E-Mindfulness Approaches for Living After Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-50
SponsorNRG Oncology
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness (MAPs) Live Online
BehavioralExercises 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 received.
Mindfulness (MAPs) Digital App
BehavioralThe 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.
Meditation Only Control Group
BehavioralUse of the meditations will be tracked to determine "dose" of the intervention received.
Treatment groups
402 Participants
are divided into 3 treatment groupsGroup A: Mindfulness (MAPs) Live OnlineExperimental treatment 1 intervention
Group B: Mindfulness (MAPs) Digital AppExperimental treatment 1 intervention
Group C: Meditation Only Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Self-reported depressive symptoms measured-post intervention in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups
The Center for Epidemiologic Studies-Depression (CES-D) score. The score is calculated as the sum of the points for all 10 items. The score range is 0-30 and a score of 10 or greater is considered depressed.
Time frame
2 weeks post-intervention2
Self-reported depressive symptoms measured-post intervention in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups
The Center for Epidemiologic Studies-Depression (CES-D) score. The score is calculated as the sum of the points for all 10 items. The score range is 0-30 and a score of 10 or greater is considered depressed.
Time frame
2 weeks post-interventionSecondary outcomes
1
Self-reported depressive symptoms in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups over time.
The Center for Epidemiologic Studies-Depression (CES-D) score. The score is calculated as the sum of the points for all 10 items. The score range is 0-30 and a score of 10 or greater is considered depressed.
Time frame
3-6 months post-intervention2
Self-reported depressive symptoms in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups over time.
The Center for Epidemiologic Studies-Depression (CES-D) score. The score is calculated as the sum of the points for all 10 items. The score range is 0-30 and a score of 10 or greater is considered depressed.
Time frame
3-6 months post-intervention3
Self-reported fatigue symptoms in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups.
The Patient-Reported Outcomes Measurement Information System-Short Form-Fatigue (PROMIS SF v1.0-Fatigue 7a) score. The score is calculated as the sum of the values of the response to each question (range 7-35), then rescaled into a standardized T-score with a mean of 50 and standard deviation of 10. Higher scores indicate worse fatigue than average.
Time frame
6 months post-intervention4
Self-reported fatigue symptoms in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups.
The Patient-Reported Outcomes Measurement Information System-Short Form-Fatigue (PROMIS SF v1.0-Fatigue 7a) score. The score is calculated as the sum of the values of the response to each question (range 7-35), then rescaled into a standardized T-score with a mean of 50 and standard deviation of 10. Higher scores indicate worse fatigue than average.
Time frame
6 months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
NRG Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov