E-Mindfulness Approaches for Living After Breast Cancer

Official title

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

Overview

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.

Detailed 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.

Interventions

• Behavioral Mindfulness (MAPs) Live Online
  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 daily and increasing to 20 minutes daily using guided meditations. Attendance in the group sessions and home practice will be tracked to determine "dose" of the intervention
• Behavioral Mindfulness (MAPs) Digital App
  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 intervention received.
• Behavioral Meditation Only Control Group
  Use of the meditations will be tracked to determine "dose" of the intervention received.

Primary outcome measures

• Self-reported depressive symptoms measured-post intervention in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups [Time frame: 2 weeks post-intervention]
• Self-reported depressive symptoms measured-post intervention in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups [Time frame: 2 weeks post-intervention]

Secondary outcome measures (4)

• Self-reported depressive symptoms in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups over time. [Time frame: 3-6 months post-intervention]
• Self-reported depressive symptoms in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups over time. [Time frame: 3-6 months post-intervention]
• Self-reported fatigue symptoms in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups. [Time frame: 6 months post-intervention]
• Self-reported fatigue symptoms in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups. [Time frame: 6 months post-intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 381 centers

• Mayo Clinic Hospital in Arizona — Phoenix
• Mercy Hospital Fort Smith — Fort Smith
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro
• University of Arkansas for Medical Sciences — Little Rock
• Kaiser Permanente-Anaheim — Anaheim
• Kaiser Permanente-Deer Valley Medical Center — Antioch
• AIS Cancer Center at San Joaquin Community Hospital — Bakersfield
• Kaiser Permanente-Baldwin Park — Baldwin Park
• … and 373 more centers

Puerto Rico · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06748222 · NRG-CC015 · R01CA282416-01 · UG1CA189867 · NCI-2024-10767

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗