Clinical trial NCT01329068: Patient Empowerment by Group Medical Consultations
Official title: Patient Empowerment by Group Medical Consultations in the Follow-up of Breast Cancer Survivors and Surveillance of Women With a BRCA Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
BRCA Mutation
Keywords: breast cancer
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Participants: patients in follow-up after breast cancer

* Women ≥ 18 years of age with histologically proven breast cancer.
* Primary treatment (surgery, radiotherapy, chemotherapy) completed maximally 5 years ago.

Participants: women with a BRCA mutation

* Women ≥ 25 years of age with a proven BRCA1 or BRCA2 mutation.
* Carrier of a BRCA1 or BRCA2 mutation, diagnosed maximally two years before inclusion.

Exclusion Criteria:

Participants: patients in follow-up after breast cancer

* Metastatic breast cancer
* Currently involved in a diagnostic work-up because of a suspicion of breast cancer, either primary or metastatic.
* A history of prophylactic mastectomy.
* Current psychiatric disease precluding consultations in a group.
* Insufficient command of the Dutch language to be able to follow a group discussion and/or to fill out a Dutch questionnaire

Participants: women with a BRCA mutation

* Metastatic breast cancer
* Currently involved in a diagnostic work-up because of a suspicion of breast cancer, either primary or metastatic.
* A history of prophylactic mastectomy.
* Current psychiatric disease precluding consultations in a group.
* Insufficient command of the Dutch language to be able to follow a group discussion and/or to fill out a Dutch questionnaire

Primary outcomes:
measure: Psychological distress (SCL-90) and empowerment (Cancer Empowerment Questionnaire)
timeFrame: BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
Secondary outcomes:
measure: Questionnaires for patients and health care professionals, observations and user measurements of the iPads.
timeFrame: BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: H.W.M. van Laarhoven, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.