Mindfulness Approaches for Living After Breast Cancer

(HEAL-ABC Trial)

Overseen By Director Regulatory Affairs

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: NRG Oncology

Disqualifiers: Recurrent cancer, Other cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

402 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for female breast cancer survivors who were diagnosed at or before age 50, have finished primary treatment between 6 months and 5 years ago, and are experiencing some depression. They must score within a specific range on a depression questionnaire, be able to use digital devices, understand English or Spanish, and consent to participate in a mindfulness program.

Inclusion Criteria

I or my legal representative have given consent and allowed my health information to be shared.

I am willing to join a 6-week mindfulness training program.

I can use a smartphone, tablet, or digital device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in mindfulness-based interventions either through live online sessions or a digital app over a 6-week period

6 weeks

6 visits (virtual for live online sessions)

Post-intervention Assessment

Participants' depressive symptoms are assessed using the CES-D score 2 weeks after the intervention

2 weeks

Follow-up

Participants are monitored for depressive and fatigue symptoms over time

3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness (MAPs) Digital App
• Mindfulness (MAPs) Live Online

Trial Overview The study compares two ways of delivering mindfulness training: one through live online sessions (MAPs LO) via Zoom and the other through a self-paced app (MAPs App). It aims to see which method is more effective for improving mental well-being after breast cancer treatment.

How Is the Trial Designed?

Group I: Mindfulness (MAPs) Live Online Experimental Treatment 1 Intervention

Participants assigned to MAPs Live Online (MAPs LO) will be asked to attend 2-hour group sessions once a week for 6 weeks conducted live online over Zoom. Both English and Spanish language participants will be randomized to Arm 1. Sessions will be conducted on an encrypted internet connection and recorded for quality assurance and intervention fidelity. Participants who do not have a home computer, smartphone, tablet, or internet to access the Zoom sessions will have a tablet and hotspot provided by the UCLA research team. Each session provides structured lessons and guided exercises in mindfulness as well as opportunities for reflection and group discussion. Exercises include breath, body, and sound meditations; eating and walking meditations; managing pain; working with difficult thoughts and emotions; and cultivating loving kindness. Home practice is a key component of MAPs, and participants will be instructed to practice mindfulness techniques daily, beginning with 5 minutes

Group II: Mindfulness (MAPs) Digital App Experimental Treatment 1 Intervention

Participants assigned to this condition will be asked to access the MAPs App on their home computer, smartphone, or study supplied tablet over the 6-week intervention period. This will be provided by the UCLA research team. Only English language speakers will be assigned to Arm 2, as the app is currently available only in English at this time. Participants who do not have a home computer, smartphone, tablet, or internet to access the digital app will be provided with a tablet and hotspot by the UCLA research team. The MAPs App translates the content of the MAPs intervention into an app-based format, with lessons, exercises, and guided discussions from the six 2-hour sessions separated into shorter micro-sessions. The digital program is sequential with new content and exercises building on previous sessions. Lessons and other materials are gradually unlocked as participants progress through the program. Engagement with the MAPs App will be tracked to determine "dose" of the inte

Group III: Meditation Only Control Group Active Control 1 Intervention

The participants assigned to this condition will be provided with access to guided audio mindfulness meditations developed by the UCLA MARC (Mindfulness Awareness Research Center) and available on an app. Both English and Spanish speakers will be assigned to Arm 3, and the meditations will be available in both languages. Participants who do not have a home computer, smartphone, tablet, or internet to access the meditations will be provided with a tablet and hotspot by the UCLA research team. Use of the meditations will be tracked to determine "dose" of the intervention received. All three study groups will have access to the UCLA MARC mindfulness meditation app throughout the study duration out to 6 months of follow-up.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+