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A Study to Examine Mindfulness Training to Improve Mental Health and Well-being in Younger Breast Cancer Survivors, HEAL-ABC Trial
Trial Status: active
This clinical trial compares the effect of a live instructor led version of the mindfulness meditation-based intervention, Mindful Awareness Practices (MAPs) and MAPs application (App)-based, self-directed version to guided audio meditation alone on mental health and well-being in younger patients with stage 0-III breast cancer. Many women diagnosed with breast cancer under the age of 50 report significant fatigue, sleep problems and menopausal symptoms which can have a negative effect on mental health and well-being. Behavioral interventions, such as mindful meditation, uses techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Mindful meditation involves guided sessions designed to improve psychological well-being through reduced anxiety, depressive symptoms, distress, and improved mood. Mindfulness meditation programs provided in-person have been shown to be helpful, however, many may not be able to travel to locations for in-person sessions. Online live MAPs sessions provide the opportunity for patients to interact with the instructor and peers in much the same way as in-person sessions. However, live class schedules may not be feasible for many women who are busy with work, family responsibilities or their own needs. A self-directed app version of MAPS may improve accessibility to meditation practices. Live instructor led MAPs and self-directed MAPs App may be more effective in improving mental health and well-being compared to guided audio meditation alone in younger patients with stage 0-III breast cancer.
Inclusion Criteria
The participant must provide study-specific informed consent prior to registration and, for participants treated in the United States (U.S.), authorization permitting release of personal health information
The participant must have been ≥ 18 and < 51 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 ≥ 5 and ≤ 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., poly [ADP-ribose] polymerase [PARP] inhibitors, CDK4/6 inhibitors, trastuzumab emtansine [TDM-1], pertuzumab, or immunotherapy). Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery
The 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 < 5 or > 14
Any history or current evidence of recurrent or metastatic breast cancer
Current or past history of another cancers. 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
Additional locations may be listed on ClinicalTrials.gov for NCT06748222.
I. To determine the efficacy of Mindful Awareness Practices (MAPs) live online (LO) relative to the meditation only (MO) control group on depressive symptoms, as indicated by the difference in Center for Epidemiologic Studies – Depression (CES-D) change score from baseline to post-intervention between the intervention and control groups.
II. To determine the efficacy of Mindful Awareness Practices (MAPs) App relative to the meditation only (MO) control group on depressive symptoms, as indicated by the difference in CES-D change score from baseline to post-intervention between the intervention and control groups.
SECONDARY OBJECTIVES:
I. To determine the persistence of MAPs LO and MAPs App effects on depressive symptoms from baseline to 3-month and 6-month follow-up relative to the MO control group.
II. To determine the efficacy of MAPs LO and MAPs App relative to the MO control group on fatigue, sleep disturbance, vasomotor symptoms, fear of recurrence, well-being, and work productivity.
III. To assess the cost effectiveness of MAPs LO and MAPs App relative to the MO control group.
EXPLORATORY OBJECTIVE:
I. To explore potential mediators and moderators of intervention effects, including rumination and self-kindness (mediators), and baseline depressive symptoms, demographics, and social determinants of health (moderators).
OUTLINE: English speaking patients are randomized to 1 of 3 arms. Spanish speaking patients are randomized to arm 1 or 3.
ARM 1 (MAPs LO): Patients attend online zoom group sessions over 2 hours once weekly (QW) for 6 weeks. Patients practice mindfulness techniques using guided meditations over 5-20 minutes once daily (QD).
ARM 2 (MAPS DIGITAL APP): Patients access MAPs App over up to 3 hours QW for 6 weeks.
ARM 3 (MO CONTROL GROUP): Patients receive access to guided audio mindfulness meditations on study.
After completion of study intervention, patients are followed for up to 6 months.