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Title:
Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors. The Pathways to Wellness (PTW) Study
Protocol Number:
J16121
Phase:
Phase III
Physician:
Antonio Wolff
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this study is to determine the effectiveness of two types of group interventions: mindfulness meditation and survivorship education. These interventions are designed specifically for the needs of younger female breast cancer survivors.
Eligibility:
Women diagnosed with early stage breast cancer prior to age 45, and are within 5 years of diagnosis. Must have completed all surgery, radiation, and/or chemotherapy treatments at least 6 months previously but may still be receiving endocrine therapy. Must have the ability to complete evaluation surveys in English. Ability to commit to intervention schedule of 6 weekly group meetings.Women may not be actively practicing mindfulness meditation, have a recurrence, metastasis, or other cancer diagnosis following breast cancer (excluding non-melanoma skin cancer), or have any other serious or chronic medical or psychiatric condition that contributes to substantial physical or emotional disability.
Treatment:
At your first visit, you will be asked to complete an online or paper survey questionnaire that will ask you about demographic characteristics, medical history, cancer history, health behaviors (such as drinking alcohol and exercise), mood, energy, sleep, stress, and physical symptoms. You will also have 3-4 tablespoons of blood drawn to look at differences in immune system functioning. You will then be randomly assigned to mindfulness meditation classes, survivorship education classes, or to the wait-list control group. The classes will be held once a week, for 2 hours, on the Johns Hopkins campus for six weeks. If you are assigned to the wait-list control group, you will be able to select with program you would like to attend after the 6 week classes and follow-up visits are finished. After completing the 6 weeks of classes, you will have a second visit. You will be asked to complete a second survey questionnaire and have another blood draw. About 3 months after your second visit, you will be contacted via e-mail to complete a third survey questionnaire but there is no in person visit. About 6 months after completing the classes, you will be asked to come in for a final visit to complete a fourth survey questionnaire and have blood drawn. Participants in the wait-list control group will remain in contact to schedule your future group participation.
Population:
Adult
Last Update
03/05/2019 05:03 AM