Patient, Relative and Staff Experiences of Clinical Trial Participation in Neurooncology: “Maybe You Can Also Show the Positive, No Matter How It Ends”

References

• Lapointe S, Perry A, Butowski NA. Primary brain tumours in adults. Lancet. 2018;392(10145):432–446. doi:10.1016/S0140-6736(18)30990-5
   PubMed Web of Science ®Google Scholar
• Leibetseder A, Preusser M, Berghoff AS. New Approaches with Precision Medicine in Adult Brain Tumors. Cancers. 2022;14(3):712. doi:10.3390/cancers14030712
   PubMed Web of Science ®Google Scholar
• Magge RS, Barbaro M, Fine HA. Innovations in Neuro-Oncology. World Neurosurg. 2021;151:386–391. doi:10.1016/j.wneu.2021.02.093
   PubMed Web of Science ®Google Scholar
• Picca A, Guyon D, Santonocito OS, et al. Innovating Strategies and Tailored Approaches in Neuro-Oncology. Cancers. 2022;14(5):1124. doi:10.3390/cancers14051124
   PubMed Web of Science ®Google Scholar
• Ownsworth T. Coping with the Unthinkable: psychosocial Advances in the Management of Primary Brain Tumour. Brain Impairment. 2016;17(3):265–272. doi:10.1017/BrImp.2016.19
   Web of Science ®Google Scholar
• Sinha R, Stephenson JM, Price SJ. A systematic review of cognitive function in patients with glioblastoma undergoing surgery. Neurooncol Pract. 2020;7(2):131–142. doi:10.1093/nop/npz018
   PubMed Web of Science ®Google Scholar
• Li M, Shi Q, Yan L, et al. A Qualitative Systematic Review of the Experiences and Needs of Patients With Gliomas. Oncol Nurs Forum. 2020;47(5):E120–e130. doi:10.1188/20.Onf.E120-e130
   PubMed Web of Science ®Google Scholar
• Sterckx W, Coolbrandt A, Dierckx de Casterlé B, et al. The impact of a high-grade glioma on everyday life: a systematic review from the patient’s and caregiver’s perspective. Eur J Oncol Nurs. 2013;17(1):107–117. doi:10.1016/j.ejon.2012.04.006
   PubMed Web of Science ®Google Scholar
• Piil K, Jakobsen J, Christensen KB, et al. Needs and preferences among patients with high-grade glioma and their caregivers - A longitudinal mixed methods study. Eur J Cancer Care. 2018;27(2):e12806. doi:10.1111/ecc.12806
   PubMed Web of Science ®Google Scholar
• Sterckx W, Coolbrandt A, Clement P, et al. Living with a high-grade glioma: a qualitative study of patients’ experiences and care needs. Eur J Oncol Nurs. 2015;19(4):383–390. doi:10.1016/j.ejon.2015.01.003
   PubMed Web of Science ®Google Scholar
• Pertz M, Schlegel U, Thoma P. Sociocognitive Functioning and Psychosocial Burden in Patients with Brain Tumors. Cancers. 2022;14(3):767. doi:10.3390/cancers14030767
   PubMed Web of Science ®Google Scholar
• Applebaum AJ, Kryza-Lacombe M, Buthorn J, DeRosa A, Corner G, Diamond EL. Existential distress among caregivers of patients with brain tumors: a review of the literature. Neurooncol Pract. 2016;3(4):232–244. doi:10.1093/nop/npv060
   PubMed Web of Science ®Google Scholar
• Catt S, Chalmers A, Fallowfield L. Psychosocial and supportive-care needs in high-grade glioma. Lancet Oncol. 2008;9(9):884–891. doi:10.1016/S1470-2045(08)70230-4
   PubMed Web of Science ®Google Scholar
• Halkett GKB, Lobb EA, Oldham L, Nowak AK. The information and support needs of patients diagnosed with High Grade Glioma. Patient Educ Couns. 2010;79(1):112–119. doi:10.1016/j.pec.2009.08.013
   PubMed Web of Science ®Google Scholar
• Ulrich CM, Knafl KA, Ratcliffe SJ, et al. Developing a Model of the Benefits and Burdens of Research Participation in Cancer Clinical Trials. AJOB Prim Res. 2012;3(2):10–23. doi:10.1080/21507716.2011.653472
   PubMedGoogle Scholar
• Naidoo N, Nguyen VT, Ravaud P, et al. The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence. BMC Med. 2020;18(1):6. doi:10.1186/s12916-019-1476-5
   PubMed Web of Science ®Google Scholar
• Lee EQ, Chukwueke UN, Hervey-Jumper SL, et al. Barriers to accrual and enrollment in brain tumor trials. Neuro-Oncology. 2019;21(9):1100–1117. doi:10.1093/neuonc/noz104
   PubMed Web of Science ®Google Scholar
• Lyons E, Coyle A, eds. Analysing Qualitative Data in Psychology. Third edition ed. SAGE; 2021.
   Google Scholar
• Wick W, Dettmer S, Berberich A, et al. N2M2 (NOA-20) phase I/II trial of molecularly matched targeted therapies plus radiotherapy in patients with newly diagnosed non-MGMT hypermethylated glioblastoma. Neuro Oncol. 2019;21(1):95–105. doi:10.1093/neuonc/noy161
   PubMed Web of Science ®Google Scholar
• Bunse L, Rupp AK, Poschke I, et al. AMPLIFY-NEOVAC: a randomized, 3-arm multicenter phase I trial to assess safety, tolerability and immunogenicity of IDH1-vac combined with an immune checkpoint inhibitor targeting programmed death-ligand 1 in isocitrate dehydrogenase 1 mutant gliomas. Neurol Res Pract. 2022;4(1):20. doi:10.1186/s42466-022-00184-x
   PubMedGoogle Scholar
• Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies:Guided by Information Power. Qualitative Health Research. 2016;26(13):1753–1760. doi:10.1177/1049732315617444
   PubMed Web of Science ®Google Scholar
• Braun V, Clarke V. Should I use TA? Should I not use TA? Comparing reflexive thematic analysis and other pattern-based qualitative analytic approaches. Counselling Psychother Res. 2021;21(1):37–47. doi:10.1002/capr.12360
   Web of Science ®Google Scholar
• Knifed E, Lipsman N, Mason W, Bernstein M. Patients’ perception of the informed consent process for neurooncology clinical trials. Neuro-Oncology. 2008;10(3):348–354. doi:10.1215/15228517-2008-007
   PubMed Web of Science ®Google Scholar
• Sutton K. The impact on quality of life for people with brain tumours of entering a research trial involving new anti-cancer agents. Eur J Oncol Nurs. 2013;17(4):396–401. doi:10.1016/j.ejon.2012.12.003
   PubMed Web of Science ®Google Scholar
• Sulmasy D, Astrow A, He M, et al. The Culture of Faith and Hope Patients’ Justifications for Their High Estimations of Expected Therapeutic Benefit When Enrolling in Early Phase Oncology Trials. Cancer. 2010;116:3702–3711. doi:10.1002/cncr.25201
   PubMed Web of Science ®Google Scholar
• Albert K, Appelbaum P, Dunn LB, Lidz CW, Overton EVE, Pivovarova E. Why Is Therapeutic Misconception So Prevalent?. Cam Q Healthc Ethics. 2015;24(2):231–241. doi:10.1017/S096318011400053X
   PubMed Web of Science ®Google Scholar
• Strzebonska K, Waligora M. Umbrella and basket trials in oncology: ethical challenges. BMC Med Ethics. 2019;20(1):58. doi:10.1186/s12910-019-0395-5
   PubMed Web of Science ®Google Scholar
• Saraf A, Trippa L, Rahman R. Novel Clinical Trial Designs in Neuro-Oncology. Neurotherapeutics. 2022;19(6):1844–1854. doi:10.1007/s13311-022-01284-x
   PubMed Web of Science ®Google Scholar
• Cavers D, Hacking B, Erridge SC, Morris PG, Kendall M, Murray SA. Adjustment and support needs of glioma patients and their relatives: serial interviews. Psycho-Oncology. 2013;22(6):1299–1305. doi:10.1002/pon.3136
   PubMed Web of Science ®Google Scholar
• Clayton J, Hancock K, Parker S, et al. Sustaining Hope when Communicating with Terminally Ill Patients and Their Families: a Systematic Review. Psycho-Oncology. 2008;17:641–659. doi:10.1002/pon.1288
   PubMed Web of Science ®Google Scholar
• Evans W, Tulsky J, Back A, Arnold R. Communication at Times of Transitions: how to Help Patients Cope with Loss and ReDefine Hope. Cancer j. 2005;12:417–424. doi:10.1097/00130404-200609000-00010
   Web of Science ®Google Scholar
• Reeder-Hayes KE, Roberts MC, Henderson GE, Dees EC. Informed Consent and Decision Making Among Participants in Novel-Design Phase I Oncology Trials. J Oncol Pract. 2017;13(10):e863–e873. doi:10.1200/jop.2017.021303
   PubMed Web of Science ®Google Scholar
• van Vliet L, Francke A, Tomson S, Plum N, Wall E, Bensing J. When cure is no option: how explicit and hopeful can information be given? A qualitative study in breast cancer. Patient Educ Couns. 2011;90. doi:10.1016/j.pec.2011.03.021
   PubMed Web of Science ®Google Scholar
• Moore S. A need to try everything: patient participation in phase I trials. J Adv Nurs. 2001;33(6):738–747. doi:10.1046/j.1365-2648.2001.01715.x
   PubMed Web of Science ®Google Scholar
• Godskesen T, Nygren P, Nordin K, Hansson M, Kihlbom U. Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation. Support Care Cancer. 2013;21(11):3137–3142. doi:10.1007/s00520-013-1891-7
   PubMed Web of Science ®Google Scholar
• McGrath-Lone L, Ward H, Schoenborn C, Day S. The effects of cancer research participation on patient experience: a mixed-methods analysis. Eur J Cancer Care. 2016;25(6):1056–1064. doi:10.1111/ecc.12336
   PubMed Web of Science ®Google Scholar
• Kost RG, Lee LM, Yessis J, Coller BS, Henderson DK. Assessing research participants’ perceptions of their clinical research experiences. Clin Transl Sci. 2011;4(6):403–413. doi:10.1111/j.1752-8062.2011.00349.x
   PubMed Web of Science ®Google Scholar
• Locock L, Smith L. Personal experiences of taking part in clinical trials – a qualitative study. Patient Educ Couns. 2011;84(3):303–309. doi:10.1016/j.pec.2011.06.002
   PubMed Web of Science ®Google Scholar
• Murphy M, McCaughan E, Carson MA, Donovan M, Wilson RH, Fitzsimons D. Nothing to lose: a grounded theory study of patients’ and healthcare professionals’ perspectives of being involved in the consent process for oncology trials with non-curative intent. BMC Palliat Care. 2020;19(1):166. doi:10.1186/s12904-020-00661-7
   PubMed Web of Science ®Google Scholar
• Hutchison C. Phase I trials in cancer patients: participants’ perceptions. Eur J Cancer Care. 1998;7(1):15–22. doi:10.1046/j.1365-2354.1998.00062.x
   PubMedGoogle Scholar
• Hochschild AR. Emotion Work, Feeling Rules, and Social Structure. Am J Sociol. 1979;85(3):551–575.
   Web of Science ®Google Scholar
• Houghton C, Dowling M, Meskell P, et al. Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis. Cochrane Database Syst Rev. 2020;10:Mr000045. doi:10.1002/14651858.MR000045.pub2
   PubMedGoogle Scholar
• Resnik DB. The clinical investigator-subject relationship: a contextual approach. Philos Ethics Humanit Med. 2009;4:16. doi:10.1186/1747-5341-4-16
   PubMedGoogle Scholar
• Melo-Martín I, Ho A. Beyond informed consent: the therapeutic misconception and trust. J Med Ethics. 2008;34:202–205. doi:10.1136/jme.2006.019406
   PubMed Web of Science ®Google Scholar
• Lidz CW, Appelbaum PS. The Therapeutic Misconception: problems and Solutions. Med Care. 2002;40(9).
   PubMed Web of Science ®Google Scholar
• Sawyer C, Preston L, Taylor S, et al. Oncology patients’ experiences in experimental medicine cancer trials: a qualitative study. BMJ Open. 2021;11(10):e047813. doi:10.1136/bmjopen-2020-047813
   PubMed Web of Science ®Google Scholar
• Cox K. Enhancing cancer clinical trial management: recommendations from a qualitative study of trial participants’ experiences. Psycho-Oncology. 2000;9(4):314–322. doi:10.1002/1099-1611(200007/08)9:4<314::AID-PON464>3.0.CO;2-C
   PubMed Web of Science ®Google Scholar
• Viljoen B, Chambers SK, Dunn J, Ralph N, March S. Deciding to Enrol in a Cancer Trial: a Systematic Review of Qualitative Studies. J Multidiscip Healthc. 2020;13:1257–1281. doi:10.2147/jmdh.S266281
   PubMed Web of Science ®Google Scholar
• Gregersen TA, Birkelund R, Wolderslund M, Netsey-Afedo ML, Steffensen KD, Ammentorp J. What matters in clinical trial decision-making: a systematic review of interviews exploring cancer patients’ experiences. Scand J Caring Sci. 2019;33(2):266–278. doi:10.1111/scs.12637
   PubMed Web of Science ®Google Scholar
• Warnock C, Lord K, Taylor B, Tod A. Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (Mars 2). Trials. 2019;20(1):598. doi:10.1186/s13063-019-3692-x
   PubMed Web of Science ®Google Scholar
• Lobb EA, Halkett GK, Nowak AK. Patient and caregiver perceptions of communication of prognosis in high grade glioma. J Neurooncol. 2011;104(1):315–322. doi:10.1007/s11060-010-0495-z
   PubMed Web of Science ®Google Scholar
• Rosenblum ML, Kalkanis S, Goldberg W, et al. Odyssey of hope: a physician’s guide to communicating with brain tumor patients across the continuum of care. J Neuro-Oncol. 2009;92(3):241–251. doi:10.1007/s11060-009-9828-1
   PubMed Web of Science ®Google Scholar
• Strang P, Bergqvist J. Breast Cancer Patients Preferences For Truth Vs Hope Is Dynamic And Change During Late Lines of Palliative Chemotherapy. J Pain Sympt Manage. 2019;57. doi:10.1016/j.jpainsymman.2018.12.336
   PubMedGoogle Scholar
• Blakely K, Karanicolas P, Wright F, Conn L. Optimistic honesty: understanding surgeon and patient perspectives on hopeful communication in pancreatic cancer care. HPB. 2017;19. doi:10.1016/j.hpb.2017.04.001
   Web of Science ®Google Scholar
• Malmström A, Åkesson L, Milos P, et al. Do I want to know it all? A qualitative study of glioma patients’ perspectives on receiving information about their diagnosis and prognosis. Support Care Cancer. 2021;29:1–8. doi:10.1007/s00520-020-05846-7
   PubMed Web of Science ®Google Scholar
• Friedrichsen M, Lindholm A, Milberg A. Experiences of truth disclosure in terminally ill cancer patients in palliative home care. Palliative Supportive Care. 2011;9(2):173–180. doi:10.1017/S1478951511000046
   PubMed Web of Science ®Google Scholar
• Pii KH, Schou LH, Piil K, Jarden M. Current trends in patient and public involvement in cancer research: a systematic review. Health Expectations. 2019;22(1):3–20. doi:10.1111/hex.12841
   PubMed Web of Science ®Google Scholar