IA Trial Radar | ||
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O estudo clínico NCT06748222 (HEAL-ABC) para Câncer de mama, Depressão está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
E-Mindfulness Approaches for Living After Breast Cancer (HEAL-ABC)
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.
Harnessing E-Mindfulness Approaches for Living After Breast Cancer-HEAL-ABC
- HEAL-ABC
- NRG-CC015
- R01CA282416-01 (Subvenção/Contrato NIH (EUA))
- UG1CA189867 (Subvenção/Contrato NIH (EUA))
- NCI-2024-10767 (Outro identificador) (NCI)
Mindfulness
Meditation
Digital
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalMindfulness (MAPs) Live Online 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 | 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 received. |
ExperimentalMindfulness (MAPs) Digital App 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 | 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. |
Comparador ativoMeditation Only Control Group 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. | Meditation ONLY Control Group Use of the meditations will be tracked to determine "dose" of the intervention received. |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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. | 2 weeks post-intervention |
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. | 2 weeks post-intervention |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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. | 3-6 months post-intervention |
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. | 3-6 months post-intervention |
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. | 6 months post-intervention |
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. | 6 months post-intervention |
- 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.
- 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.
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