E-Mindfulness Approaches for Living After Breast Cancer

Launched by NRG ONCOLOGY · Dec 19, 2024

Keywords

ClinConnect Summary

The E-Mindfulness Approaches for Living After Breast Cancer trial is designed to help younger breast cancer survivors who are experiencing feelings of depression after their treatment. This study will compare two different ways to learn mindfulness techniques—one with a live instructor over Zoom and the other through a self-paced app. The goal is to see which method is more effective in helping participants manage their emotions and improve their overall well-being.

To be eligible for this trial, participants should be women aged 18 to 50 who were diagnosed with non-metastatic breast cancer and have completed their primary treatment at least six months ago. They should also have mild to moderate depressive symptoms, as measured by a simple questionnaire. If you choose to participate, you can expect to commit to a six-week program where you will learn mindfulness strategies that can help you cope with life's challenges after cancer. It's important to know that this trial is not yet recruiting participants, so keep an eye out for updates if you're interested!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated in the U.S., authorization permitting release of personal health information.
• • The participant must have been greater than or equal to 18 or less than or equal to 50 years of age at the time of breast cancer diagnosis.
• • The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
• • The participant must have a score of greater than or equal to 5 and less than or equal to 14 on the Patient Health Questionnaire-8 item (PHQ-8).
• • Participants must have completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, targeted therapies (e.g., PARP (poly-ADP ribose polymerase) inhibitors, CDK4/6 inhibitors, TDM-1, pertuzumab, or immunotherapy). (Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.)
• • Participant must be able to understand, speak, read, and write in English or Spanish.
• • Participant must be willing to participate in a 6-week program to receive training in mindfulness.
• • Participant must be able to use a smartphone, tablet, or other digital device.
• • Sex assigned at birth must be female.
• Exclusion Criteria:
• • Patient Health Questionnaire-8 item (PHQ-8) score of less than 5 or greater than 14 .
• • Any history or current evidence of recurrent or metastatic breast cancer.
• • Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.
• • Currently pregnant or planning to become pregnant in the near future.
• • Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.