Trial NCT06748222
E-Mindfulness Approaches for Living After Breast Cancer
- Phase
- Phase 3
- Sponsor
- NRG Oncology
- Conditions
- Breast Cancer; Depression
- Ages
- 18–50 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Age
* 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.Language
* 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.Prior malignancy
* Currently pregnant or planning to become pregnant in the near future.Pregnancy
* Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.
Restrictions found (4)
- AgeOutrightinclusion
age <= 50 at diagnosis
Show in the text - LanguageOutrightinclusionShow in the text
- PregnancyConditionalexclusionShow in the text
- Prior malignancyConditionalexclusionShow in the text
Recruiting in Massachusetts
- Beverly Hospital · Beverly, Essex County
- Tufts Medical Center · Boston, Suffolk County
- Lahey Clinic · Burlington, Middlesex County
- Addison Gilbert Hospital · Gloucester, Essex County
- Lowell General Hospital · Lowell, Middlesex County
- Lahey Clinic Peabody · Peabody, Essex County
- Tufts Medical Center Cancer Center Stoneham · Stoneham, Middlesex County