Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial
Objectives Bench to bedside translation of groundbreaking treatments like chimeric antigen receptor T (CAR-T) cell therapy depends on patient participation in early phase trials. Unfortunately, many novel therapies fail to be adequately evaluated due to low recruitment rates, which slows patient acc...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2021-03-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/3/e043929.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846161930554703872 |
|---|---|
| author | Dean A Fergusson Manoj M Lalu Justin Presseau Kednapa Thavorn Joshua Montroy Natasha Kekre Gisell Castillo Sarah Asad Madison Foster Terry Hawrysh Harold Atkins Stuart Schwartz Robert A Holt Raewyn Broady |
| author_facet | Dean A Fergusson Manoj M Lalu Justin Presseau Kednapa Thavorn Joshua Montroy Natasha Kekre Gisell Castillo Sarah Asad Madison Foster Terry Hawrysh Harold Atkins Stuart Schwartz Robert A Holt Raewyn Broady |
| author_sort | Dean A Fergusson |
| collection | DOAJ |
| description | Objectives Bench to bedside translation of groundbreaking treatments like chimeric antigen receptor T (CAR-T) cell therapy depends on patient participation in early phase trials. Unfortunately, many novel therapies fail to be adequately evaluated due to low recruitment rates, which slows patient access to emerging treatments. Using the Theoretical Domains Framework (TDF), we sought to identify potential patient barriers and enablers to participating in an early phase CAR-T cell therapy trial.Design We used qualitative semistructured interviews to identify potential barriers and enablers to patients’ hypothetical participation in an early phase CAR-T cell therapy trial. We used the TDF and directed content analysis to identify relevant domains based on frequency, relevance and the presence of conflicting beliefs.Participants Canadian adult patients diagnosed with haematological malignancies.Results In total, we interviewed 13 participants (8 women, 5 men). Participants ranged in age from 18 to 73 (median=56) and had been living with haematological cancer from a few months to several years. We found participants were unfamiliar with CAR-T cell therapy but wished to know more about treatment safety, efficacy and trial logistics (domains: knowledge, beliefs about consequences). They were motivated by altruistic considerations, though many prioritised personal health benefits despite recognising the goals (ie, establishing safety) of early phase clinical trials (domains: goals, intentions). Every participant valued receiving medical advice from their haematologists and oncologists, though some preferred impartial medical experts to inform their decision making (domain: social influences). Finally, participants indicated that improving access to financial and social supports would improve their trial participation experience (domain: environmental context and resources).Conclusion Using the TDF allowed us to identify factors that might undermine participation to a CAR-T cell therapy trial and to optimise recruitment processes by considering patient perspectives to taking part in early phase trials.Trial regestration: NCT03765177; Pre-results. |
| format | Article |
| id | doaj-art-e15ae9c463df487f90a74d002eadfad4 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-e15ae9c463df487f90a74d002eadfad42024-11-21T01:10:06ZengBMJ Publishing GroupBMJ Open2044-60552021-03-0111310.1136/bmjopen-2020-043929Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trialDean A Fergusson0Manoj M Lalu1Justin Presseau2Kednapa Thavorn3Joshua Montroy4Natasha Kekre5Gisell Castillo6Sarah Asad7Madison Foster8Terry Hawrysh9Harold Atkins10Stuart Schwartz11Robert A Holt12Raewyn Broady13Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, CanadaClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaSchool of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, CanadaSchool of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, CanadaBlueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaBlueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaBlueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaBlueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaPatient Partner, Toronto, Ontario, CanadaDepartment of Medicine, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaPatient partner, Ottawa, Ontario, CanadaGenome Sciences Centre, BC Cancer, Vancouver, British Columbia, CanadaLeukemia/BMT Program, Vancouver General Hospital, Vancouver, British Columbia, CanadaObjectives Bench to bedside translation of groundbreaking treatments like chimeric antigen receptor T (CAR-T) cell therapy depends on patient participation in early phase trials. Unfortunately, many novel therapies fail to be adequately evaluated due to low recruitment rates, which slows patient access to emerging treatments. Using the Theoretical Domains Framework (TDF), we sought to identify potential patient barriers and enablers to participating in an early phase CAR-T cell therapy trial.Design We used qualitative semistructured interviews to identify potential barriers and enablers to patients’ hypothetical participation in an early phase CAR-T cell therapy trial. We used the TDF and directed content analysis to identify relevant domains based on frequency, relevance and the presence of conflicting beliefs.Participants Canadian adult patients diagnosed with haematological malignancies.Results In total, we interviewed 13 participants (8 women, 5 men). Participants ranged in age from 18 to 73 (median=56) and had been living with haematological cancer from a few months to several years. We found participants were unfamiliar with CAR-T cell therapy but wished to know more about treatment safety, efficacy and trial logistics (domains: knowledge, beliefs about consequences). They were motivated by altruistic considerations, though many prioritised personal health benefits despite recognising the goals (ie, establishing safety) of early phase clinical trials (domains: goals, intentions). Every participant valued receiving medical advice from their haematologists and oncologists, though some preferred impartial medical experts to inform their decision making (domain: social influences). Finally, participants indicated that improving access to financial and social supports would improve their trial participation experience (domain: environmental context and resources).Conclusion Using the TDF allowed us to identify factors that might undermine participation to a CAR-T cell therapy trial and to optimise recruitment processes by considering patient perspectives to taking part in early phase trials.Trial regestration: NCT03765177; Pre-results.https://bmjopen.bmj.com/content/11/3/e043929.full |
| spellingShingle | Dean A Fergusson Manoj M Lalu Justin Presseau Kednapa Thavorn Joshua Montroy Natasha Kekre Gisell Castillo Sarah Asad Madison Foster Terry Hawrysh Harold Atkins Stuart Schwartz Robert A Holt Raewyn Broady Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial BMJ Open |
| title | Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial |
| title_full | Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial |
| title_fullStr | Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial |
| title_full_unstemmed | Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial |
| title_short | Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial |
| title_sort | navigating choice in the face of uncertainty using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor t car t cell therapy trial |
| url | https://bmjopen.bmj.com/content/11/3/e043929.full |
| work_keys_str_mv | AT deanafergusson navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT manojmlalu navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT justinpresseau navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT kednapathavorn navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT joshuamontroy navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT natashakekre navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT gisellcastillo navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT sarahasad navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT madisonfoster navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT terryhawrysh navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT haroldatkins navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT stuartschwartz navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT robertaholt navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial AT raewynbroady navigatingchoiceinthefaceofuncertaintyusingatheoryinformedqualitativeapproachtoidentifyingpotentialpatientbarriersandenablerstoparticipatinginanearlyphasechimericantigenreceptortcartcelltherapytrial |