Promoting Active Living Among People With Metastatic Breast Cancer

University of Oklahoma (OU)

Status: Not yet enrolling

Conditions: Metastatic Invasive Breast Cancer

Treatments: Behavioral: Acceptance- and mindfulness-based physical activity promotion

Study type: Interventional

Funder types: Other

Identifiers

NCT07238023

18941

Details and patient eligibility

About

Individuals with metastatic breast cancer are living longer but often face persistent fatigue, functional decline, and psychological distress. Physical activity is generally safe for this population and may alleviate symptom burden. Yet, limited interventions are tailored to the unique and needs and preferences of this population. This study aims to evaluate the acceptability and feasibility of a mindfulness- and acceptance-based physical activity program designed to support mental, social, and spiritual well-being among people with metastatic breast cancer. A single group, pretest-posttest trial (N=38) will be conducted to inform scalable strategies to promote active living and enhance quality of life among people with advanced cancer.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• having been diagnosed with metastatic breast cancer
• medical clearance from healthcare provider to participate in this study
• life expectancy of at least 6 months as per the participant's healthcare provider
• Eastern Cooperative Oncology Group performance status of or 0 or 1
• being willing and able to use a smartphone and web interface with or without assistance; if assistance is needed, it must be readily available
• adequate visual and hearing acuity to use a smartphone and web interface as indicated by self-report
• adequate motor capacity to use a smartphone and web interface as indicated by self-report
• willingness to download and use study-specific app(s), the Fitbit mobile application (this requires use of a Google Gmail account), and other mobile applications for study purposes as needed
• completed baseline survey

Exclusion criteria

• contraindications to physical activity (e.g., uncontrolled hypertension or cardiac disease noted by the patient's treating healthcare provider)
• presence of bone metastases deemed unstable by the treating healthcare provider.
• untreated brain metastases
• history of dementia or other major neurocognitive disorder
• received a diagnosed of Major Depressive Disorder within the previous 6 months
• received a diagnosis of a major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or complete the study
• currently hospitalized
• enrolled in hospice
• inability to speak, read, and write in English at the 7th grade level

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Acceptance- and Mindfulness-Based Intervention

Experimental group

Description:

Provision of standard self-regulatory behavior change techniques, plus acceptance and mindfulness-based physical activity promotion

Treatment:

Behavioral: Acceptance- and mindfulness-based physical activity promotion