Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)



Status:Recruiting
Conditions:Breast Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 49
Updated:3/1/2019
Start Date:February 20, 2017
End Date:March 1, 2021

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Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors

This randomized phase III trial studies how well mindfulness meditation or survivorship
education work in improving behavioral symptoms in younger stage 0-III breast cancer
survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help
patients change the way they react to environmental triggers that may cause a negative
reaction. Survivorship education after treatment may reduce stress and improve the well-being
and quality of life of patients with breast cancer. Mindfulness meditation or survivorship
education may help improve the health behaviors of younger breast cancer survivors.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of two different types of group interventions (mindfulness and
survivorship education), specifically tailored to the needs of younger female breast cancer
survivors, in reducing depressive symptoms, compared to a usual care control group.

SECONDARY OBJECTIVES:

I. To compare the efficacy of the two interventions relative to a usual care control group on
fatigue, sleep disturbance, and vasomotor symptoms.

II. To examine the efficacy of the two interventions relative to a usual care control group
on circulating and genomic markers of inflammation.

III. To explore potential moderators and mediators of intervention efficacy in the two
intervention groups.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM A (MINDFULNESS AWARENESS PRACTICES [MAPs]): Patients attend a mindfulness meditation
class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions
that include guided meditation, questions, and discussion of how to maintain a mindfulness
practice over 1 hour once monthly for 3 months.

ARM B (SURVIVORSHIP EDUCATION INTERVENTION [SE]): Patients attend a survivorship education
class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic
newsletters with tailored information about topics of interest to younger survivors,
including cancer-related events in the community and tips about following through on
recommendations for healthy living.

ARM C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP): Patients receive usual care for 9 months.
Patients are then offered a choice of participating in Arm A or Arm B.

After completion of study, patients are followed up at 3 and 6 months.

Inclusion Criteria:

- Women diagnosed with early stage, resectable breast cancer (Stage 0, I, II, or III)
prior to age 50, and are within 5 years of diagnosis

- Have completed all surgery, radiation, and/or chemotherapy treatments at least 6
months previously; may still be receiving trastuzumab or endocrine adjuvant therapy

- Ability to complete evaluation surveys in English

- Have evidence of at least mild clinical depression on a standardized screening
questionnaire

Exclusion Criteria:

- Has a breast cancer recurrence, metastasis, or another interval cancer diagnosis
following the breast cancer (excluding non-melanoma skin cancer)

- Unable to commit to intervention schedule (6 weekly group meetings)

- Actively practicing mindfulness meditation

- Has another serious or chronic medical or psychiatric condition that contributes to
substantial physical or emotional disability that would detract from participating in
either of the intervention programs or from the measurement of intervention outcomes
We found this trial at
3
sites
401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Antonio C. Wolff
Phone: 410-614-4192
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Ann H. Partridge
Phone: 617-632-6081
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Los Angeles, California 90095
Principal Investigator: Patricia A. Ganz
Phone: 310-206-1404
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Los Angeles, CA
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