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

BMC Cancer

Eveline MA Bleiker³  Margreet GEM Ausems¹  Daniela EE Hahn³  Grace N Sidharta²  Irma Kluijt³  Neil K Aaronson²  Willem Eijzenga² 

[1]Division of Biomedical Genetics, University Medical Center Utrecht, Utrecht, The Netherlands

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

[3]The Netherlands Cancer Institute, Family Cancer Clinic, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands

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

Others  :  859137
DOI  :  10.1186/1471-2407-14-26

 received in 2013-12-19, accepted in 2014-01-10,  发布年份 2014

【 摘 要 】

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).

【 授权许可】

   
2014 Eijzenga et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Lindor NM, McMaster ML, Lindor CJ, Greene MH: Concise handbook of familial cancer susceptibility syndromes - second edition. J Natl Cancer Inst Monogr 2008, 1-93. doi:10.1093/jncimonographs/lgn001.
• [2]Butow PN, Lobb EA, Meiser B, Barratt A, Tucker KM: Psychological outcomes and risk perception after genetic testing and counselling in breast cancer: a systematic review. Med J Aust 2003, 178:77-81.
• [3]Meiser B, Butow P, Friedlander M, Barratt A, Schnieden V, Watson M, Brown J, Tucker K: Psychological impact of genetic testing in women from high-risk breast cancer families. Eur J Cancer 2002, 38:2025-2031.
• [4]Pasacreta JV: Psychosocial issues associated with genetic testing for breast and ovarian cancer risk: an integrative review. Cancer Invest 2003, 21:588-623.
• [5]Meiser B: Psychological impact of genetic testing for cancer susceptibility: an update of the literature. Psychooncology 2005, 14:1060-1074.
• [6]Douma KF, Aaronson NK, Vasen HF, Bleiker EM: Psychosocial issues in genetic testing for familial adenomatous polyposis: a review of the literature. Psychooncology 2008, 17:737-745.
• [7]Braithwaite D, Emery J, Walter F, Prevost AT, Sutton S: Psychological impact of genetic counseling for familial cancer: a systematic review and meta-analysis. Fam Cancer 2006, 5:61-75.
• [8]Broadstock M, Michie S, Marteau T: Psychological consequences of predictive genetic testing: a systematic review. Eur J Hum Genet 2000, 8:731-738.
• [9]Meiser B, Tucker K, Friedlander M, Barlow-Stewart K, Lobb E, Saunders C, Mitchell G: Genetic counselling and testing for inherited gene mutations in newly diagnosed patients with breast cancer: a review of the existing literature and a proposed research agenda. Breast Cancer Res 2008, 10:216. BioMed Central Full Text
• [10]Schlich-Bakker KJ, ten Kroode HF, Ausems MG: A literature review of the psychological impact of genetic testing on breast cancer patients. Patient Educ Couns 2006, 62:13-20.
• [11]Landsbergen KM, Prins JB, Brunner HG, Kraaimaat FW, Hoogerbrugge N: Genetic testing for Lynch syndrome in the first year of colorectal cancer: a review of the psychological impact. Fam Cancer 2009, 8:325-337.
• [12]Stromsvik N, Raheim M, Oyen N, Gjengedal E: Men in the women's world of hereditary breast and ovarian cancer–a systematic review. Fam Cancer 2009, 8:221-229.
• [13]Hamilton JG, Lobel M, Moyer A: Emotional distress following genetic testing for hereditary breast and ovarian cancer: a meta-analytic review. Health Psychol 2009, 28:510-518.
• [14]Douma KF, Aaronson NK, Vasen HF, Gerritsma MA, Gundy CM, Janssen EP, Vriends AH, Cats A, Verhoef S, Bleiker EM: Psychological distress and use of psychosocial support in familial adenomatous polyposis. Psychooncology 2010, 19:289-298.
• [15]Lammens CR, Bleiker EM, Verhoef S, Hes FJ, Ausems MG, Majoor-Krakauer D, Sijmons RH, van der Luijt RB, van den Ouweland AM, van Os TA, et al.: Psychosocial impact of Von Hippel-Lindau disease: levels and sources of distress. Clin Genet 2010, 77:483-491.
• [16]Meiser B, Irle J, Lobb E, Barlow-Stewart K: Assessment of the content and process of genetic counseling: a critical review of empirical studies. J Genet Couns 2008, 17:434-451.
• [17]Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J: The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res 2008, 17:179-193.
• [18]Luckett T, Butow P, King M: Improving patient outcomes through the routine use of patient‒reported data in cancer clinics: future directions. Psychooncology 2009, 18:1129-1138.
• [19]Greenhalgh J: The applications of PROs in clinical practice: what are they, do they work, and why? Qual Life Res 2009, 18:115-123.
• [20]Rosenbloom SK, Victorson DE, Hahn EA, Peterman AH, Cella D: Assessment is not enough: a randomized controlled trial of the effects of HRQL assessment on quality of life and satisfaction in oncology clinical practice. Psychooncology 2007, 16:1069-1079.
• [21]Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK: Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA 2002, 288:3027-3034.
• [22]Hilarius DL, Kloeg PH, Gundy CM, Aaronson NK: Use of health-related quality-of-life assessments in daily clinical oncology nursing practice: a community hospital-based intervention study. Cancer 2008, 113:628-637.
• [23]Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ: Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 2004, 22:714-724.
• [24]Street RL Jr, Makoul G, Arora NK, Epstein RM: How does communication heal? Pathways linking clinician-patient communication to health outcomes. Patient Educ Couns 2009, 74:295-301.
• [25]Eijzenga W, Bleiker EMA, Hahn DE, Kluijt I, Sidharta GN, Gundy CM, Aaronson NK: Psychosocial Aspects of Hereditary Cancer (PAHC) questionnaire: development and testing of a screening questionnaire for use in clinical cancer genetics. Psychooncology 2014. doi:10.1002/pon.3485
• [26]Tuinman MA, Gazendam-Donofrio SM, Hoekstra-Weebers JE: Screening and referral for psychosocial distress in oncologic practice: use of the Distress Thermometer. Cancer 2008, 113:870-878.
• [27]Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c869.
• [28]Scott NW, McPherson GC, Ramsay CR, Campbell MK: The method of minimization for allocation to clinical trials. a review. Control Clin Trials 2002, 23:662-674.
• [29]Carlson LE, Waller A, Mitchell AJ: Screening for distress and unmet needs in patients with cancer: review and recommendations. J Clin Oncol 2012, 30:1160-1177.
• [30]Lammens CR, Aaronson NK, Wagner A, Sijmons RH, Ausems MG, Vriends AH, Ruijs MW, van Os TA, Spruijt L, Gomez Garcia EB, et al.: Genetic testing in Li-Fraumeni syndrome: uptake and psychosocial consequences. J Clin Oncol 2010, 28:3008-3014.
• [31]Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta PsychiatrScand 1983, 67:361-370.
• [32]Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM: A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. PsycholMed 1997, 27:363-370.
• [33]Bleiker EM, Aaronson NK, Menko FH, Hahn DE, van Asperen CJ, Rutgers EJ, ten Kate LP, Leschot NJ: Genetic counseling for hereditary cancer: a pilot study on experiences of patients and family members. Patient Educ Couns 1997, 32:107-116.
• [34]Shrout PE, Fleiss JL: Intraclass correlations: uses in assessing rater reliability. Psychological bulletin 1979, 86:420.
• [35]de Raaf PJ, de Klerk C, Timman R, Busschbach JJ, Oldenmenger WH, van der Rijt CC: Systematic monitoring and treatment of physical symptoms to alleviate fatigue in patients with advanced cancer: a randomized controlled trial. J Clin Oncol 2013, 31:716-723.