Clinical trial · Observational
Mental and Cognitive Health and Physical Activity in the Perioperative Breast Cancer Setting
Characterizing Mental and Cognitive Health and Physical Activity in the Perioperative Breast Cancer Setting
- 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)
This study evaluates the complex relationships between mental health, cognitive function, and physical activity before surgery in patients with stage I-III breast cancer. Most patients with breast cancer experience declines in their mental health, with up to two-thirds of patients reporting symptoms of depression and anxiety. Cancer-related cognitive decline is even more prevalent; 75% of patients with breast cancer report varying degree of loss in mental acuity throughout their cancer experience. Both mental and cognitive health declines are pervasive, lasting anywhere from 5 years to decades after treatment completion. Not only are these declines detrimental to patients' quality of life, but they also increase the risk of cancer-related mortality. Maintaining sufficient levels of physical activity (PA) is important to both prevent breast cancer and improve health post-diagnosis. PA improves anxiety and depressive symptoms during and after treatment. Early intervention with PA prior to or during cancer treatment, or prehabilitation, can avoid or reduce the severity of treatment-related side effects, hospital length of stay, surgical complications, and care costs. Information gained in this study may help researchers learn more about the right time during treatment for delivering lifestyle programs to improve mental and cognitive health.
Conditions
Conditions (4)
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 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Actigraph | Other | — | UNRESOLVED |
| BrainBaseline application | Other | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
| Semi-structured interviews | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients
- description
- Participants wear ActiGraphs, complete questionnaires via phone call/text message, and participate in interviews remotely on study.
- interventionNames
- Other: Actigraph
- Other: Questionnaires
- Other: BrainBaseline application
- Other: Semi-structured interviews
- label
- Stakeholders
- description
- Semi-structured interviews will be conducted with up to 15 key stakeholders (e.g., nurse coordinators, surgical and medical oncologists, physical therapists) at Siteman Cancer Center.
- interventionNames
- Other: Semi-structured interviews
Primary outcomes (4)
- measure
- Change in physical activity
- timeFrame
- Through completion of surgery (estimated to be approximately 12-20 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility Criteria Patients: * A physician-confirmed diagnosis of breast cancer (stage I-III) * Female over the age of 18 * Scheduled to receive curative-intent breast surgery and chemotherapy (neoadjuvant or adjuvant) * Able to understand and willing to sign an Institutional Review Board (IRB)-approved informed consent document. Given documented mental and cognitive health declines after both neoadjuvant and adjuvant treatment regimens, the investigators are including both patient populations in this exploratory study. Patients of all baseline anxiety, depression, cognitive function, and physical activity levels are eligible to participate. Eligibility Criteria Stakeholders: * Healthcare personnel with a staked interest in patient care during chemotherapy, including but not limited to surgical oncologists, medical oncologists, physical and occupational therapists, nurses, patient navigators, dietitians, and exercise physiologists * Able to understand and willing to sign an IRB-approved informed consent document
References
Publications (0)
Data not yet available