Mindfulness Approaches for Living After Breast Cancer

(HEAL-ABC Trial)

Recruiting at 189 trial locations

Overseen By Director Regulatory Affairs

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: NRG Oncology

Disqualifiers: Recurrent cancer, Other cancer, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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?

This trial explores the effectiveness of different digital mindfulness programs for younger breast cancer survivors experiencing feelings of depression. Participants will engage in either live sessions over Zoom or an app-based program to determine which method better improves mood and mental well-being. It is ideal for those diagnosed with breast cancer by age 50, who completed their main treatments at least six months ago, and who continue to experience depressive symptoms. As an unphased trial, this study provides a unique opportunity to investigate innovative approaches to enhancing mental well-being.

Do I need to stop my current medications to join the trial?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that participants may still be taking certain adjuvant therapies, so it seems likely that you can continue your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mindfulness practices are generally easy for participants to handle. Studies have found that Mindful Awareness Practices (MAPs) can positively impact mental health and boost the immune system in younger breast cancer survivors, offering a promising way to enhance overall well-being.

For the Mindfulness (MAPs) Digital App, research has explored digital health tools and found they benefit breast cancer survivors by helping manage stress and improve mental health.

The Mindfulness (MAPs) Live Online approach also appears promising. Studies suggest that online mindfulness programs can enhance mental health and well-being in cancer patients, proving both practical and effective.

Overall, mindfulness interventions like these are considered safe, with no significant negative effects reported in the studies reviewed. They offer a good option for those looking to support their mental health after breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness Approaches for Living After Breast Cancer because it introduces innovative ways to support survivors through mindfulness, a method that can complement existing treatments like medication and therapy. The MAPs Live Online offers interactive, live sessions that foster community and personal growth, which is different from traditional solitary meditation practices. Meanwhile, the MAPs Digital App makes mindfulness accessible on-the-go, allowing users to integrate short, impactful sessions into their daily routines. These approaches offer flexibility and personalization, potentially enhancing emotional well-being and quality of life for breast cancer survivors in ways that standard treatments might not fully address.

What evidence suggests that these mindfulness approaches could be effective for breast cancer survivors?

Research has shown that online mindfulness programs can reduce anxiety and improve well-being in breast cancer survivors. In this trial, participants will engage in different mindfulness approaches. The Mindful Awareness Practices (MAPs) Live Online sessions have successfully lowered depression and enhanced both physical and mental health. Another group will use the MAPs Digital App, which studies indicate can lead to better mental health outcomes. These approaches hold promise for helping breast cancer survivors manage their mental health after treatment. ^{1 2 6 7 8}

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 can use a smartphone, tablet, or digital device.

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

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12168463/

A Mindfulness Breast Care App to reduce body image distress ... Data from a previous study indicated that a 12-week online MBCT App was enough to improve psychological outcomes [36]. Thus, consensus was ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S235201322500050X

A Mindfulness Breast Care App to reduce body image ... Data from a previous study indicated that a 12-week online MBCT App was enough to improve psychological outcomes [36]. Thus, consensus was reached among the ...

3. ascopubs.org ascopubs.org/doi/10.1200/CCI.24.00014

Mapping the Evidence on the Impact of mHealth ... Digitally capturing these outcomes offers several advantages, such as enhanced patient acceptance and time efficiency, reduced costs, improved ...

4. nature.com nature.com/articles/s41598-025-22889-0

Testing two digital stress-management interventions in a ... Mindfulness-based interventions for psychological and physical health outcomes in cancer patients and survivors: A systematic review and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7248798/

A Smartphone App–Based Mindfulness Intervention for ... This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12242455/

Evidence-based digital health interventions for breast ... We conducted an umbrella review to summarize the evidence on digital health interventions aimed at improving health-related outcomes for BCS.

7. formative.jmir.org formative.jmir.org/2023/1/e48719

Digital Cognitive Behavioral- and Mindfulness-Based Stress ... This study shows how theory specific digital stress-management interventions for survivors of breast cancer can be developed combining existing ...

8. teams.semel.ucla.edu teams.semel.ucla.edu/cousins/mindful-awareness-practices-maps-research

Mindful Awareness Practices (MAPs) Research MAPs had beneficial effects on psychological and immune outcomes in younger breast cancer survivors and is a promising approach for enhancing biobehavioral ...