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Barriers to clinical trial enrollment of older adults with cancer: A qualitative study of the perceptions of community and academic oncologists

      Abstract

      Objectives

      Oncologists can be one of the major barriers to older adult's participation in research. Multiple studies have described academic clinicians' concerns for not enrolling older adults onto trials. Although the majority of older adults receive their cancer care in the community, few studies have examined the unique challenges that community oncologists face and how they differ from oncologist-related barriers in academia.

      Methods

      Semi-structured interviews were conducted by telephone or face-to-face with 44 medical oncologists (24 academic-based and 20 community-based) at City of Hope from March to June 2018. Interviews explored oncologists' perceptions of barriers to clinical trial enrollment of older adults with cancer. Data were analyzed using qualitative content analysis.

      Results

      Of the 44 participants, 36% were women and 68% were in practice for >10 years. Among the entire sample, stringent eligibility criteria (n = 20) and oncologist concerns for treatment toxicities (n = 15) were the most commonly cited barriers. Compared to academic oncologists, community oncologists more often cited patient attitudes, beliefs, and understanding (n = 9 vs. n = 2) and caregiver burden (n = 6 vs. n = 0). In contrast, compared to community oncologists, academic oncologists more often cited oncologist bias (n = 10 vs. n = 3) and insufficient time/support (n = 4 vs. n = 1).

      Conclusions

      Differences in perceptions among academic and community oncologists about trials suggest that barriers are multifaceted, complex, and vary by practice setting. Interventions to increase trial accrual among older adults with cancer may benefit from being tailored to address the unique barriers of different practice settings.
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      References

        • Singh H.
        • Kanapuru B.
        • Smith C.
        • et al.
        FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: a 10-year experience by the U.S. Food and Drug Administration.
        J Clin Oncol. 2017; 35 (10009–10009)
        • Hurria A.
        • Dale W.
        • Mooney M.
        • et al.
        Designing therapeutic clinical trials for older and frail adults with Cancer: U13 conference recommendations.
        J Clin Oncol. 2014; 32: 2587-2594
        • Hurria A.
        • Levit L.A.
        • Dale W.
        • et al.
        Improving the evidence base for treating older adults with Cancer: american Society of Clinical Oncology statement.
        J Clin Oncol. 2015; 33: 3826-3833
        • Hurria A.
        • Naylor M.
        • Cohen H.J.
        Improving the quality of cancer care in an aging population: recommendations from an IOM report.
        Jama. 2013; 310: 1795-1796
        • Kim E.S.
        • Bruinooge S.S.
        • Roberts S.
        • et al.
        Broadening eligibility criteria to make clinical trials more representative: american Society of Clinical Oncology and friends of Cancer research joint research statement.
        J Clin Oncol. 2017; 35: 3737-3744
        • Lichtman S.M.
        • Harvey R.D.
        • Damiette Smit M.A.
        • et al.
        Modernizing clinical trial eligibility criteria: recommendations of the American Society of Clinical Oncology-friends of Cancer research organ dysfunction, prior or concurrent malignancy, and comorbidities working group.
        J Clin Oncol. 2017; 35: 3753-3759
        • Mohile S.G.
        • Hurria A.
        • Cohen H.J.
        • et al.
        Improving the quality of survivorship for older adults with cancer.
        Cancer. 2016; 122: 2459-2568
        • Kimmick G.
        • Correspondence A.
        • Kimmick G.
        Duke Cancer institute DUMCB, states DU. Clinical trial accrual in older cancer patients: the most important steps are the first ones.
        J Geriatric Oncol. 2016; 7: 158-161
        • Townsley C.A.
        • Selby R.
        • Siu L.L.
        Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials.
        J Clin Oncol. 2005; 23: 3112-3124
        • Hurria A.
        Clinical trials in older adults with cancer: past and future.
        . 2007; 21 ([discussion 363]): 351-358
        • Baggstrom M.Q.
        • Waqar S.N.
        • Sezhiyan A.K.
        • et al.
        Barriers to enrollment in non-small cell lung cancer therapeutic clinical trials.
        J Thorac Oncol. 2011; 6: 98-102
        • Kaas R.
        • Hart A.A.
        • Rutgers E.J.
        The impact of the physician on the accrual to randomized clinical trials in patients with primary operable breast cancer.
        . 2005; 14: 310-316
        • Martel C.L.
        • Li Y.
        • Beckett L.
        • et al.
        An evaluation of barriers to accrual in the era of legislation requiring insurance coverage of cancer clinical trial costs in California.
        Cancer J. 2004; 10: 294-300
        • Unger J.M.
        • Cook E.
        • Tai E.
        • Bleyer A.
        The role of clinical trial participation in Cancer research: barriers, evidence, and strategies.
        Am Soc Clin Oncol Educ Book. 2016; 35: 185-198
        • Kornblith A.B.
        • Kemeny M.
        • Peterson B.L.
        • et al.
        Survey of oncologists' perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials.
        Cancer. 2002; 95: 989-996
        • Kemeny M.M.
        • Peterson B.L.
        • Kornblith A.B.
        • et al.
        Barriers to clinical trial participation by older women with breast cancer.
        J Clin Oncol. 2003; 21: 2268-2275
        • Javid S.H.
        • Unger J.M.
        • Gralow J.R.
        • et al.
        A prospective analysis of the influence of older age on physician and patient decision-making when considering enrollment in breast Cancer clinical trials (SWOG S0316).
        Oncologist. 2012; 17: 1180-1190
        • Hamaker M.E.
        • Seynaeve C.
        • Nortier J.W.
        • et al.
        Slow accrual of elderly patients with metastatic breast cancer in the Dutch multicentre OMEGA study.
        Breast. 2013; 22: 556-559
        • Freedman R.A.
        • Dockter T.J.
        • Lafky J.M.
        • et al.
        Promoting accrual of older patients with Cancer to clinical trials: an Alliance for clinical trials in oncology member survey (A171602).
        Oncologist. 2018; 23: 1016-1023
        • Moore D.H.
        • Kauderer J.T.
        • Bell J.
        • Curtin J.P.
        • Van Le L.
        An assessment of age and other factors influencing protocol versus alternative treatments for patients with epithelial ovarian cancer referred to member institutions: a gynecologic oncology group study.
        Gynecol Oncol. 2004; 94: 368-374
        • McCleary N.J.
        • Hubbard J.
        • Mahoney M.R.
        • et al.
        Challenges of conducting a prospective clinical trial for older patients: lessons learned from NCCTG N0949 (alliance).
        J Geriatric Oncol. 2018; 9: 24-31
        • Yee K.W.
        • Pater J.L.
        • Pho L.
        • Zee B.
        • Siu L.L.
        Enrollment of older patients in cancer treatment trials in Canada: why is age a barrier?.
        J Clin Oncol. 2003; 21: 1618-1623
        • Kimmick G.G.
        • Peterson B.L.
        • Kornblith A.B.
        • et al.
        Improving accrual of older persons to cancer treatment trials: a randomized trial comparing an educational intervention with standard information: CALGB 360001.
        J Clin Oncol. 2005; 23: 2201-2207
        • Crome P.
        • Lally F.
        • Cherubini A.
        • et al.
        Exclusion of older people from clinical trials: professional views from nine European countries participating in the PREDICT study.
        Drugs Aging. 2011; 28: 667-677
        • Nabhan C.
        • Jeune-Smith Y.
        • Klinefelter P.
        • Kelly R.J.
        • Feinberg B.A.
        Challenges, perceptions, and readiness of oncology clinicians for the MACRA quality payment program.
        JAMA Oncol. 2018; 4: 252-253
        • Desch C.E.
        • Blayney D.W.
        Making the choice between academic oncology and community practice: the big picture and details about each career.
        J Oncol Pract. 2006; 2: 132-136
        • Shanafelt T.D.
        • Gradishar W.J.
        • Kosty M.
        • et al.
        Burnout and career satisfaction among US oncologists.
        J Clin Oncol. 2014; 32: 678-686
        • Tsang J.L.Y.
        • Ross K.
        It's time to increase community hospital-based health research.
        Acad Med. 2017; 92: 727
        • Carey M.
        • Boyes A.W.
        • Smits R.
        • Bryant J.
        • Waller A.
        • Olver I.
        Access to clinical trials among oncology patients: results of a cross sectional survey.
        BMC Cancer. 2017; 17 (653–653)
        • Likumahuwa S.
        • Song H.
        • Singal R.
        • et al.
        Building research infrastructure in community health centers: a community health applied research network (CHARN) report.
        J Am Board Fam Med. 2013; 26: 579-587
        • Bellera C.
        • Praud D.
        • Petit-Moneger A.
        • McKelvie-Sebileau P.
        • Soubeyran P.
        • Mathoulin-Pelissier S.
        Barriers to inclusion of older adults in randomised controlled clinical trials on non-Hodgkin's lymphoma: a systematic review.
        Cancer Treat Rev. 2013; 39: 812-817
        • Denson A.C.
        • Mahipal A.
        Participation of the elderly population in clinical trials: barriers and solutions.
        Cancer Control. 2014; 21: 209-214
        • Ford J.G.
        • Howerton M.W.
        • Bolen S.
        • et al.
        Knowledge and access to information on recruitment of underrepresented populations to cancer clinical trials.
        Evid Rep Technol Assess (Summ). 2005; 122: 1-11
        • Ford J.G.
        • Howerton M.W.
        • Lai G.Y.
        • et al.
        Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review.
        Cancer. 2008; 112: 228-242
        • Gouverneur A.
        • Salvo F.
        • Berdai D.
        • et al.
        Inclusion of elderly or frail patients in randomized controlled trials of targeted therapies for the treatment of metastatic colorectal cancer: a systematic review.
        J Geriatric Oncol. 2018; 9: 15-23
        • Kazmierska J.
        • Correspondence A.
        • Kazmierska J.
        Radiotherapy department ii GPCC, Garbary St PPEjkwp. Do we protect or discriminate? representation of senior adults in clinical trials.
        Rep Pract Oncol Radiother. 2013; 18: 6-10
        • Moore D.H.
        • Kauderer J.T.
        • Bell J.
        • Curtin J.P.
        • Van Le L.
        An assessment of age and other factors influencing protocol versus alternative treatments for patients with epithelial ovarian cancer referred to member institutions: a gynecologic oncology group study.
        Gynecol Oncol. 2004; 94: 368-374
        • Puts M.T.E.
        • Monette J.
        • Girre V.
        • et al.
        Participation of older newly-diagnosed cancer patients in an observational prospective pilot study: an example of recruitment and retention.
        BMC Cancer. 2009; 9 (277–277)
        • Javid S.H.
        • Unger J.M.
        • Gralow J.R.
        • et al.
        A prospective analysis of the influence of older age on physician and patient decision-making when considering enrollment in breast cancer clinical trials (SWOG S0316).
        . 2012; 17: 1180-1190
        • Hamaker M.
        • Seynaeve C.
        • Nortier J.
        • et al.
        Slow accrual of elderly patients with metastatic breast cancer in the Dutch multicentre OMEGA study.
        . 2013; 22: 556-559
        • Townsley C.A.
        • Chan K.K.
        • Pond G.R.
        • Marquez C.
        • Siu L.L.
        • Straus S.E.
        Understanding the attitudes of the elderly towards enrolment into cancer clinical trials.
        BMC Cancer. 2006; 6: 34
        • Ayodele O.
        • Akhtar M.
        • Konenko A.
        • et al.
        Comparing attitudes of younger and older patients towards cancer clinical trials.
        J Geriatric Oncol. 2016; 7: 162-168
        • Basche M.
        • Baron A.E.
        • Eckhardt S.G.
        • et al.
        Barriers to enrollment of elderly adults in early-phase cancer clinical trials.
        J Oncol Pract. 2008; 4: 162-168
        • Prieske K.
        • Trillsch F.
        • Oskay-Ozcelik G.
        • et al.
        Participation of elderly gynecological cancer patients in clinical trials.
        Arch Gynecol Obstet. 2018; 298: 797-804
        • Freedman R.A.
        • Tolaney S.M.
        Efficacy and safety in older patient subsets in studies of endocrine monotherapy versus combination therapy in patients with HR+/HER2- advanced breast cancer: a review.
        Breast Cancer Res Treat. 2018; 167: 607-614
        • Elo S.
        • Kyngäs H.
        The qualitative content analysis process.
        J Adv Nurs. 2008; 62: 107-115
        • Vaismoradi M.
        • Turunen H.
        • Bondas T.
        Content analysis and thematic analysis: implications for conducting a qualitative descriptive study.
        Nurs Health Sci. 2013; 15: 398-405
        • Bengtsson M.
        How to plan and perform a qualitative study using content analysis.
        Nurs Plus Open. 2016; 2: 8-14
        • MacPhail C.
        • Khoza N.
        • Abler L.
        • Ranganathan M.
        Process guidelines for establishing Intercoder reliability in qualitative studies.
        Qualitat Res. 2015; 16: 198-212
        • Ritchie J.
        • Lewis J.
        • Nicholls C.M.
        • Ormston R.
        Qualitative research practice: a guide for social science students and researchers.
        Sage, 2013
        • Tong A.
        • Sainsbury P.
        • Craig J.
        Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.
        International J Qual Health Care. 2007; 19: 349-357
        • Levit L.A.
        • Singh H.
        • Klepin H.D.
        • Hurria A.
        Expanding the evidence base in geriatric oncology: action items from an FDA-ASCO workshop.
        J Natl Cancer Inst. 2018; 110: 1163-1170
        • Bernard M.A.
        • Clayton J.A.
        • Lauer M.S.
        Inclusion across the lifespan: NIH policy for clinical ResearchNIH policy for inclusion across the lifespan in clinical ResearchNIH policy for inclusion across the lifespan in clinical research.
        Jama. 2018; 320: 1535-1536
        • Kim E.S.
        • Bruinooge S.S.
        • Roberts S.
        • et al.
        Broadening eligibility criteria to make clinical trials more representative: american society of clinical oncology and friends of cancer research joint research statement.
        J Clin Oncol. 2017; 35: 3737-3744
        • Gurrea Arroyo J.
        • Bollain I.G.
        • Esquiu C.P.
        Multidisciplinary treatment plans in the adult patient - step by step and rationale.
        Eur J Esthetic Dentist. 2012; 7: 18-35
        • Rouge-Bugat M.E.
        • Gerard S.
        • Balardy L.
        • et al.
        Impact of an oncogeriatric consulting team on therapeutic decision-making.
        J Nutr Health Aging. 2013; 17: 473-478
        • Horgan A.M.
        • Leighl N.B.
        • Coate L.
        • et al.
        Impact and feasibility of a comprehensive geriatric assessment in the oncology setting: a pilot study.
        Am J Clin Oncol. 2012; 35: 322-328
        • Caillet P.
        • Canoui-Poitrine F.
        • Vouriot J.
        • et al.
        Comprehensive geriatric assessment in the decision-making process in elderly patients with cancer: ELCAPA study.
        J Clin Oncol. 2011; 29: 3636-3642
        • Schulkes K.J.
        • Souwer E.T.
        • Hamaker M.E.
        • et al.
        The effect of a geriatric assessment on treatment decisions for patients with lung Cancer.
        Lung. 2017; 195: 225-231
        • Chaibi P.
        • Magne N.
        • Breton S.
        • et al.
        Influence of geriatric consultation with comprehensive geriatric assessment on final therapeutic decision in elderly cancer patients.
        Crit Rev Oncol Hematol. 2011; 79: 302-307
        • Huillard O.
        • Boudou-Rouquette P.
        • Chahwakilian A.
        • et al.
        Multidisciplinary risk assessment to reveal cancer treatments in complex cancer patients.
        J Clin Oncol. 2014; 32 (170–170)
        • Mertens C.
        • Le Caer H.
        • Ortholan C.
        • et al.
        1050PDThe ELAN-ONCOVAL (ELderly heAd and Neck cancer-Oncology eValuation) study: Evaluation of the feasibility of a suited geriatric assessment for use by oncologists to classify patients as fit or unfit.
        Ann Oncol. 2017; 28 (mdx374.007-mdx374.007)
        • Boulahssass R.
        • Gonfrier S.
        • Isabelle B.
        • et al.
        Influence of the comprehensive geriatric assessment (CGA) in elderly metastatic cancer patients. Analysis from a prospective cohort of 1048 patients.
        J Clin Oncol. 2016; 34 (10045–10045)
        • Girre V.
        • Falcou M.C.
        • Gisselbrecht M.
        • et al.
        Does a geriatric oncology consultation modify the cancer treatment plan for elderly patients? the journals of gerontology Series A.
        Biol Sci Med Sci. 2008; 63: 724-730
        • Aliamus V.
        • Adam C.
        • Druet-Cabanac M.
        • Dantoine T.
        • Vergnenegre A.
        Geriatric assessment contribution to treatment decision-making in thoracic oncology.
        Rev Mal Respir. 2011; 28: 1124-1130
        • Extermann M.
        • Boler I.
        • Reich R.R.
        • et al.
        Predicting the risk of chemotherapy toxicity in older patients: the chemotherapy risk assessment scale for high-age patients (CRASH) score.
        Cancer. 2012; 118: 3377-3386
        • Townsley C.A.
        • Chan K.K.
        • Pond G.R.
        • Marquez C.
        • Siu L.L.
        • Straus S.E.
        Understanding the attitudes of the elderly towards enrolment into cancer clinical trials.
        BMC Cancer. 2006; 6 (34–34)