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GMC
Sponsor study identifier
interventional
320
1 country
1
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 31, 2011
Actual (reported)April 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 5, 2011
Actual (reported)February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Psychological distress (SCL-90) and empowerment (Cancer Empowerment Questionnaire)
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.
BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
regular individual consult
regular group medical consult
regular individual consultations
group medical consult
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB, Netherlands
Visser A, Prins JB, Hoogerbrugge N, van Laarhoven HW. Group medical visits in the follow-up of women with a BRCA mutation: design of a randomized controlled trial. BMC Womens Health. 2011 Aug 24;11:39. doi: 10.1186/1472-6874-11-39.
H.W.M. van Laarhoven, Md PhD
Radboud University Medical Center
First Submitted
March 31, 2011
First Posted
April 5, 2011
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 20, 2012
Record last verified: 2011-10
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Source: ClinicalTrials.gov.
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