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Completed

NCT Number: NCT07221071

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Mindfulness Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Endeavor Health

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Patient Anxiety

    Time frame: 3 months

    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].

Secondary outcomes

  1. Patient Depression

    Time frame: 3 months

    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].

  2. Psychosocial wellbeing

    Time frame: 3 months

    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. Stress biomarker

    Time frame: 3 months

    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.

Other outcomes

  1. Exploratory

    Time frame: 3 months

    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.

  2. Self-Kindness questionnaire

    Time frame: 3 months

    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. Emotional Reactivity/Regulation and Mindfulness Awareness

    Time frame: 3 months

    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).

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Acronym: Prepare

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 27, 2025
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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