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

Completed

• Conditions: Breast Cancer; Breast Neoplasms; Cancer, Breast; Cancer of the Breast
• Interventions: Other: Actigraph; Other: Questionnaires; Other: BrainBaseline application; Other: Semi-structured interviews

• Registration Number: NCT06595901
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Primary Completion: 2023-06-23
• Study Completion: 2023-06-23
• Status Verified: 2024-09
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-16
• Last Update Posted: 2024-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in physical activity	Through completion of surgery (estimated to be approximately 12-20 weeks)	Assessed using an Actigraph hip-worn accelerometer
Change in depression and anxiety	Through completion of surgery (estimated to be approximately 12-20 weeks)	Assessed using the PHQ-ADS
Change in cognitive function (self-reported)	Through completion of surgery (estimated to be approximately 12-20 weeks)	Assessed using the FACT-Cog
Change in cognitive function (objective)	Through completion of surgery (estimated to be approximately 12-20 weeks)	Assessed using the BrainBaseline application

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States