E-Mindfulness Approaches for Living After Breast Cancer (HEAL-ABC)

NRG Oncology

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer; Depression

Treatments: Behavioral: Meditation Only Control Group; Behavioral: Mindfulness (MAPs) Digital App; Behavioral: Mindfulness (MAPs) Live Online

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06748222

NCI-2024-10767 (Other Identifier)

NRG-CC015

UG1CA189867 (U.S. NIH Grant/Contract)

R01CA282416-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full description

The goal of this trial is to determine if a digital mindfulness meditation-based intervention program can improve the mental health and well-being among younger breast cancer survivors with elevated symptoms of depression. Mindfulness meditation programs provided in person have been shown to be helpful for younger breast cancer survivors. This study will compare different digital approaches for mindfulness training to see which is the most effective.

This study will also explore mediators and moderators of intervention effects, which is key for efficiently targeting psychological resources in the oncology setting and may be particularly relevant for deciding between digital intervention approaches for individual patients. Research on moderators of in-person mindfulness-based interventions (MBIs) in cancer populations suggests that patients with worse psychological functioning at study entry tend to benefit more from these interventions, with mixed effects for other predictors. It is unclear whether more distressed patients will show similar benefits in digital interventions that lack in-person check-ins and monitoring by instructors. Thus, investigators will assess baseline distress along with key demographic characteristics and social determinants of health (e.g., race, ethnicity, education, rurality) as potential moderators. With respect to mediators, emotion regulation strategies including rumination and self-kindness have been shown to mediate effects of in-person MBIs on stress and depression in cancer populations, consistent with the broader theoretical and empirical literature on mindfulness. Determining whether these factors predict and explain effects of digital MBIs, and whether these effects differ by delivery mode, is necessary for achieving optimal outcomes of these interventions. Further, investigators will collect information on the cost-effectiveness of these programs, which is critical for payors to make coverage decisions, healthcare providers and employers to make adoption decisions, and patients to make participation decisions.

Enrollment: 402 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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402 participants in 3 patient groups

Mindfulness (MAPs) Live Online

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness (MAPs) Live Online

Mindfulness (MAPs) Digital App

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness (MAPs) Digital App

Meditation Only Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Meditation Only Control Group