved] |
| title_full_unstemmed | 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 [version 2; peer review: 2 approved] |
| title_short | 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 [version 2; peer review: 2 approved] |
| title_sort | 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 version 2 peer review 2 approved |
| topic | process evaluation intervention fidelity acceptability trial experience fractional factorial eng |
| url | https://openresearch.nihr.ac.uk/articles/3-3/v2 |
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