NCT06595901

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Breast Neoplasms
• Cancer, Breast
• Cancer of the Breast

Interventions

Type	Name	Description
OTHER	Actigraph	Participants will wear an Actigraph hip-worn accelerometer on their non-dominant hip during all waking hours, and on the wrist while sleeping
OTHER	Questionnaires	* Patient Health Questionnaire Anxiety and Depression Scale30 (PHQ-ADS), a validated composite of anxiety and depressive symptoms. * Self-reported cognition will be assessed by the Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog).
OTHER	BrainBaseline application	Objective measures of cognitive function will include those from the BrainBaseline application, a validated research tool developed by Digital Artefacts to remotely measure domains of cognition
OTHER	Semi-structured interviews	Semi-structured individual interviews will be conducted with up to 15 healthcare stakeholders and 15-30 patients with breast cancer at any time during the study period, as determined by participant preference.

Timeline

• Start date: 2022-03-10
• Primary completion: 2023-06-23
• Completion: 2023-06-23
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States