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Active Not Recruiting
NCT07238023
Promoting Active Living Among People With Advanced Cancer
Conditions: Metastatic Invasive Breast Cancer, Metastatic Invasive Gynecologic Cancer
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: University of Oklahoma
Location: TSET Health Promotion Research Center Oklahoma City Oklahoma
Summary
Individuals with metastatic 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 or gynecologic cancer. A single group, pretest-posttest trial (N=36) will be conducted to inform scalable strategies to promote active living and enhance quality of life among people with advanced cancer.
Eligibility Criteria
Inclusion criteria:
Having ever received a histologically confirmed diagnosis of stage 4 invasive breast or gynecologic carcinoma (eligible cancer types include epithelial ovarian carcinoma, endometrial/uterine carcinoma, and invasive cervical carcinoma; other rare gynecologic malignancies \[e.g., vaginal, vulvar\] may also be included if approved by the study team)
medical clearance from healthcare provider to participate in this study (which encourages unsupervised, low-intensity physical activity such as walking, stretching, and gentle muscle-strengthening exercises)
life expectancy of at least 6 months as per the participant's healthcare provider
Eastern Cooperative Oncology Group performance status of or 0, 1, or 2
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 and/or high risk by the treating healthcare provider
untreated brain metastases
history of dementia or other major neurocognitive disorder
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
Source: ClinicalTrials.gov (NCT07238023). StuddyBuddy aggregates publicly available trial information.