Breast Neoplasm Clinical Trial
Official title:
GenetiKiT: Evaluation of the Impact of a Multifaceted Intervention to Enhance the Delivery of Genetics Services by Family Physicians.
There is an urgent need for a knowledge translation strategy to facilitate the integration
of genetics into family medicine, to improve the low knowledge base of most Canadian family
physicians, ensure that the needs are met of those in the population who could benefit from
genetic assessment, and facilitate evidence-based decision-making in the face of increasing
patient demand.
We have developed a multi-faceted intervention incorporating three distinct knowledge
translation strategies: interactive educational sessions, a portfolio of tools for use in
clinical practice and an innovative, efficient, information technology-based knowledge
service designed to provide timely ("just-in-time") information which reflects both topical
genetics issues and the pattern of users' queries (a so-called "push-pull" approach).
We hypothesize that a multi-faceted knowledge translation intervention will improve the
delivery of genetics services by family physicians.
The intervention will be evaluated using a randomized controlled trial, in which family
physicians will be allocated to receive the active or control interventions, with
pre-intervention data collected 1 month prior, and post-intervention outcome data 6 months
following the intervention.
A list of practicing family physicians will be obtained from the chiefs of Family Medicine
at local hospitals in Toronto, Ottawa, Timmins, and Thunder Bay. We will develop a sampling
frame for each site reflecting the proportion of solo and group practitioners in the
community. A statistician independent of the study will generate a random number sequence to
allocate practitioners to the control or intervention groups. There is a potential danger of
contamination if two family physicians are recruited from the same group practice and
randomized to different study arms, therefore only one physician per practice will be
invited to participate in the study. Once one family physician has been recruited from a
practice, all other physicians from the same practice will be deleted from the sampling
frame.
Our intervention has three components: an interactive educational workshop, a portfolio of
tools for family physicians to use in their day to day clinical practice, and a new IT-based
knowledge service.
The workshop will deal with practical medical genetics knowledge, risks, benefits and
limitations of genetic testing including psychosocial risks, confidentiality and insurance
issues as well as a critical appraisal framework by which to assess genetic tests. The
workshop will be 60 minutes in length and offered at several times and dates to facilitate
attendance. The College of Family Physicians of Canada educational credit of 1 hour is
available for participation in this project.
Several tools will be presented at the workshop:
A) A family history tool B) Genetics Pearls C) Physician risk triage and management cards
for familial cancer covering risk assessment and management of hereditary breast and
colorectal cancer.
D) A table outlining the possible consequences of genetic test results E) Patient
information aids to help patients self-identify their risk of hereditary cancer F)
GeneMessenger is designed primarily to address knowledge gaps about specific genetics issues
in the news, about which family physicians may feel ill-equipped to form confident opinions.
The research team will scan the mainstream print media for headlines or stories that relate
to medical genetics discoveries or topics. Supported by a geneticist and an expert family
physician, a genetic counselor will appraise the discoveries, tests or interventions for
their relevance to family practice. She will prepare a definitive short review for
participants within 1-2 weeks, but, where appropriate and possible, will prepare a
preliminary comment for rapid communication within 1-2 days. Communication will be by email
or fax as chosen by the participant. Family physicians will be able to contact the service
to suggest questions or topics they would like to see addressed. This service will not
provide professional advice on specific cases or patients and referrals to genetics clinics
would continue in the usual fashion. Physicians would be free to seek telephone advice from
geneticists or counselors regarding specific patients but these would not be addressed as
part of this service.
Data will be collected one month before and six months after the intervention by postal
survey to the participating physicians. Changes in intention to refer to genetics services
in response to 10 clinical vignettes will be compared between the control and intervention
group.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03273426 -
Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.
|
N/A | |
Recruiting |
NCT04583124 -
Adjusting the Dose of Therapeutic Exercise to Prevent Neurotoxicity Due to Anticancer Treatment (ATENTO)
|
N/A | |
Active, not recruiting |
NCT04489173 -
TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer
|
Phase 2 | |
Recruiting |
NCT02913573 -
Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction
|
Phase 2 | |
Completed |
NCT03124095 -
Combined Training Intervention for Women Who Underwent Primary Treatment for Breast Cancer
|
N/A | |
Terminated |
NCT00251095 -
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
|
Phase 3 | |
Completed |
NCT05576545 -
Develop and Evaluate the Effectiveness of a Self-Care Smartphone Application on the Self-Efficacy, and Resilience Among Newly Diagnosed Breast Cancer Patients Undergoing Treatment
|
N/A | |
Active, not recruiting |
NCT03625635 -
Effect of a Clinical Nutrition Intervention Program in Breast Cancer Patients During Antineoplastic Treatment
|
N/A | |
Recruiting |
NCT04799535 -
Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
|
||
Withdrawn |
NCT03266562 -
Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography
|
N/A | |
Completed |
NCT00530868 -
Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer
|
Phase 2 | |
Recruiting |
NCT06255808 -
Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor
|
||
Completed |
NCT04640220 -
Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors
|
N/A | |
Completed |
NCT02970682 -
SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT02316561 -
Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer
|
N/A | |
Terminated |
NCT00638963 -
Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2)
|
Phase 2 | |
Terminated |
NCT00249301 -
A Study of MLN8054 in Patients With Advanced Solid Tumors
|
Phase 1 | |
Not yet recruiting |
NCT06056414 -
Study of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation
|
N/A | |
Recruiting |
NCT05427071 -
Magnetic Marker Localization for Occult Breast Cancer and Target Axillary Dissection in Node-positive Breast Cancer Post-neoadjuvant Chemotherapy
|
N/A | |
Recruiting |
NCT03740893 -
PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition and/or Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Chemotherapy Resistant Residual Triple Negative Breast Cancer
|
Phase 2 |