title: Offering the option of randomized clinical trials to cancer patients who overestimate their prognoses with standard therapies.
abstract: We have shown that cancer patients' routine (and understandable) overestimations of their prognoses with standard therapy may inhibit their accrual to randomized clinical trials for which standard therapies are the alternative. Patients' appreciation of the rationale for a trial, and the potential benefit of trial participation, can only be enhanced if they understand their prognoses with standard therapy. However, clinical investigators may be reluctant to provide specific information that deflates patients' estimates of their prognoses. The routine withholding of information regarding the modest benefits of standard therapies may avoid patient distress, but such physician behavior is paternalistic and may deleteriously affect trial accrual. On the other hand, the routine communication of prognostic information will cause significant distress among patients and will perhaps be destabilizing to that minority of patients who would otherwise shun this information or truly cannot psychologically tolerate it. A middle ground between these extremes is the stepwise disclosure of potentially distressing information, wherein specific prognostical information is offered by physicians to patients and actually provided or communicated only after patients first understand the nature of it and then indicate their interest in receiving it. A practical disadvantage of this approach is its additional demand on physicians' time. Therefore, if impracticality is to be avoided and yet the approach fostered, clinical investigators might consider developing trial-specific, written or audiovisual materials for patient education about general background information. These could be employed prior to patient-physician dialogue and so enable physicians to focus on more sensitive subjects, such as prognosis with standard therapy.
authors.affiliation: Johns Hopkins Oncology Center, Johns Hopkins University School of Medicine, Baltimore, Maryland 21205.
authors.forename: J M
authors.initials: JM
authors.lastname: Sheldon
authors.forename: J H
authors.initials: JH
authors.lastname: Fetting
authors.forename: L A
authors.initials: LA
authors.lastname: Siminoff
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000188:drug therapy / Q000523:psychology* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D009364:Neoplasm Recurrence, Local / Q000523:psychology; D010358:Patient Participation / Q000523:psychology*; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000523:psychology*; D012307:Risk Factors