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New treatment option for Breast Cancer
Official title E-Mindfulness Approaches for Living After Breast Cancer
ClinicalTrials.gov ID: NCT06748222
What this study is testing
- What it's testing
- NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and/or chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated...
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Fort Smith, Arkansas, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Antioch, California, United States
- Bakersfield, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Cameron Park, California, United States
- Chico, California, United States
- Costa Mesa, California, United States
- Dublin, California, United States
- Fontana, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Harbor City, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Marysville, California, United States
+ 288 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Fort Smith, Arkansas, United States; Jonesboro, Arkansas, United States; Little Rock, Arkansas, United States; Anaheim, California, United States; Antioch, California, United States and 302 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.