RecruitingPhase 3

E-Mindfulness Approaches for Living After Breast Cancer

Harnessing E-Mindfulness Approaches for Living After Breast Cancer-HEAL-ABC

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two online mindfulness programs: live classes on Zoom and a self-paced app. Mindfulness means practicing paying attention to the present moment. The study is for younger breast cancer survivors who have finished their main treatment and have symptoms of depression.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Were diagnosed with breast cancer between ages 18 and 50 and were assigned female at birth.
  • Had a first breast cancer diagnosis of stage 0, I, II, or III, with no spread to distant parts of the body.
  • Score 5 to 14 on the PHQ-8, an 8-question survey about depression symptoms.
  • Finished all main breast cancer treatments 6 months to 5 years before joining. You may still take trastuzumab or hormone therapy, or finish minor breast reconstruction surgery.
  • Can understand, speak, read, and write in English or Spanish.
  • Are willing to join a 6-week mindfulness training program.
  • Can use a smartphone, tablet, or another digital device.
  • You or your legal representative must give consent before study entry. U.S. participants must also allow the release of personal health information.

Who can't join

  • Score below 5 or above 14 on the PHQ-8 depression survey.
  • Have or have ever had breast cancer that came back or spread to distant parts of the body.
  • Have or have had another cancer. Exceptions are non-melanoma skin cancer or in situ cervical cancer, which stays where it started, if treated without chemotherapy.
  • Are pregnant or plan to become pregnant soon.
  • Are in another cancer control or behavior-change study that requires frequent check-ins or training.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (381)

AR

AZ

  • Mayo Clinic Hospital in Arizona · Phoenix, AZ 85054Site Public Contact · Study contact · 855-776-0015Oluwadamilola T. Oladeru · Principal investigatorMore trials in Phoenix

CA

CO

CT

DC

FL

GA

HI

IA

IL

IN

KS

  • Cotton O'Neil Cancer Center / Stormont Vail Health · Topeka, KS 66606Site Public Contact · Study contact · 785-270-4939Mehmood H. Hashmi · Principal investigatorMore trials in Topeka

KY

LA

MA

MD

MI

MN

MO

MS

NC

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NE

NJ

NY

OH

OK

OR

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RI

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SD

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WY