Brief Summary
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.
Brief Title
E-Mindfulness Approaches for Living After Breast Cancer
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
412-339-5300
Central Contact Email
langerj@nrgoncology.org
Central Contact Role
Contact
Completion Date
Completion Date Type
Estimated
Conditions
Breast Cancer
Depression
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Breast Cancer
Mindfulness
Meditation
Digital
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
50 Years
Minimum Age
18 Years
NCT Id
NCT06748222
Org Class
Other
Org Full Name
NRG Oncology
Org Study Id
NRG-CC015
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Harnessing E-Mindfulness Approaches for Living After Breast Cancer-HEAL-ABC
Primary Outcomes
Outcome Description
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.
Outcome Measure
Self-reported depressive symptoms measured-post intervention in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups
Outcome Time Frame
2 weeks post-intervention
Outcome Description
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.
Outcome Measure
Self-reported depressive symptoms measured-post intervention in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups
Outcome Time Frame
2 weeks post-intervention
Secondary Ids
Secondary Id
R01CA282416-01
Secondary Id
UG1CA189867
Secondary Id
NCI-2024-10767
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
3-6 months post-intervention
Outcome Measure
Self-reported depressive symptoms in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups over time.
Outcome Description
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.
Outcome Time Frame
3-6 months post-intervention
Outcome Measure
Self-reported depressive symptoms in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups over time.
Outcome Description
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.
Outcome Time Frame
6 months post-intervention
Outcome Measure
Self-reported fatigue symptoms in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups.
Outcome Description
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.
Outcome Time Frame
6 months post-intervention
Outcome Measure
Self-reported fatigue symptoms in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
50
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Della Makower
Investigator Email
DMAKOWER@montefiore.org
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
Montefiore
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Breast Cancer --- BREAST NEOPLASMS
Mental Health & Behavioral Research --- DEPRESSION
Psychiatry & Behavioral Sciences --- DEPRESSION
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Breast Cancer --- BREAST DISEASES
Mental Health & Behavioral Research --- BEHAVIORAL SYMPTOMS
Psychiatry & Behavioral Sciences --- BEHAVIORAL SYMPTOMS
MeSH Terms
BREAST NEOPLASMS
DEPRESSION
NEOPLASMS BY SITE
NEOPLASMS
BREAST DISEASES
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
BEHAVIORAL SYMPTOMS
BEHAVIOR
MINDFULNESS
COGNITIVE BEHAVIORAL THERAPY
BEHAVIOR THERAPY
PSYCHOTHERAPY
BEHAVIORAL DISCIPLINES AND ACTIVITIES