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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Mindfulness
• Intervention / Treatment: Behavioral: Mindfulness Arm; Other: Control group placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Endeavor Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. AJCC Stage IV breast cancer
2. Unwilling to fill out surveys for the study
3. Patients with a distant recurrence
4. Patients unaware of their diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Arm; Brief video and audio practice of mindfulness	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.
Placebo Comparator: Health Videos - Mike Evans; Brief videos focusing on health and wellness	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Depression	To measure the impact of a mindfulness intervention on patient depression using the [PROMIS Emotional Distress - Depression - Short Form 8a questionnaire - options are Never, Rarely, Sometimes, Often, Always].	3 months
Psychosocial wellbeing	To compare psychosocial wellbeing as it pertains to body image between those receiving a mindfulness intervention or general overall health videos, by using the Breast Q questionnaire - answer options are: None of the time, A little of the time, some of the time, most of the time, and all of the time.	3 months
Stress biomarker	To determine if a mindfulness intervention will impact stress biomarker profiles. Participants will be asked to provide self-collected whole dried blood spots to assess IL-6, CRP, and TNF-α using a minimally invasive finger skin prick technique, which involves pricking the finger with a lancet, milking the finger to produce 5 drops of blood onto filter paper, allowing the blood spots to dry, and mailing it to the study team at MGH in a secure envelope.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory	To determine if a mindfulness intervention will impact patient fear of recurrence, using a fear of recurrence questionnaire - answer options are strongly disagree, disagree, not certain, agree, strongly agree.	3 months
Self-Kindness questionnaire	To measure patient self- compassion and kindness. using a (Self-Compassion Scale-5 items- answer choices are: Almost Never, Never, Sometimes, Always, Almost Always)	3 months
Emotional Reactivity/Regulation and Mindfulness Awareness	Patients will complete the Nonreactivity scale (Five Facet Mindfulness Questionnaire-7 items - answer choices are: Never or very rarely true, Rarely true, Sometimes true, Often true, and Very often true or always true).	3 months

Collaborators and Investigators

• Sponsor: Endeavor Health
• Investigators: Principal Investigator: Katharine Yao, M.D, Endeavor Health

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: October 21, 2025
• First Submitted That Met QC Criteria: October 23, 2025
• First Posted (Estimated): October 27, 2025

Study Record Updates

• Last Update Posted (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: October 23, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; Mindfulness; Cancer Surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: EH20-134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No