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Mental and Cognitive Health and Physical Activity in the Perioperative Breast Cancer Setting

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The Washington University

Status

Completed

Conditions

Breast Cancer
Cancer of the Breast
Cancer, Breast
Breast Neoplasms

Treatments

Other: Semi-structured interviews
Other: BrainBaseline application
Other: Actigraph
Other: Questionnaires

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT06595901
202201163
P50MH122351 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

42 participants in 2 patient groups

Patients
Description:
Participants wear ActiGraphs, complete questionnaires via phone call/text message, and participate in interviews remotely on study.
Treatment:
Other: Questionnaires
Other: Actigraph
Other: BrainBaseline application
Other: Semi-structured interviews
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.
Treatment:
Other: Semi-structured interviews

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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