title: Impact of quality of life on patient expectations regarding phase I clinical trials.
abstract: OBJECTIVE
  Quality of life (QOL) is increasingly recognized as a critical cancer-treatment outcome measure, but little is known about the impact of QOL on the patient decision-making process. A pilot study was conducted in an effort to (1) measure the expectations of patients, physicians, and research nurses regarding the potential benefits and toxicities from experimental and standard therapies, and (2) determine the relationship of QOL to patient perceptions regarding treatment options.
  
  
  METHODS
  Thirty cancer patients enrolling in phase I clinical trials, their physicians, and their research nurses were administered questionnaires that assessed demographics, QOL, and treatment expectations.
  
  
  RESULTS
  Compared with their physicians, patients overestimated potential benefits and toxicities from experimental therapy (mean expected benefit, 59.8% v 23.8%, P <.01; mean expected toxicity, 29.8% v 16.0%, P <.01). Patients estimated a greater potential for benefit (59.8% v 36.8%, P <.01) and less potential for toxicity (29.8% v 45.6%, P =.01) for experimental therapy, compared with standard therapy. Short Form-36 general health perception correlated with patient perception of potential benefit from experimental therapy (r =.48, P =.01).
  
  
  CONCLUSIONS
  Participants in phase I clinical trial have high expectations regarding the success of experimental therapy and discount potential toxicity. Patient QOL may affect the expectation of benefit from experimental therapy and, ultimately, treatment choice. Understanding the interactions between QOL and patient expectations may guide the development of improved strategies to present appropriate information to patients considering early-phase clinical trials.
authors.affiliation: Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.
authors.forename: J D
authors.initials: JD
authors.lastname: Cheng
authors.forename: J
authors.initials: J
authors.lastname: Hitt
authors.forename: B
authors.initials: B
authors.lastname: Koczwara
authors.forename: K A
authors.initials: KA
authors.lastname: Schulman
authors.forename: C B
authors.initials: CB
authors.lastname: Burnett
authors.forename: D J
authors.initials: DJ
authors.lastname: Gaskin
authors.forename: J H
authors.initials: JH
authors.lastname: Rowland
authors.forename: N J
authors.initials: NJ
authors.lastname: Meropol
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects; D017321:Clinical Trials, Phase I as Topic; D003657:Decision Making; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy; D017060:Patient Satisfaction; D010817:Physician-Patient Relations; D010865:Pilot Projects; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents