title: Distress among caregivers of phase I trial participants: a cross-sectional study.
abstract: OBJECTIVE
  The number of patients with cancer enrolling in phase I trials is expected to increase as these trials incorporate patient selection and exhibit greater efficacy in the era of targeted therapies. Despite the fact that people with advanced cancer often require a caregiver, little is known about the experience of caregivers of people enrolling in oncology phase I clinical trials. We conducted a cross-sectional study assessing the distress and emotion regulation of caregivers of phase I trial participants to inform the design of future interventions targeting the unique needs of this population.
  
  
  METHODS
  Caregivers of oncology patients were approached at the patient's phase I clinical trial screening visit. Caregiver participants completed a one-time survey incorporating validated instruments to comprehensively assess distress and emotion regulation. Basic demographic information about both the caregiver and patient was collected.
  
  
  RESULTS
  Caregivers exhibited greater distress than population norms. Emotion regulation was also moderately impaired. Respondents identified positive aspects of caregiving despite exhibiting moderate distress.
  
  
  CONCLUSIONS
  Enrollment of a patient in a phase I clinical trial is a time of stress for their caregivers. This pilot study demonstrates the feasibility of engaging caregivers of phase I trial participants and the need to better support them through this component of their caregiving experience.
authors.affiliation: Division of Medical Oncology, Department of Medicine, University of Colorado School of Medicine, MS 8117, 12801 E 17th Avenue, Aurora, CO, 80045, USA, elizabeth.kessler@ucdenver.edu.
authors.forename: Elizabeth R
authors.initials: ER
authors.lastname: Kessler
authors.forename: Angela
authors.initials: A
authors.lastname: Moss
authors.forename: S Gail
authors.initials: SG
authors.lastname: Eckhardt
authors.forename: Mark L
authors.initials: ML
authors.lastname: Laudenslager
authors.forename: Kristin
authors.initials: K
authors.lastname: Kilbourn
authors.forename: Iris B
authors.initials: IB
authors.lastname: Mauss
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Bowles
authors.forename: Sharon
authors.initials: S
authors.lastname: Hecker
authors.forename: Diane L
authors.initials: DL
authors.lastname: Fairclough
authors.forename: Jean S
authors.initials: JS
authors.lastname: Kutner
mesh_terms: D000223:Adaptation, Psychological; D017028:Caregivers / Q000523:psychology*; D017321:Clinical Trials, Phase I as Topic / Q000523:psychology; D003430:Cross-Sectional Studies; D003710:Demography; D005260:Female; D006801:Humans; D008875:Middle Aged; D020380:Needs Assessment; D009367:Neoplasm Staging; D009369:Neoplasms / Q000473:pathology / Q000523:psychology / Q000628:therapy; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D013315:Stress, Psychological / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D014481:United States