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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-10

Study Completion Date

2023-06-23

Brief Summary

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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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Detailed Description

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Conditions

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Breast Cancer Breast Neoplasms Cancer, Breast Cancer of the Breast

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

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

Actigraph

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

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.

Semi-structured interviews

Intervention Type 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.

Interventions

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Actigraph

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

Intervention Type 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).

Intervention Type 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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No