Clinical trial · Interventional
Supporting Women With Breast Cancer to Prepare for Treatment (The Prepare Study)
NCT07221071CI-TRIAL-00096799PreparecompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mindfulness | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group placebo | Other | — | UNRESOLVED |
| Mindfulness Arm | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mindfulness Arm
- description
- Brief video and audio practice of mindfulness
- interventionNames
- Behavioral: Mindfulness Arm
- type
- PLACEBO_COMPARATOR
- label
- Health Videos - Mike Evans
- description
- Brief videos focusing on health and wellness
- interventionNames
- Other: Control group placebo
Primary outcomes (1)
- measure
- Patient Anxiety
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDBlack 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
- BACKGROUNDBishop SR, Lau M, Shapiro S, et al. Mindfulness: A Proposed Ooperational Definition. Clinical Psychology: Science and Practice. 2004;11(3):230-241