Patient Empowerment by Group Medical Consultations (GMC)

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; BRCA Mutation
• Intervention / Treatment: Behavioral: individual consult; Behavioral: group medical consult

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Recruiting
      • Radboud University Nijmegen Medical Centre
      • Principal Investigator: H.W.M. van Laarhoven, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Individual consult; regular individual consult	Behavioral: individual consult; regular individual consultations
Active Comparator: group medical consult; regular group medical consult	Behavioral: group medical consult; group medical consult

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: H.W.M. van Laarhoven, Md PhD, Radboud University Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: March 31, 2011
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (Estimate): April 5, 2011

Study Record Updates

• Last Update Posted (Estimate): January 20, 2012
• Last Update Submitted That Met QC Criteria: January 19, 2012
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UMCNONCO201006