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Completed
NCT07819045
Self-Acceptance and Supportive Accountability for Active Living Among Adults Receiving Chemotherapy
Conditions: Metastatic Invasive Breast Cancer, Metastatic Invasive Gynecologic Cancer
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: NA
Enrollment: 42
Sponsor: University of Oklahoma
Location: TSET Health Promotion Research Center, Oklahoma City, Oklahoma 73104 Oklahoma City Oklahoma
Summary
Physical activity can improve health-related quality of life among people receiving cancer treatment. Yet, chemotherapy imposes considerable barriers to maintaining an active lifestyle. Emotion regulation-based approaches based on principles from Self-Determination Theory (SDT) and Acceptance and Commitment Therapy (ACT) may help people engage in physical activity despite treatment-related challenges. We aimed to develop and conduct a proof of concept study among people initiating chemotherapy for breast and gynecologic cancers to develop and assess the feasibility and acceptability of a novel, mobile health physical activity intervention that drew from SDT and ACT principles.
Eligibility Criteria
Inclusion criteria:
* Having ever received a histologically confirmed diagnosis of 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 explicitly approved by the study team)
* Scheduled to receive cytotoxic chemotherapy for a minimum of 4 consecutive weeks but not yet begun or are within 4 weeks of having started their chemotherapy for cancer
* Ability to speak and read English
* Having internet access
* 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
Exclusion criteria:
* Eastern Cooperative Oncology Group test score \> 2
* Having unstable bone metastases
* Untreated brain metastases
* Contraindications to physical activity (e.g., uncontrolled hypertension or cardiac disease)
* Having a body mass index under 18
* Major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or complete the study
* Having arthritic or orthopedic issues that would preclude physical exercise
* Another member of the household is a primary participant or staff member on this trial
* Being a prisoner
* Living in an assisted living facility or nursing home
* Enrolled in hospice
Source: ClinicalTrials.gov (NCT07819045). StuddyBuddy aggregates publicly available trial information.