Recruiting

Mindfulness-Based PA

Sponsor:

University of Oklahoma

Code:

NCT07238023

Conditions

Metastatic Invasive Breast Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Acceptance- and mindfulness-based physical activity promotion

Study Details

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 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.

Conditions

Metastatic Invasive Breast Cancer

Study ID

NCT07238023

Start date

Feb 27, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Acceptance- and Mindfulness-Based Intervention

Provision of standard self-regulatory behavior change techniques, plus acceptance and mindfulness-based physical activity promotion

Interventions

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 view and comment on others' entries).

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Michael C Robertson, PhD, MPH

14052718001Michael-Robertson@ou.edu

Locations

TSET Health Promotion Research Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Michael C Robertson, MPH, PhD

405-998-1451alvy-lab@ou.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • aerobic physical activity
  • muscle strengthening physical activity
  • mindfulness
  • acceptance
  • telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-07-30.