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

NOT ENROLLING
Protocol # :
16-569
Conditions
Cancer Survivor
Early-Stage Breast Carcinoma
Stage 0 Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Phase
Not Applicable
Disease Sites
Breast
Principal Investigator
Partridge, Ann, H

Trial Description

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.

Eligibility Requirements

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

16-569