OT3-02-03: Patient Empowerment by Group Medical Consultations in the Follow-Up of Breast Cancer Survivors and Surveillance of Women with a BRCA Mutation.
Authors: van Laarhoven HWM , Prins JB , Schlooz MS , Besselink RM , Bögemann L , van Koolwijk MPA , Hoogerbrugge N , Visser A 
Published: June 2012

Background: During usual follow-up care for breast cancer patients only little time is left for psychosocial support, while most patients experience several complaints, which may increase levels of distress or effect the quality of life. BRCA mutation carriers have a 40–80% life-time risk of developing breast cancer. They have a complex choice to make between yearly breast cancer surveillance or prophylactic mastectomy. Both options show increased survival rates.

To fulfill the needs for psychosocial support and information we have introduced group medical consultations (GMCs). A GMC provides individual medical visits conducted within a group. This 90 minute group-visit with 8–12 patients gives patients the opportunity to spend more time with their clinician and a behavioral health professional and learn from other patients experiencing similar topics. However, it should be noted that group sessions may increase fear in some patients.

Trial design: This multicenter randomized controlled trial will assess the effect of GMCs compared to individual visits for patients in the follow-up after breast cancer and for women with a BRCA mutation. The intervention group will participate in a GMC once, while the control group will have usual care.

Eligibility criteria: Inclusion criteria for the follow-up of breast cancer patients are: histologically proven breast cancer; age ≥18 years; primary treatment completed maximally 5 years ago. For BRCA mutation carriers inclusion criteria are: carrier of a BRCA1 or BRCA2 mutation; diagnosed maximally 2 years ago; age ≥25 years. Exclusion criteria for both groups are: currently involved in a diagnostic work-up because of a suspicion of breast cancer; metastatic breast cancer; current psychiatric disorder; insufficient command of the Dutch language. A history of prophylactic mastectomy is an exclusion criteria only for BRCA mutation carriers.

Study endpoint: Primary outcomes in this study are empowerment and psychological distress. In addition, the effects on cancer worry, information needs and information giving, self-examination of the breasts, treatment compliance, patient satisfaction, quality of life and costs of care (secondary outcome measures) will be studied.

Statistical methods: To assess a clinically relevant effect of GMCs on psychological distress with a power of 80%, a two-side significance of 5%, and a standard deviation of 45, 80 patients need to be included in each group. Randomization will take place per patient in blocks of 16 patients. Differences between baseline and post-test between the two groups will be compared by using ANCOVA for primary outcomes and ANOVA or mixed model for secondary analysis.

Accrual: Patients are currently being recruited at the Radboud University Nijmegen Medical Center. In the future other centers in the Netherlands will participate. Presently (21th june 2011) a total number of 37 patients have been included since start of the study (april 2011). The expected end of accrual of 320 patients will be December 2012.

Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr OT3-02-03.