NCT07221071

Supporting Women With Breast Cancer to Prepare for Treatment (The Prepare Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: Female
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate if a brief mindfulness intervention before and after surgery would impact patient emotional wellbeing, quality of life, and biomarkers measured before and after surgery by finger prick collection and surveys.

Detailed description

The purpose of this project is to evaluate a brief, technology-enabled mindfulness intervention before and following breast cancer surgery to determine its impact on emotional wellbeing and biological stress response in breast cancer patients. The investigators will administer self-reported questionnaires of emotional wellbeing and quality of life and collect pro and anti-inflammatory cytokines (CRP and IL-10, respectively) using a minimally invasive finger prick approach. The findings from this study will help establish an evidence base on the efficacy of a brief, technology enabled mindfulness intervention on patient anxiety, wellbeing and biological response. No previous studies have examined the impact of a brief mindfulness training prior to and following surgery on patient wellbeing. The long-term goal is to determine whether brief, technology-enabled mindfulness support can become part of routine preparation for breast cancer surgery.

Conditions

• Breast Cancer
• Mindfulness

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Arm	Participants will be instructed to watch four brief breast cancer specific educational mindfulness videos (within the first week of randomization), listen to guided audio recordings of different mindfulness meditations at least 3 times per week throughout the intervention period (which lasts until the Time 3 Assessment), and complete brief, post-listening written reflections in a journal (NOW reflections) that is provided to them during the intervention period.
OTHER	Control group placebo	Participants will receive brief videos that focuses on general health behaviors. We will utilize the Mike Evans chalkboard videos (https://www.reframehealthlab.com/category/whiteboard-health-videos/) as the control for this group. Participants will view the Mike Evans videos within the first week following randomization. The participants will be assigned to watch 10 videos located on the Group B study website. Topics range from cancer fatigue, healthy eating, benefits of exercise, and the science of happiness.

Timeline

• Start date: 2021-08-05
• Primary completion: 2023-08-01
• Completion: 2024-12-31
• First posted: 2025-10-27
• Last updated: 2025-10-27

Locations

1 site across 1 country: United States