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Geriatric medicine
Protocol
Access to cancer clinical trials for racialised older adults: an equity-focused rapid scoping review protocol
  1. Vivian Li1,
  2. Shabbir M H Alibhai2,3,
  3. Kenneth Noel4,
  4. Rouhi Fazelzad5,
  5. Kristin Haase6,
  6. Caroline Mariano7,
  7. Sara Durbano2,
  8. Schroder Sattar8,
  9. Lorelei Newton9,
  10. David Dawe10,
  11. Jennifer A Bell11,
  12. Tina Hsu12,
  13. Sabrina T Wong13,
  14. Aisha Lofters14,
  15. Jacqueline L Bender15,16,
  16. Jackie Manthorne17,
  17. Martine T E Puts1
  1. 1Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada
  2. 2Department of Medicine, University Health Network, Toronto, Ontario, Canada
  3. 3Faculty of Medicine and Dalla Lana School of Public Health and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
  4. 4Walnut Foundation, Brampton, Ontario, Canada
  5. 5Library and Information Services, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada
  6. 6School of Nursing, University of British Columbia, Vancouver, British Columbia, Canada
  7. 7BC Cancer Agency Vancouver Centre, Vancouver, British Columbia, Canada
  8. 8College of Nursing, University of Saskatchewan, Saskatoon, Saskatchewan, Canada
  9. 9School of Nursing, University of Victoria, Victoria, British Columbia, Canada
  10. 10CancerCare Manitoba Research Institute, CancerCare Manitoba, Winnipeg, Manitoba, Canada
  11. 11Clinical and Organizational Ethics, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada
  12. 12Department of Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
  13. 13Division of Intramural Research, National Institute of Nursing Research, Bethesda, Maryland, USA
  14. 14Peter Gilgan Centre for Women’s Cancers, Women’s College Hospital, Toronto, Ontario, Canada
  15. 15Department of Supportive Care, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada
  16. 16Dalla Lana School of Public Health and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
  17. 17Canadian Cancer Survivor Network, Ottawa, Ontario, Canada
  1. Correspondence to Dr Martine T E Puts; martine.puts{at}utoronto.ca

Abstract

Background The intersection of race and older age compounds existing health disparities experienced by historically marginalised communities. Therefore, racialised older adults with cancer are more disadvantaged in their access to cancer clinical trials compared with age-matched counterparts. To determine what has already been published in this area, the rapid scoping review question are: what are the barriers, facilitators and potential solutions for enhancing access to cancer clinical trials among racialised older adults?

Methods We will use a rapid scoping review methodology in which we follow the six-step framework of Arksey and O’Malley, including a systematic search of the literature with abstract and full-text screening to be conducted by two independent reviewers, data abstraction by one reviewer and verification by a second reviewer using an Excel data abstraction sheet. Articles focusing on persons aged 18 and over who identify as a racialised person with cancer, that describe therapies/therapeutic interventions/prevention/outcomes related to barriers, facilitators and solutions to enhancing access to and equity in cancer clinical trials will be eligible for inclusion in this rapid scoping review.

Ethics and dissemination All data will be extracted from published literature. Hence, ethical approval and patient informed consent are not required. The findings of the scoping review will be submitted for publication in a peer-reviewed journal and presentation at international conferences.

  • Health Equity
  • ONCOLOGY
  • GERIATRIC MEDICINE
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi-org.ezproxy.u-pec.fr/10.1136/bmjopen-2023-074191

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    STRENGTHS AND LIMITATIONS OF THIS STUDY

    • First systematic review focusing on barriers and facilitators for racialised older adults accessing clinical trials for any type of cancer from around the world.

    • Uses the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and the PRISMA-Equity.

    • Literature search is comprehensive and includes the Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Ovid Embase Classic+Embase, CINAHL from EBSCOhost, Scopus from Elsevier and Global Index Medicus from WHO databases.

    • Involved extensive consultation with patient partners throughout the review process.

    • Risk of bias in the included studies due to the rapid time frame compared with a conventional review where a quality assessment of the included studies would be conducted.

    Background

    Racialised older adults with cancer are more likely to be disadvantaged in their access to cancer clinical trials. Older adults, here defined as those aged 65 and over, comprise the majority of those diagnosed with cancer. Currently, 30% of the Canadian population aged 65+ is foreign-born and this is estimated to increase to 40% by 2055.1 Both age and race can affect access to clinical trials and the intersection of these two dimensions may compound challenges faced by older adults who also identify as a racialised person.2 The protocol and rapid scoping review use the term ‘racialised’ as recommended by the Ontario Human Rights Commission.3 4 The terms ‘racialised person’ or ‘racialised group’ are broad, general terms as opposed to ‘racial minority’, ‘visible minority’, ‘person of colour’ or ‘non-white’.3 4 The term, ‘racialised’, is preferred because race is a social construct imposed on individuals rather than an objective, scientifically recognised biological distinction.3 4 However, a preferred term may vary among countries depending on the makeup of the population. For the purposes of the protocol and rapid scoping review, racialised persons include ‘immigrant’, ‘minority’ and ‘vulnerable persons’.

    In the USA, racialised older adults are under-represented in cancer clinical trials leading to U.S. Food and Drug Administration (FDA) approval as recently as 2019.5–21 Various reasons related to the patient, clinician and/or trial structure contribute to under enrolment of racialised older adults.11 Improved enrolment of racialised older adults is considered a key requirement for improving cancer treatment outcomes for this patient group.11 22–25 Due to the lack of clinical trial evidence about racialised and frail older adults as a combined study group, older adults are both undertreated and overtreated, leading to potential harm to the patient due to treatment toxicity and suboptimal cancer treatment outcomes and resource use.26–46 However, there is a lack of equivalent data in Canada about racialised older adults’ access to cancer clinical trials. Braveman describes the need to measure health disparities as a metric of progress towards health equity in Canada,47 48 particularly clinical trial data by age and race as it may impact cancer treatment efficacy and outcomes and lend insight into disparities. Data on age and race in cancer clinical trials is rarely collected,49 leading to an important gap in evidence.

    Social determinants of health (SDOH), such as income, are non-medical factors that influence health outcomes. According to the WHO, SDOH influence health equity and can account for up to 30%–55% of variation in health outcomes.50 In the USA, Black Americans are more likely to be diagnosed with advanced cancer and are more likely to die of cancer compared with their white counterparts.6 7 9–14 21 25 51–80 These health disparities are the result of SDOH, such as financial barriers to cancer screening, inequitable access to cancer diagnosis and cancer treatment, and mistrust of the healthcare system.6 7 9–14 21 25 51–80 Late stage at diagnosis is the largest contributor to racial differences in cancer survival.11 55 57 61 70 76 79–82 Equivalent data are not available for Canadian comparisons or to inform policy. However, many studies of health disparities in cancer screening in Canada show that new immigrants have significantly lower cancer screening rates, which contributes to disparities in cancer treatment outcomes.83–95 Groups such as Indigenous people and recent immigrants have more than one risk factor related to SDOH, increasing their likelihood of poorer health outcomes.96 The intersection of racism and ageism further exacerbates these existing disparities in SDOH, leading to even poorer health outcomes.97

    There is an important research and knowledge gap in the literature as past reviews of racialised older adults’ access to cancer clinical trials have several limitations. Past reviews have not discussed clinical trial recruitment in detail specific to racialised and older adults as a combined group.98 99 This is important to understand and address the barriers and facilitators with collecting data on race in a clinical trial context. Although the harmful impacts of racism on healthcare and research have been well documented in the literature, research on the intersection of racism and ageism is limited.97 Past reviews have also been narrative in nature and not included systematic searches, introducing a high likelihood of bias by omitting potential studies about and incompletely summarising access to cancer clinical trials for racialised older adults.100 101 For example, a narrative scoping literature review by Arring et al aimed to identify, describe and categorise strategies and interventions to improve the recruitment and retention of black participants in cancer clinical trials for four types of cancer conducted in the USA only.101 Furthermore, past reviews, including the review by Arring et al, have been limited to US-based studies only.101–103 Therefore, it is necessary to summarise any existing literature and identify gaps in the broader literature about racialised older adults’ access to cancer clinical trials in order to understand and improve continued health disparities contributing to poorer health outcomes for racialised older adults compared with their age-matched counterparts.

    Therefore, the rapid scoping review question is: what are the barriers, facilitators and potential solutions for enhancing access to cancer clinical trials among racialised older adults? Our rapid scoping review will follow similar aims as the review by Arring et al,101 but for racialised older adults and including any type of cancer in any country. Findings of this review will provide an overview of the current state of racialised older adults’ experiences with cancer clinical trials. These findings will inform potential solutions to reduce health disparities based on age and race in order to promote age-sensitive health equity approaches in cancer clinical trials.

    Materials and methods

    The rapid scoping review methods will be guided by the WHO’s guide to rapid reviews.104–106 Compared with a conventional scoping review, we will use streamlined methods tailored to the needs of key stakeholders representing racialised groups. For the literature search, we will use strategies such as limiting by language to only studies written in English.104–106 An integrated knowledge translation approach will be used to engage with key stakeholders throughout the review process, including during research question development, the literature search, study inclusion and exclusion, interpretating results and drafting the report.

    We will also apply Arksey and O’Malley’s methodological framework for scoping reviews advanced by Levac et al.107 This framework consists of six stages: (1) identifying the research questions, (2) identifying relevant studies, (3) study selection, (4) data charting, (5) collating, summarising and reporting results and (6) expert consultation.102 The reporting of the rapid scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) as well as the PRISMA-Equity extension (online supplemental files 1 and 2). See online supplemental file 3 for the study timeline.

    Identifying the research questions

    The rapid scoping review will answer the research question: what are the barriers, facilitators and potential solutions for enhancing access to cancer clinical trials among racialised older adults?

    Identifying relevant studies

    A comprehensive search will be developed by an information specialist (RF) in collaboration with individuals with clinical and research expertise relevant to racialised older adults and cancer clinical trials in Medline ALL (MEDLINE and MEDLINE Epub Ahead of Print and In-Process & Other Non-Indexed Citations) from the OvidSP platform (online supplemental files 4–10). The search was conducted on 23 November 2022, and limited to human studies, publications in English and study populations with adults aged 18 and over. Though older adults were defined as those aged 65+, our search will include studies with persons aged 18+ to ensure that all older adult study populations are captured as individual studies’ definitions of older adults may vary. There will be no limits placed on the racial identities of study populations, the cancer types within study populations, the types of study designs (quantitative or qualitative) and the countries in which studies are conducted in order to facilitate a comprehensive search. A combination of controlled vocabulary terms and text words were used in the subject block structure (cancer). Alternative terms were included in one block (racial/ethnicity/minority/immigrants), related synonyms were contained in a second block (clinical research/patient participation/patient selection) and relevant synonymous terms were contained in a third block. The specific search strategy was translated to the following databases and adapted to each database-specific search syntax and available limits from the databases’ inception to the date of the search: Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Ovid Embase Classic+Embase, CINAHL from EBSCOhost, Scopus from Elsevier and Global Index Medicus from WHO.

    The following concepts were developed to form the search strategy:

    1. Racialised older adults.

    2. Cancer clinical trial and recruitment and retention strategies.

    Collectively, the search strategy was used to search databases to identify primary research articles and scoping or systematic reviews. As the broad parameters of this search strategy will comprehensively capture any literature related to the above concepts, grey literature will not be included. We will also search the reference lists of included primary research articles and scoping or systematic reviews to identify any additional relevant articles.

    Study selection

    Studies retrieved using the above search strategy were imported into EndNote V.X8.2 for reference management and Covidence for study deduplication. All studies will be screened by two independent reviewers according to the above inclusion and exclusion criteria listed in table 1.

    View this table:
    Table 1

    Study inclusion and exclusion criteria

    At the full-text screening conducted by two independent reviewers, scoping or systematic reviews that meet the inclusion criteria will be further assessed by retrieving the primary research articles included in these reviews. Only primary research articles that meet the inclusion criteria will be included in the rapid scoping review. If two articles reporting on the same study are identified, they will be included as one study. Disagreement between the reviewers will be resolved by consulting a third reviewer. The study selection process will be presented using the PRISMA-ScR flow chart.

    Data charting

    One reviewer will complete the charting table for each study (table 2). The data abstraction will be independently reviewed by a second reviewer. Discrepancies in data charting will be resolved by consulting a third reviewer. If any data items are not noted in the retrieved studies, it will be recorded as ‘not reported’.

    View this table:
    Table 2

    Data charting table

    Collating, summarising and reporting results

    Data abstracted will include the study information (year of publication, country of study, type of article, study design and objectives), study population information (age, sex/gender, race and type of cancer) and information on the barriers, facilitators, potential solutions and gaps in the research (table 2).

    Expert consultation

    We will engage stakeholders representing racialised groups to inform the study design and provide feedback on these findings (online supplemental file 11). Other stakeholders for the rapid scoping review include racialised older adults, primary cancer care providers, oncologists, nurses, clinical researchers and policy-makers. We will seek feedback from these stakeholders throughout preparing this review protocol, at the time of our literature search, at the time of initial study title and abstract screening, and prior to review of the study full texts. After summarising the results of the included studies but before finalising the review manuscript, we will also share these with our stakeholders for any further insights. To do so, we will host virtual meetings with our stakeholders at each of the aforementioned study checkpoints, which will be facilitated by the research team. A final virtual stakeholder meeting will be organised to discuss next steps in reducing the factors contributing to health disparities in cancer clinical trials as reported in the review results. No descriptive data from the participants of this workshop will be collected.

    Patient and public involvement

    Two team members are president/CEO of patient advocacy organisations and are involved in the study design, conduct and data analysis. We will conduct a stakeholder consultation with different organisations involved in caring for racialised older adults (online supplemental file 11) to discuss findings and next steps. These organisations were identified using snowball sampling techniques, contacts of the investigator team (including prior collaborators or members of existing networks and included community organisations/agencies/foundations that focus on healthcare and targeted at least one of the racialised communities of interest. These stakeholders have been involved in setting the review question and will be involved in the interpretation of the results and recommendations for clinical practice and research.

    Ethics and dissemination

    Ethics approval is not required for this review. We will publish the rapid scoping review in a peer-reviewed journal and present findings to stakeholders. No data will be collected from stakeholders.

    Ethics statements

    Patient consent for publication

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    Footnotes

    • Twitter @benderjack, @martine_puts

    • Contributors Conceptualisation: VL, SMHA, KN, RF, KH, CM, SD, SS, LN, DD, JAB, TH, STW, AL, JLB, JM and MTEP. Funding acquisition: SMHA, MTEP and KN. Methodology: VL, SMHA, KN, RF, KH, CM, SD, SS, LN, DD, JAB, TH, STW, AL, JLB, JM and MTEP. Supervision: SMHA and MTEP. Writing–original draft: VL. Writing–review and editing: VL, SMHA, KN, RF, KH, CM, SD, SS, LN, DD, JAB, TH, STW, AL, JLB, JM and MTEP. Final approval of the version to be published: VL, SMHA, KN, RF, KH, CM, SD, SS, LN, DD, JAB, TH, STW, AL, JLB, JM and MTEP. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: VL, SMHA, KN, RF, KH, CM, SD, SS, LN, DD, JAB, TH, STW, AL, STW, JM and MTEP.

    • Funding This study is funded by the Princess Margaret Health Equity Grand Challenge, supported by the generosity of Lindy Green & Sam Chaiton. MTEP is supported by a Canada Research Chair in the care for frail older adults.

    • Disclaimer The funder did not and will not have a role in study design, data collection and analysis, or preparation of reports.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.