Patient Empowerment by Group Medical Consultations in the Follow-up of Breast Cancer Survivors and Surveillance of Women With a BRCA Mutation
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, BRCA Mutation
Female
Breast Cancer, BRCA Mutation
Trial Information
Patient Empowerment by Group Medical Consultations in the Follow-up of Breast Cancer Survivors and Surveillance of Women With a BRCA Mutation
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Psychological distress (SCL-90) and empowerment (Cancer Empowerment Questionnaire)
Outcome Time Frame:
BRCA mutation carriers: Baseline (1 week before the (group) medical visit) and 1 week and three months after the (group) medical visit.
Safety Issue:
No
Principal Investigator
H.W.M. van Laarhoven, Md PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radboud University
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
UMCNONCO201006
NCT ID:
NCT01329068
Start Date:
April 2011
Completion Date:
February 2014
Related Keywords:
- Breast Cancer
- BRCA Mutation
- breast cancer
- Breast Neoplasms
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