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Open Access Study protocol

The efficacy of a standardized questionnaire in facilitating personalized communication about problems encountered in cancer genetic counseling: design of a randomized controlled trial

Willem Eijzenga1, Neil K Aaronson1, Irma Kluijt2, Grace N Sidharta1, Daniela EE Hahn2, Margreet GEM Ausems3 and Eveline MA Bleiker12*

Author Affiliations

1 The Netherlands Cancer Institute, Dept. of Psychosocial Research and Epidemiology, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands

2 The Netherlands Cancer Institute, Family Cancer Clinic, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands

3 Division of Biomedical Genetics, University Medical Center Utrecht, Utrecht, The Netherlands

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BMC Cancer 2014, 14:26  doi:10.1186/1471-2407-14-26

Published: 15 January 2014

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.

Discussion

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.

Trial registration

This study is registered at the Netherlands Trial Register (NTR3205) and ClinicalTrials.gov (NCT01562431).

Keywords:
Randomized controlled trial; Genetic counseling; Clinical genetics; Psychosocial problems; Hereditary cancers; Communication; Screening