An interventional study of individual consult and group medical consult in Breast Cancer and BRCA Mutation, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-20.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Supportive care
Carriers of a BRCA mutation have a significantly increased risk to develop breast cancer in the course of their lives . They face a difficult choice: either a preventive removal of the breast(s) or an intensive inspection process.
After primary treatment of breast cancer, patients will be followed for 5-10 years to diagnose recurrence or a new primary tumor in an early stage; to support the patient during hormonal treatment; to educate the patient about risk factors and healthy life style; and to provide psychosocial support.
Currently, follow-up of breast cancer patients and surveillance of BRCA mutation carriers is offered in regular, one-to-one medical visits. Experience shows that in an individual visit it is often not possible to give all aspects that are important, enough attention. The group medical consultation (GMC) is a new form of medical visits where the physician or nurse practitioner performs a series of one-to-one consultations in the presence of 8 to10 other patients. A social worker accompanies this process. Patients in group consultations may gather more information because they learn from each other and there is relatively more time compared to a regular consultation. Research shows that both patients and caregivers are more satisfied with care after a group consultation compared to individual visits. After a GMC the participants from the breast cancer GMCs will be provided with a dedicated iPad for 3 months. Using this iPad, patients can contact the women they have met during the GMC as well as health care professionals by several communication channels, including virtual group meetings. This approach provides a unique combination of both social support and professional education concerning survivorship in an e-health environment.However, it is also known that group sessions may be counterproductive for some patients, for example because they are frightened by the stories of others. The goal of this study is to examine whether group visits (in combination with dedicated iPads) are beneficial to women with a BRCA mutation and for patients in follow-up after breast cancer.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 320 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants: patients in follow-up after breast cancer
Participants: women with a BRCA mutation
Exclusion Criteria:
Participants: patients in follow-up after breast cancer
Participants: women with a BRCA mutation
regular individual consult
Behavioral: individual consult
regular group medical consult
Behavioral: group medical consult
regular individual consultations
group medical consult
Psychological distress (SCL-90) and empowerment (Cancer Empowerment Questionnaire)
Time frame: BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
Questionnaires for patients and health care professionals, observations and user measurements of the iPads.
* Cancer worry (CWS) * Quality of life (EORTC QLQ C30 and BR23) * Compliance to hormonal treatment (MARS) (for breast cancer only) * Cost-effectiveness (TIC-P- part 1 and EuroQol-5D) * Information needs and giving * Self-breast examination (for BRCA only) * Decisions for prophylactic mastectomy or surveillance (for BRCA only) * Patient satisfaction IPads: * Frequency of using the iPad * Content of use * Frequency and ways of contacting other patients * Content of the online meetings
Time frame: BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center