title: The efficacy of a standardized questionnaire in facilitating personalized communication about problems encountered in cancer genetic counseling: design of a randomized controlled trial.
abstract: BACKGROUND
  Individuals with a personal or family history of cancer, can opt for genetic counseling and DNA-testing. Approximately 25% of these individuals experience clinically relevant levels of psychosocial distress, depression and/or anxiety after counseling. These problems are frequently left undetected by genetic counselors. The aim of this study is to evaluate the efficacy of a cancer genetics-specific screening questionnaire for psychosocial problems, the 'Psychosocial Aspects of Hereditary Cancer (PAHC) questionnaire' together with the Distress Thermometer, in: (1) facilitating personalized counselor-counselee communication; (2) increasing counselors' awareness of their counselees' psychosocial problems; and (3) facilitating the management of psychosocial problems during and after genetic counseling.
  
  
  METHODS
  This multicenter, randomized controlled trial will include 264 individuals undergoing cancer genetic counseling in two family cancer clinics in the Netherlands. Participants will be randomized to either: (1) an intervention group that completes the PAHC questionnaire, the results of which are made available to the genetic counselor prior to the counseling session; or (2) a control group that completes the PAHC questionnaire, but without feedback being given to the genetic counselor. The genetic counseling sessions will be audiotaped for content analysis. Additionally, study participants will be asked to complete questionnaires at baseline, three weeks after the initial counseling session, and four months after a telephone follow-up counseling session. The genetic counselors will be asked to complete questionnaires at the start of and at completion of the study, as well as a checklist directly after each counseling session. The questionnaires/checklists of the study include items on communication during genetic counseling, counselor awareness of their clients' psychosocial problems, the (perceived) need for professional psychosocial support, cancer worries, general distress, specific psychosocial problems, satisfaction with care received, and experience using the PAHC questionnaire.
  
  
  CONCLUSIONS
  This study will provide empirical evidence regarding the efficacy of a relatively brief psychosocial screening questionnaire in terms of facilitating personalized communication, increasing counselors' awareness, and optimizing management of psychosocial problems in the cancer genetic counseling setting.
  
  
  BACKGROUND
  This study is registered at the Netherlands Trial Register (NTR3205) and ClinicalTrials.gov (NCT01562431).
authors.forename: Willem
authors.initials: W
authors.lastname: Eijzenga
authors.forename: Neil K
authors.initials: NK
authors.lastname: Aaronson
authors.forename: Irma
authors.initials: I
authors.lastname: Kluijt
authors.forename: Grace N
authors.initials: GN
authors.lastname: Sidharta
authors.forename: Daniela Ee
authors.initials: DE
authors.lastname: Hahn
authors.forename: Margreet Gem
authors.initials: MG
authors.lastname: Ausems
authors.affiliation: The Netherlands Cancer Institute, Dept, of Psychosocial Research and Epidemiology, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands. e.bleiker@nki.nl.
authors.forename: Eveline Ma
authors.initials: EM
authors.lastname: Bleiker
mesh_terms: D001007:Anxiety / Q000175:diagnosis / Q000209:etiology; D001291:Attitude of Health Personnel; D001364:Awareness; D003863:Depression / Q000175:diagnosis / Q000209:etiology; D005817:Genetic Counseling / Q000379:methods*; D020022:Genetic Predisposition to Disease; D005820:Genetic Testing; D040941:Heredity; D006801:Humans; D009369:Neoplasms / Q000175:diagnosis / Q000235:genetics* / Q000628:therapy; D009426:Netherlands; D010375:Pedigree; D010641:Phenotype; D011237:Predictive Value of Tests; D011369:Professional-Patient Relations; D011379:Prognosis; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D013315:Stress, Psychological / Q000175:diagnosis / Q000209:etiology; D011795:Surveys and Questionnaires