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

NCT07221071 | Completed

• 1 other identifier: EH20-134
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Mindfulness

Keywords

Cancer Surgery; Mindfulness; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Patient Anxiety

  To measure the impact of a mindfulness intervention instituted prior to surgery on patient anxiety for newly diagnosed breast cancer patients, using the PROMIS anxiety questionnaire \[Emotional Distress - Anxiety - Short Form 8a answer options are: Never, Rarely, Sometimes, Often, Always\].

  3 months

Secondary Outcomes (3)

• Patient Depression

  3 months

• Psychosocial wellbeing

  3 months

• Stress biomarker

  3 months

Other Outcomes (3)

• Exploratory

  3 months

• Self-Kindness questionnaire

  3 months

• Emotional Reactivity/Regulation and Mindfulness Awareness

  3 months

Study Arms (2)

Mindfulness Arm

EXPERIMENTAL

Brief video and audio practice of mindfulness

Behavioral: Mindfulness Arm

Health Videos - Mike Evans

PLACEBO COMPARATOR

Brief videos focusing on health and wellness

Other: Control group placebo

Interventions

Mindfulness Arm BEHAVIORAL

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.

Mindfulness Arm

Control group placebo OTHER

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.

Health Videos - Mike Evans

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females \>20 and \< 85 years of age
• History of contralateral breast cancer in the past is acceptable
• Patients seeking second opinion for diagnosis are eligible
• Clinical AJCC stage 0-III breast cancer
• Patients who have an in breast tumor recurrence are eligible
• English Speaking
• Willing to fill out surveys required for the study
• Gene mutation carriers are eligible
• Neoadjuvant therapy patients are eligible

You may not qualify if:

• AJCC Stage IV breast cancer
• Unwilling to fill out surveys for the study
• Patients with a distant recurrence
• Patients unaware of their diagnosis

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Endeavor Health

Evanston, Illinois, 60201, United States

Location

Related Publications (2)

• Black DS, Slavich GM. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.

  PMID: 26799456 BACKGROUND

• Bishop SR, Lau M, Shapiro S, et al. Mindfulness: A Proposed Ooperational Definition. Clinical Psychology: Science and Practice. 2004;11(3):230-241

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Katharine Yao, M.D

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 27, 2025
• Study Start: August 5, 2021
• Primary Completion: August 1, 2023
• Study Completion: December 31, 2024
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)