Identifying locally actionable strategies to increase participant acceptability and feasibility to participate in Phase I cancer clinical trials
Abstract Background Recruitment of cancer clinical trial (CCT) participants, especially participants representing the diversity of the US population, is necessary to create successful medications and a continual challenge. These challenges are amplified in Phase I cancer trials that focus on evaluat...
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-02-01
|
| Series: | Health Expectations |
| Subjects: | |
| Online Access: | https://doi.org/10.1111/hex.13920 |
| _version_ | 1797296143116271616 |
|---|---|
| author | Stephanie A. S. Staras Easton N. Wollney Lisa E. Emerson Natalie Silver Peter T. Dziegielewski Marta D. Hansen Gabriela Sanchez Dalila D'Ingeo Versie Johnson‐Mallard Rolf Renne Kristianna Fredenburg Michael Gutter Kendra Zamojski Carla Vandeweerd Carma L. Bylund |
| author_facet | Stephanie A. S. Staras Easton N. Wollney Lisa E. Emerson Natalie Silver Peter T. Dziegielewski Marta D. Hansen Gabriela Sanchez Dalila D'Ingeo Versie Johnson‐Mallard Rolf Renne Kristianna Fredenburg Michael Gutter Kendra Zamojski Carla Vandeweerd Carma L. Bylund |
| author_sort | Stephanie A. S. Staras |
| collection | DOAJ |
| description | Abstract Background Recruitment of cancer clinical trial (CCT) participants, especially participants representing the diversity of the US population, is necessary to create successful medications and a continual challenge. These challenges are amplified in Phase I cancer trials that focus on evaluating the safety of new treatments and are the gateway to treatment development. In preparation for recruitment to a Phase I recurrent head and neck cancer (HNC) trial, we assessed perceived barriers to participation or referral and suggestions for recruitment among people with HNC and community physicians (oncologist, otolaryngologist or surgeon). Methods Between December 2020 and February 2022, we conducted a qualitative needs assessment via semistructured interviews with a race and ethnicity‐stratified sample of people with HNC (n = 30: 12 non‐Hispanic White, 9 non‐Hispanic African American, 8 Hispanic and 1 non‐Hispanic Pacific Islander) and community physicians (n = 16) within the University of Florida Health Cancer Center catchment area. Interviews were analyzed using a qualitative content analysis approach to describe perspectives and identify relevant themes. Results People with HNC reported thematic barriers included: concerns about side effects, safety and efficacy; lack of knowledge and systemic and environmental obstacles. Physicians identified thematic barriers of limited physician knowledge; clinic and physician barriers and structural barriers. People with HNC and physicians recommended themes included: improved patient education, dissemination of trial information and interpersonal communication between community physicians and CCT staff. Conclusions The themes identified by people with HNC and community physicians are consistent with research efforts and recommendations on how to increase the participation of people from minoritized populations in CCTs. This community needs assessment provides direction on the selection of strategies to increase CCT participation and referral. Patient or Public Contribution This study focused on people with HNC and community physicians' lived experience and their interpretations of how they would consider a future Phase I clinical trial. In addition to our qualitative data reflecting community voices, a community member reviewed the draft interview guide before data collection and both people with HNC and physicians aided interpretation of the findings. |
| first_indexed | 2024-03-07T21:59:06Z |
| format | Article |
| id | doaj.art-70db8560562a4efd9138939a6f3b42a7 |
| institution | Directory Open Access Journal |
| issn | 1369-6513 1369-7625 |
| language | English |
| last_indexed | 2024-03-07T21:59:06Z |
| publishDate | 2024-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | Health Expectations |
| spelling | doaj.art-70db8560562a4efd9138939a6f3b42a72024-02-24T07:00:39ZengWileyHealth Expectations1369-65131369-76252024-02-01271n/an/a10.1111/hex.13920Identifying locally actionable strategies to increase participant acceptability and feasibility to participate in Phase I cancer clinical trialsStephanie A. S. Staras0Easton N. Wollney1Lisa E. Emerson2Natalie Silver3Peter T. Dziegielewski4Marta D. Hansen5Gabriela Sanchez6Dalila D'Ingeo7Versie Johnson‐Mallard8Rolf Renne9Kristianna Fredenburg10Michael Gutter11Kendra Zamojski12Carla Vandeweerd13Carma L. Bylund14Department of Health Outcomes and Biomedical Informatics University of Florida College of Medicine Gainesville Florida USADepartment of Health Outcomes and Biomedical Informatics University of Florida College of Medicine Gainesville Florida USADepartment of Microbiology and Cell Science, Institute of Food and Agricultural Sciences University of Florida Gainesville Florida USADepartment of Surgery Cleveland Clinic Cleveland Ohio USADepartment of Otolaryngology University of Florida College of Medicine Gainesville Florida USADepartment of Health Outcomes and Biomedical Informatics University of Florida College of Medicine Gainesville Florida USADepartment of Health Outcomes and Biomedical Informatics University of Florida College of Medicine Gainesville Florida USADepartment of Health Outcomes and Biomedical Informatics University of Florida College of Medicine Gainesville Florida USACenter for Nursing Research College of Nursing, Kent State Kent Ohio USADepartment of Molecular Genetics and Microbiology University of Florida College of Medicine Gainesville Florida USADepartment of Pathology University of Florida College of Medicine Gainesville Florida USADepartment of Family, Youth and Community Sciences, Institute of Food and Agricultural Sciences University of Florida Gainesville Florida USADepartment of Family, Youth and Community Sciences, Institute of Food and Agricultural Sciences University of Florida Gainesville Florida USADepartment of Health Outcomes and Biomedical Informatics University of Florida College of Medicine Gainesville Florida USADepartment of Health Outcomes and Biomedical Informatics University of Florida College of Medicine Gainesville Florida USAAbstract Background Recruitment of cancer clinical trial (CCT) participants, especially participants representing the diversity of the US population, is necessary to create successful medications and a continual challenge. These challenges are amplified in Phase I cancer trials that focus on evaluating the safety of new treatments and are the gateway to treatment development. In preparation for recruitment to a Phase I recurrent head and neck cancer (HNC) trial, we assessed perceived barriers to participation or referral and suggestions for recruitment among people with HNC and community physicians (oncologist, otolaryngologist or surgeon). Methods Between December 2020 and February 2022, we conducted a qualitative needs assessment via semistructured interviews with a race and ethnicity‐stratified sample of people with HNC (n = 30: 12 non‐Hispanic White, 9 non‐Hispanic African American, 8 Hispanic and 1 non‐Hispanic Pacific Islander) and community physicians (n = 16) within the University of Florida Health Cancer Center catchment area. Interviews were analyzed using a qualitative content analysis approach to describe perspectives and identify relevant themes. Results People with HNC reported thematic barriers included: concerns about side effects, safety and efficacy; lack of knowledge and systemic and environmental obstacles. Physicians identified thematic barriers of limited physician knowledge; clinic and physician barriers and structural barriers. People with HNC and physicians recommended themes included: improved patient education, dissemination of trial information and interpersonal communication between community physicians and CCT staff. Conclusions The themes identified by people with HNC and community physicians are consistent with research efforts and recommendations on how to increase the participation of people from minoritized populations in CCTs. This community needs assessment provides direction on the selection of strategies to increase CCT participation and referral. Patient or Public Contribution This study focused on people with HNC and community physicians' lived experience and their interpretations of how they would consider a future Phase I clinical trial. In addition to our qualitative data reflecting community voices, a community member reviewed the draft interview guide before data collection and both people with HNC and physicians aided interpretation of the findings.https://doi.org/10.1111/hex.13920cancercommunity oncologypatient educationPhase Iunderrepresentation |
| spellingShingle | Stephanie A. S. Staras Easton N. Wollney Lisa E. Emerson Natalie Silver Peter T. Dziegielewski Marta D. Hansen Gabriela Sanchez Dalila D'Ingeo Versie Johnson‐Mallard Rolf Renne Kristianna Fredenburg Michael Gutter Kendra Zamojski Carla Vandeweerd Carma L. Bylund Identifying locally actionable strategies to increase participant acceptability and feasibility to participate in Phase I cancer clinical trials Health Expectations cancer community oncology patient education Phase I underrepresentation |
| title | Identifying locally actionable strategies to increase participant acceptability and feasibility to participate in Phase I cancer clinical trials |
| title_full | Identifying locally actionable strategies to increase participant acceptability and feasibility to participate in Phase I cancer clinical trials |
| title_fullStr | Identifying locally actionable strategies to increase participant acceptability and feasibility to participate in Phase I cancer clinical trials |
| title_full_unstemmed | Identifying locally actionable strategies to increase participant acceptability and feasibility to participate in Phase I cancer clinical trials |
| title_short | Identifying locally actionable strategies to increase participant acceptability and feasibility to participate in Phase I cancer clinical trials |
| title_sort | identifying locally actionable strategies to increase participant acceptability and feasibility to participate in phase i cancer clinical trials |
| topic | cancer community oncology patient education Phase I underrepresentation |
| url | https://doi.org/10.1111/hex.13920 |
| work_keys_str_mv | AT stephanieasstaras identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT eastonnwollney identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT lisaeemerson identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT nataliesilver identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT petertdziegielewski identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT martadhansen identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT gabrielasanchez identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT daliladingeo identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT versiejohnsonmallard identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT rolfrenne identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT kristiannafredenburg identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT michaelgutter identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT kendrazamojski identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT carlavandeweerd identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials AT carmalbylund identifyinglocallyactionablestrategiestoincreaseparticipantacceptabilityandfeasibilitytoparticipateinphaseicancerclinicaltrials |