Patient Empowerment by Group Medical Consultations (GMC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01329068
First received: March 31, 2011
Last updated: January 19, 2012
Last verified: October 2011
  Purpose

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.


Condition Intervention
Breast Cancer
BRCA Mutation
Behavioral: individual consult
Behavioral: group medical consult

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Patient Empowerment by Group Medical Consultations in the Follow-up of Breast Cancer Survivors and Surveillance of Women With a BRCA Mutation

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 320
Study Start Date: April 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329068

Contacts
Contact: H.W.M. van Laarhoven, Md +31 24 361 03 53 h.vanlaarhoven@onco.umcn.nl
Contact: A. Visser +31 24 361 03 54 a.visser@onco.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Principal Investigator: H.W.M. van Laarhoven, Md         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: H.W.M. van Laarhoven, Md PhD Radboud University
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01329068     History of Changes
Other Study ID Numbers: UMCNONCO201006
Study First Received: March 31, 2011
Last Updated: January 19, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 14, 2014