Breast CancerPrepareNCT07221071
Supporting Women With Breast Cancer to Prepare for Treatment (The Prepare Study)
A study testing Mindfulness Arm in people with Breast Cancer and Mindfulness, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Mindfulness
- What is being tested?
- Mindfulness Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Willing to fill out surveys required for the study
- Gene mutation carriers are eligible
- Neoadjuvant therapy patients are eligible
Who cannot join
- AJCC Stage IV breast cancer
- Unwilling to fill out surveys for the study
- Patients with a distant recurrence
- Patients unaware of their diagnosis
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Being tested
- Mindfulness Arm, Control group placebo
- Keywords
- Cancer Surgery, Mindfulness, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness ArmBehavioural
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 placeboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Arm | Experimental | Brief video and audio practice of mindfulness Receives: Behavioral: Mindfulness Arm |
| Health Videos - Mike Evans | Placebo comparator | Brief videos focusing on health and wellness Receives: Other: Control group placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 3 months
Secondary outcomes (3)
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].
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start5 Aug 2021
- Primary completion1 Aug 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katharine Yao, MD, Endeavor Health
- Investigators
- Katharine Yao, M.D, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221071
- Sponsor's protocol ID
- EH20-134
- Acronym
- Prepare
- Status last verified
- Oct 2025
- First submitted
- 21 Oct 2025
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26799456Bishop SR, Lau M, Shapiro S, et al. Mindfulness: A Proposed Ooperational Definition. Clinical Psychology: Science and Practice. 2004;11(3):230-241
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Women With Breast Cancer to Prepare for Treatment (The Prepare Study)
- ClinicalTrials.gov ID
- NCT07221071
- Acronym / sponsor ID
- Prepare / EH20-134
- Conditions
- Breast Cancer, Mindfulness
- Keywords
- Cancer Surgery, Mindfulness, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Arm | Experimental | Behavioral: Mindfulness ArmBrief video and audio practice of mindfulness |
| Health Videos - Mike Evans | Placebo comparator | Other: Control group placeboBrief videos focusing on health and wellness |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- AJCC Stage IV breast cancer
- Unwilling to fill out surveys for the study
- Patients with a distant recurrence
- Patients unaware of their diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness ArmParticipants 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. | Behavioural | Mindfulness Arm |
| Control group placeboParticipants 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. | Other | Health Videos - Mike Evans |
Primary outcome
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].
3 secondary outcomes
Patient Depression
Time frame: 3 months
Psychosocial wellbeing
Time frame: 3 months
Stress biomarker
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Background: PubMed 26799456Black 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.
- BackgroundBishop SR, Lau M, Shapiro S, et al. Mindfulness: A Proposed Ooperational Definition. Clinical Psychology: Science and Practice. 2004;11(3):230-241
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharine Yao, M.D principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Arm in people with Breast Cancer and Mindfulness, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Anxiety (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07221071, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.