This phase 3 trial aims to evaluate the effectiveness of mindfulness meditation or survivorship education in improving behavioral symptoms in younger stage 0-III breast cancer survivors. The main outcome to be investigated is the change in depressive symptoms. This trial is taking place in the states of California, Maryland and Massachusetts in the United States.
The details
Mindfulness mediation is a behavioral therapy. It aims to make patients more aware of their surroundings and teaches them how to react differently to stress triggers. Survivorship education is also a behavioral therapy. It aims to reduce stress and improve the overall well-being and quality of life for patients. It is thought that mindfulness meditation or survivorship education may improve the quality of life for younger breast cancer survivors.
The study will evaluate the effectiveness of mindfulness mediation and survivorship education in reducing depressive symptoms by measuring depressive symptoms.
Who are they looking for?
This study will recruit 360 women with stage 0 to 3 breast cancer and mild clinical depression. Eligible patients must have received diagnosis prior to age 45 and have been diagnosed in the last 5 years. Patients should be finished all surgery, radiation and chemotherapy 6 months before the trial. Those who are still on trastuzumab or hormone therapy can take part.
Patients who have breast cancer recurrence, metastasis (stage 4) or any other cancer will be excluded. Patients who already practice mindfulness meditation will be excluded from this trial. Those with other serious medical conditions or psychological conditions will not be eligible.
How will it work
Patients will be randomly divided into three groups. Group A will attend a mindfulness meditation class over 2 hours once a week for 6 weeks. After this period patients will attend further sessions on how to maintain mindfulness over 1 hour once a month for 2 months. Group B will attend a survivorship education class over 2 hours once a week for 6 weeks. This group will also receive emails with information about cancer and healthy living. Group C will receive standard care for 9 months and are then given the option of joining group A or B.
The effectiveness of these practices will be measured by rating depressive symptoms on a scoring system 3 and 6 months after participation.
