title: Patients' perceived tolerance of side effects in phase I cancer clinical trials: A qualitative study.
abstract: This qualitative study aimed to explore cancer patients' perceived tolerance of side effects in phase I drug trials. Patients with solid tumours receiving molecularly targeted agents with/without chemotherapy were eligible for inclusion. In-depth semi-structured interviews were carried out with 17 patients with a median [range] age of 63 [41-72] years. Treatment was discontinued in seven patients. Verbatim transcripts of the audio-taped interviews were analysed using a constructivist grounded theory approach. Four conceptual categories emerged from data analysis, labelled "suffering from side effects" comprising a range of symptoms, psychosocial or role disturbances; "striving to cope with side effects" reflecting psychological strategies for managing side effects; "hoping" reflecting expectations about treatment efficacy and relief from side effects; and "appraisal of care." Among patients remaining in the trial, treatment was currently perceived as fairly tolerable. For most respondents, whether still in a trial or not, treatment discontinuation could not be justified by the non-tolerance of treatment side effects. These results question the adequacy of patient-perceived tolerance reports to determine an optimal drug dose for phase II trials. Confronted with patients' hopes and inappropriate beliefs, communication is challenging in phase I trials and could benefit from facilitating psychosocial interventions.
authors.affiliation: Psycho-Oncology Unit, Institut Curie, Paris, France.|Psychopathology and Health Process Laboratory (EA 4057), Psychology Institute, University Paris Descartes, Boulogne-Billancourt, France.
authors.forename: A
authors.initials: A
authors.lastname: Brédart
authors.affiliation: Psychopathology and Health Process Laboratory (EA 4057), Psychology Institute, University Paris Descartes, Boulogne-Billancourt, France.
authors.forename: S
authors.initials: S
authors.lastname: Bodson
authors.affiliation: Department of Medical Oncology, Institut Curie, Paris & Saint-Cloud, France.|EA7285, Versailles-Saint-Quentin-en-Yvelines University, Montigny-le-Bretonneux, France.
authors.forename: C
authors.initials: C
authors.lastname: Le Tourneau
authors.affiliation: Psycho-Oncology Unit, Institut Curie, Paris, France.|Psychopathology and Health Process Laboratory (EA 4057), Psychology Institute, University Paris Descartes, Boulogne-Billancourt, France.
authors.forename: C
authors.initials: C
authors.lastname: Flahault
authors.affiliation: Methodology and Quality of Life in Oncology Unit (EA 3181) & Quality of Life and Cancer Clinical Research Platform, CHU Besançon, France.
authors.forename: F
authors.initials: F
authors.lastname: Bonnetain
authors.affiliation: Psycho-Oncology Unit, Institut Curie, Paris, France.
authors.forename: A
authors.initials: A
authors.lastname: Beaudeau
authors.affiliation: Department of Medical Oncology, Institut Curie, Paris & Saint-Cloud, France.|EA7285, Versailles-Saint-Quentin-en-Yvelines University, Montigny-le-Bretonneux, France.
authors.forename: E
authors.initials: E
authors.lastname: Coquan
authors.affiliation: Psycho-Oncology Unit, Institut Curie, Paris, France.|Inserm, U 669, Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Dolbeault
authors.affiliation: Gustave Roussy Cancer Campus, Villejuif, France.
authors.forename: X
authors.initials: X
authors.lastname: Paoletti
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D017321:Clinical Trials, Phase I as Topic / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058990:Molecular Targeted Therapy / Q000009:adverse effects*; D009369:Neoplasms / Q000188:drug therapy* / Q000523:psychology; D036301:Qualitative Research
chemical_list: D000970:Antineoplastic Agents
keywords: health-related quality of life; molecular targeted agents; patients’ subjective experiences; phase I clinical trial; qualitative study; treatment tolerance