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

NCT06595901 | Completed

• 2 other identifiers: 202201163P50MH122351
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms; Cancer, Breast; Cancer of the Breast

Keywords

Breast cancer; Physical activity; Prehabilitation; Cognition; Stakeholder needs; Implementation science

Outcome Measures

Primary Outcomes (4)

• Change in physical activity

  Assessed using an Actigraph hip-worn accelerometer

  Through completion of surgery (estimated to be approximately 12-20 weeks)

• Change in depression and anxiety

  Assessed using the PHQ-ADS

  Through completion of surgery (estimated to be approximately 12-20 weeks)

• Change in cognitive function (self-reported)

  Assessed using the FACT-Cog

  Through completion of surgery (estimated to be approximately 12-20 weeks)

• Change in cognitive function (objective)

  Assessed using the BrainBaseline application

  Through completion of surgery (estimated to be approximately 12-20 weeks)

Study Arms (2)

Patients

Participants wear ActiGraphs, complete questionnaires via phone call/text message, and participate in interviews remotely on study.

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

Stakeholders

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.

Other: Semi-structured interviews

Interventions

Actigraph OTHER

Participants will wear an Actigraph hip-worn accelerometer on their non-dominant hip during all waking hours, and on the wrist while sleeping

Patients

Questionnaires OTHER

* 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).

Patients

BrainBaseline application OTHER

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

Patients

Semi-structured interviews OTHER

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.

Patients; Stakeholders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Elizabeth A Salerno, Ph.D., MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: March 10, 2022
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following publication.
• Access Criteria: Proposals should be directed to e.salerno@wustl.edu.

Locations

US (1)