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

NCT ID: NCT07221071

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-05
• Study Completion Date: 2024-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindfulness Arm

Brief video and audio practice of mindfulness

Group Type: EXPERIMENTAL

Mindfulness Arm

Intervention Type: 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.

Health Videos - Mike Evans

Brief videos focusing on health and wellness

Group Type: PLACEBO_COMPARATOR

Control group placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Katharine Yao, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katharine Yao, M.D

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

Endeavor Health

Evanston, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26799456 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

EH20-134

Identifier Type: -

Identifier Source: org_study_id