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Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors (NCT03025139)

National Cancer Institute (NCI)
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.
  • Other: Educational Intervention
    Attend survivorship education
    • Education for Intervention
    • Intervention by Education
    • Intervention through Education
    • Intervention, Educational
  • Other: Laboratory Biomarker Analysis
    Correlative studies
    • Procedure: Meditation Therapy
      Attend mindfulness meditation
      • Meditation
    • Other: Questionnaire Administration
      Ancillary studies
      Ages eligible for Study
      up to 49 Years
      Genders eligible for Study
      Female
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Women diagnosed with early stage, resectable breast cancer (Stage 0, I, II, or III) prior to age 45, 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
      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.

      3 locations

      United States (3)
      • UCLA / Jonsson Comprehensive Cancer Center
        recruiting
        Los Angeles, California, United States, 90095
      • Johns Hopkins University/Sidney Kimmel Cancer Center
        recruiting
        Baltimore, Maryland, United States, 21287
      • Dana-Farber Cancer Institute
        not yet recruiting
        Boston, Massachusetts, United States, 02115
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      19 February, 2017
      Updated:
      20 March, 2017
      Participants:
      360
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