E-Mindfulness Approaches for Living After Breast Cancer

Recruiting · NCT06748222 · Interventional (participants receive a specific treatment) · Lead sponsor: NRG Oncology

View the official record on ClinicalTrials.gov →

Interventions studied

Meditation Only Control GroupMindfulness (MAPs) Digital AppMindfulness (MAPs) Live Online

What this trial is about

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.

Who can take part

Age range

18 Years to 50 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 39 US states.

Mayo Clinic Hospital in Arizona - Phoenix, Arizona, United States
Mercy Hospital Fort Smith - Fort Smith, Arkansas, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences - Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim - Anaheim, California, United States
Kaiser Permanente-Deer Valley Medical Center - Antioch, California, United States
AIS Cancer Center at San Joaquin Community Hospital - Bakersfield, California, United States
Kaiser Permanente-Baldwin Park - Baldwin Park, California, United States
Kaiser Permanente-Bellflower - Bellflower, California, United States
Marshall Cancer Center - Cameron Park, California, United States
Enloe Medical Center - Chico, California, United States
UC Irvine Health Cancer Center-Newport - Costa Mesa, California, United States
Kaiser Permanente Dublin - Dublin, California, United States
Kaiser Permanente-Fontana - Fontana, California, United States
Kaiser Permanente-Fremont - Fremont, California, United States
Washington Health - Fremont, California, United States
Kaiser Permanente Fresno Orchard Plaza - Fresno, California, United States
Kaiser Permanente-Fresno - Fresno, California, United States
Kaiser Permanente South Bay - Harbor City, California, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine, California, United States
Kaiser Permanente-Irvine - Irvine, California, United States
Kaiser Permanente Los Angeles Medical Center - Los Angeles, California, United States
Los Angeles General Medical Center - Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center - Los Angeles, California, United States
Kaiser Permanente West Los Angeles - Los Angeles, California, United States
Fremont - Rideout Cancer Center - Marysville, California, United States
Kaiser Permanente- Modesto MOB II - Modesto, California, United States
Kaiser Permanente-Modesto - Modesto, California, United States
Kaiser Permanente-Oakland - Oakland, California, United States
Kaiser Permanente-Ontario - Ontario, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange, California, United States
Kaiser Permanente - Panorama City - Panorama City, California, United States
Eisenhower Medical Center - Rancho Mirage, California, United States
Kaiser Permanente- Marshall Medical Offices - Redwood City, California, United States
Kaiser Permanente-Richmond - Richmond, California, United States
Kaiser Permanente-Riverside - Riverside, California, United States
Kaiser Permanente-Roseville - Roseville, California, United States
Kaiser Permanente Downtown Commons - Sacramento, California, United States
Kaiser Permanente-South Sacramento - Sacramento, California, United States
Salinas Valley Memorial - Salinas, California, United States
Kaiser Permanente-San Diego Zion - San Diego, California, United States
Kaiser Permanente-San Francisco - San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose - San Jose, California, United States
Kaiser Permanente San Leandro - San Leandro, California, United States
Kaiser Permanente-San Marcos - San Marcos, California, United States
Kaiser San Rafael-Gallinas - San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara - Santa Clara, California, United States
USC Norris Santa Clarita Oncology - Santa Clarita, California, United States
Kaiser Permanente-Santa Rosa - Santa Rosa, California, United States
Providence Medical Foundation - Santa Rosa - Santa Rosa, California, United States
Kaiser Permanente-South San Francisco - South San Francisco, California, United States
Kaiser Permanente-Stockton - Stockton, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center - Truckee, California, United States
Kaiser Permanente Medical Center-Vacaville - Vacaville, California, United States
Kaiser Permanente-Vallejo - Vallejo, California, United States
Kaiser Permanente-Walnut Creek - Walnut Creek, California, United States
John Muir Medical Center-Walnut Creek - Walnut Creek, California, United States
Kaiser Permanente-Woodland Hills - Woodland Hills, California, United States
UCI Health - Yorba Linda - Yorba Linda, California, United States
UCHealth University of Colorado Hospital - Aurora, Colorado, United States

Showing 60 of 383 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →