Patient Empowerment by Group Medical Consultations (GMC)
Primary Purpose
Breast Cancer, BRCA Mutation
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
individual consult
group medical consult
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring 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
Sites / Locations
- Radboud University Nijmegen Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Individual consult
group medical consult
Arm Description
regular individual consult
regular group medical consult
Outcomes
Primary Outcome Measures
Psychological distress (SCL-90) and empowerment (Cancer Empowerment Questionnaire)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01329068
First Posted
March 31, 2011
Last Updated
January 19, 2012
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01329068
Brief Title
Patient Empowerment by Group Medical Consultations
Acronym
GMC
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
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, BRCA Mutation
Keywords
breast cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individual consult
Arm Type
Active Comparator
Arm Description
regular individual consult
Arm Title
group medical consult
Arm Type
Active Comparator
Arm Description
regular group medical consult
Intervention Type
Behavioral
Intervention Name(s)
individual consult
Intervention Description
regular individual consultations
Intervention Type
Behavioral
Intervention Name(s)
group medical consult
Intervention Description
group medical consult
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Questionnaires for patients and health care professionals, observations and user measurements of the iPads.
Description
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
H.W.M. van Laarhoven, Md
Phone
+31 24 361 03 53
Email
h.vanlaarhoven@onco.umcn.nl
First Name & Middle Initial & Last Name or Official Title & Degree
A. Visser
Phone
+31 24 361 03 54
Email
a.visser@onco.umcn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H.W.M. van Laarhoven, Md PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H.W.M. van Laarhoven, Md
12. IPD Sharing Statement
Citations:
PubMed Identifier
21864353
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.
Results Reference
derived
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Patient Empowerment by Group Medical Consultations
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