Promoting Active Living Among People With Metastatic Breast Cancer

NCT07238023 | Recruiting

• 1 other identifier: 18941P
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Semi-structured Interviews

  Semi-structured interviews will be used to assess participants' overall experience and their perceptions of the usability, usefulness, and enjoyability of the intervention.

  Week 9

• Perceived ease of use

  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.

  Week 9

• Perceived Usefulness

  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.

  Week 9

• Enjoyability - Face Valid Questions

  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.

  Week 9

• Enjoyability - Interest/Enjoyment Subscale

  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.

  Week 9

• Feasibility of the Program - Study Retention

  We will assess program feasibility via measurements of study retention. We will compute what percentage of enrolled participant complete post-intervention data collection procedures.

  Week 9

• Feasibility of the Program - Adherence

  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.

  Week 9

• Feasibility of Collecting Biological Samples

  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.

  Week 9

Other Outcomes (15)

• Physical Activity

  Baseline; Week 9

• Feelings of Vitality

  Baseline; Week 9

• Meaning Salience

  Baseline; Week 9

Study Arms (1)

Acceptance- and Mindfulness-Based Intervention

EXPERIMENTAL

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

Behavioral: Acceptance- and mindfulness-based physical activity promotion

Interventions

Acceptance- and mindfulness-based physical activity promotion BEHAVIORAL

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).

Acceptance- and Mindfulness-Based Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• TSET Health Promotion Research Center: collaborator

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Study Officials

• Michael C Robertson, MPH, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael C Robertson, PhD, MPH

CONTACT

14052718001; Michael-Robertson@ou.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 20, 2025
• Study Start: February 27, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

US (1)