Promoting Active Living Among People With Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acceptance- and mindfulness-based physical activity promotion.
- Who it may be relevant to
- Registry conditions: Metastatic Invasive Breast Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Testing the Feasibility and Acceptability of a Remotely Delivered Program to Promote Active Living Among People With Metastatic Breast Cancer
Overview
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.
Interventions
- Behavioral Acceptance- and mindfulness-based physical activity promotion
This intervention will be delivered over the course of up to 8-12 weeks. It will include: 1. the provision of a wearable physical activity tracker 2. empirically supported behavior change techniques for promoting physical activity 3. Acceptance and Commitment Therapy-informed didactic content centered on promoting physical activity 4. a social component with game design elements reflecting acceptance and mindfulness practices (i.e., the ability to share responses to "Weekly Challenges" and vie
Primary outcome measures
- Semi-structured Interviews [Time frame: Week 9]
- Perceived ease of use [Time frame: Week 9]
- Perceived Usefulness [Time frame: Week 9]
- Enjoyability - Face Valid Questions [Time frame: Week 9]
- Enjoyability - Interest/Enjoyment Subscale [Time frame: Week 9]
- Feasibility of the Program - Study Retention [Time frame: Week 9]
- Feasibility of the Program - Adherence [Time frame: Week 9]
- Feasibility of Collecting Biological Samples [Time frame: Week 9]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- TSET Health Promotion Research Center — Oklahoma City
Identifiers
NCT: NCT07238023 · 18941P