Clinical trial · Interventional
The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer
- 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)
In this study the investigators propose to pilot test a brief, mindfulness shared decision making intervention that begins shortly after receiving a diagnosis of breast cancer. A mindfulness instructor will conduct an hour long session with consented participants before the scheduled surgical appointment. The investigators hypothesize that a mindfulness intervention delivered shortly after receiving a diagnosis of breast cancer may ultimately lead to increased decisional satisfaction and alignment to participant's values and preferences, and decreased anxiety. To measure this endpoint, participants will complete three surveys via REDCap- at baseline, before surgery, and 6 months postoperatively. Surveys will include questions on quality of life, anxiety, and participant satisfaction with the mindfulness program.
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 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mindfulness Session | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mindfulness Intervention
- description
- Newly diagnosed breast cancer patients who undergo a mindfulness session before their surgical appointment.
- interventionNames
- Behavioral: Mindfulness Session
Primary outcomes (8)
- measure
- Acceptability of a mindfulness intervention prior to the surgical consultation measured by adherence to the intervention.
- timeFrame
- 1 year
- description
- The number of patients who have successfully completed their mindfulness session with the mindfulness instructor. Zero being not one completion, twenty-five being all have completed the mindfulness session.
- measure
- Acceptability of a mindfulness intervention following the surgical consultation measured by adherence to the follow up session.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Females \>20 and \< 70 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)
- BACKGROUNDYao K, Belkora J, Bedrosian I, Rosenberg S, Sisco M, Barrera E, Kyrillios A, Tilburt J, Wang C, Rabbitt S, Pesce C, Simovic S, Winchester DJ, Sepucha K. Impact of an In-visit Decision Aid on Patient Knowledge about Contralateral Prophylactic Mastectomy: A Pilot Study. Ann Surg Oncol. 2017 Jan;24(1):91-99. doi: 10.1245/s10434-016-5556-x. Epub 2016 Sep 21. PMID 27654108
- BACKGROUNDSepucha K, Ozanne E, Silvia K, Partridge A, Mulley AG Jr. An approach to measuring the quality of breast cancer decisions. Patient Educ Couns. 2007 Feb;65(2):261-9. doi: 10.1016/j.pec.2006.08.007. Epub 2006 Oct 4. PMID 17023138