BRCA Mutation, Breast Cancer
Conditions
Keywords
breast cancer
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.
Interventions
BEHAVIORALindividual consult
regular individual consultations
BEHAVIORALgroup medical consult
group medical consult
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | * 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 |
Countries
Netherlands
Contacts
Primary ContactH.W.M. van Laarhoven, Md
Backup ContactA. Visser
Outcome results
None listed