Clinical trial NCT06595901: Mental and Cognitive Health and Physical Activity in the Perioperative Breast Cancer Setting
Official title: Characterizing Mental and Cognitive Health and Physical Activity in the Perioperative Breast Cancer Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast Neoplasms
Cancer, Breast
Cancer of the Breast
Keywords: Breast cancer
Physical activity
Prehabilitation
Cognition
Stakeholder needs
Implementation science
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-09-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stages I-III breast cancer at Siteman Cancer Center (SCC) and stakeholders drawn from the surrounding BJC and Washington University healthcare systems.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in physical activity
timeFrame: Through completion of surgery (estimated to be approximately 12-20 weeks)
measure: Change in depression and anxiety
timeFrame: Through completion of surgery (estimated to be approximately 12-20 weeks)
measure: Change in cognitive function (self-reported)
timeFrame: Through completion of surgery (estimated to be approximately 12-20 weeks)
measure: Change in cognitive function (objective)
timeFrame: Through completion of surgery (estimated to be approximately 12-20 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Elizabeth A Salerno, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: