Breast CancerGMCNCT01329068
Patient Empowerment by Group Medical Consultations
A study testing individual consult and group medical consult in people with Breast Cancer and BRCA Mutation, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, BRCA Mutation
- What is being tested?
- individual consult and group medical consult
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
H.W.M. van Laarhoven, Md
About this study
Official title: Patient Empowerment by Group Medical Consultations in the Follow-up of Breast Cancer Survivors and Surveillance of Women With a BRCA Mutation
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.
- Conditions
- Breast Cancer, BRCA Mutation
- Being tested
- individual consult, group medical consult
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual consultBehavioural
regular individual consultations
group medical consultBehavioural
group medical consult
| Study group | Role | What they receive |
|---|---|---|
| Individual consult | Active comparator | regular individual consult Receives: Behavioral: individual consult |
| group medical consult | Active comparator | regular group medical consult Receives: Behavioral: group medical consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress (SCL-90) and empowerment (Cancer Empowerment Questionnaire)
Measured: BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
Secondary outcomes (1)
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
Measured: BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H.W.M. van Laarhoven, Md PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329068
- Sponsor's protocol ID
- UMCNONCO201006
- Acronym
- GMC
- Status last verified
- Oct 2011
- First submitted
- 31 Mar 2011
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21864353
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Empowerment by Group Medical Consultations in the Follow-up of Breast Cancer Survivors and Surveillance of Women With a BRCA Mutation
- ClinicalTrials.gov ID
- NCT01329068
- Acronym / sponsor ID
- GMC / UMCNONCO201006
- Conditions
- Breast Cancer, BRCA Mutation
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual consult | Active comparator | Behavioral: individual consultregular individual consult |
| group medical consult | Active comparator | Behavioral: group medical consultregular group medical consult |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual consultregular individual consultations | Behavioural | Individual consult |
| group medical consultgroup medical consult | Behavioural | group medical consult |
Primary outcome
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.
1 secondary outcome
Questionnaires for patients and health care professionals, observations and user measurements of the iPads.
Time frame: BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
- Derived from this study: PubMed 21864353Visser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H.W.M. van Laarhoven, Md PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual consult and group medical consult in people with Breast Cancer and BRCA Mutation, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact H.W.M. van Laarhoven, Md (+31 24 361 03 53, h.vanlaarhoven@onco.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01329068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2012.