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

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