Breast Cancer, Breast Neoplasms, Cancer, Breast, Cancer of the Breast
Conditions
Keywords
Breast cancer, Physical activity, Prehabilitation, Cognition, Stakeholder needs, Implementation science
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.
Interventions
OTHERActigraph
Participants will wear an Actigraph hip-worn accelerometer on their non-dominant hip during all waking hours, and on the wrist while sleeping
OTHERQuestionnaires
* 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).
OTHERBrainBaseline 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
OTHERSemi-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.
Sponsors
National Institute of Mental Health (NIMH)
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed