Patient Empowerment by Group Medical Consultations

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01329068
• Other study ID #: UMCNONCO201006
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2011
• Last updated: January 19, 2012
• Start date: April 2011
• Est. completion date: February 2014

Study information

• Verified date: October 2011
• Source: Radboud University
• Contact: H.W.M. van Laarhoven, Md
• Phone: +31 24 361 03 53
• Email: h.vanlaarhoven[@]onco.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• BRCA Mutation
• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• individual consult
regular individual consultations
• group medical consult
group medical consult

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.	No