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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07238023). StuddyBuddy aggregates publicly available trial information.