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Completed

NCT Number: NCT06595901

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

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Cancer of the Breast Cancer, Breast Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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).

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

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.

Primary outcomes

  1. Change in physical activity

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

    Assessed using an Actigraph hip-worn accelerometer

  2. Change in depression and anxiety

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

    Assessed using the PHQ-ADS

  3. Change in cognitive function (self-reported)

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

    Assessed using the FACT-Cog

  4. Change in cognitive function (objective)

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

    Assessed using the BrainBaseline application

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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