Promoting Active Living Among People With Metastatic Breast Cancer
- Conditions
- Metastatic Invasive Breast Cancer
- Registration Number
- NCT07238023
- Lead Sponsor
- University of Oklahoma
- Brief Summary
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 pilot randomized controlled trial (N=57) will be conducted using a 2:1 allocation favoring the intervention group. Findings will inform scalable strategies to promote active living and enhance quality of life among people with advanced cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 57
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Semi-structured Interviews Week 9 Semi-structured interviews will be used to assess participants' overall experience and their perceptions of the usability, usefulness, and enjoyability of the intervention.
Perceived ease of use Week 9 Face valid questions will be used to determine whether participants found the interventions easy to use. The face valid questions consists of five 7-point Likert-type items. Responses range from "Not At All Easy" (scored as 1) to "Very Easy" (scored as 7). Higher scores reflect greater ease of use.
Perceived Usefulness Week 9 Face valid questions will be used to determine whether participants found the interventions useful. The face valid questions consists of five 7-point Likert-type items. Responses range from "Not At All Useful" (scored as 1) to "Very Useful" (scored as 7). Higher scores reflect greater perceived usefulness.
Enjoyability - Face Valid Questions Week 9 Face valid questions will be used to assess the enjoyability of the interventions in this study. The face valid questions consists of five 7-point Likert-type items. Responses range from "Not At All Enjoyable" (scored as 1) to "Very Enjoyable" (scored as 7). Higher scores reflect greater enjoyability.
Enjoyability - Interest/Enjoyment Subscale Week 9 The interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMIe) will be used to assess the enjoyability of the interventions in this study. The IMIe sub-scale consists of seven 7-point Likert-type items. Responses range from "Not At All True" (scored as 1) to "Very True" (scored as 7). Higher scores reflect greater enjoyability.
Feasibility of the Program - Study Retention Week 9 We will assess program feasibility via measurements of study retention. We will compute what percentage of enrolled participant complete post-intervention data collection procedures.
Feasibility of the Program - Adherence Week 9 We will assess program feasibility via measurements of intervention adherence. We will compute what percentage of participants engage with at least 75% of the intervention modules.
Feasibility of Collecting Biological Samples Week 9 We will assess the feasibility of assessing gene expression in the present context by assessing what percentage of enrolled participants provide analyzable data in optional post-intervention blood draws.
- Secondary Outcome Measures
Name Time Method