Promoting Active Living Among People With Metastatic Breast Cancer

NCT ID: NCT07238023

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Acceptance- and Mindfulness-Based Intervention

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

Group Type: EXPERIMENTAL

Acceptance- and mindfulness-based physical activity promotion

Intervention Type: 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).

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TSET Health Promotion Research Center

UNKNOWN

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Michael C Robertson, PhD, MPH

Role: CONTACT

Phone: 14052718001

Email: Michael-Robertson@ou.edu

Other Identifiers

18941

Identifier Type: -

Identifier Source: org_study_id