Metastatic Invasive Breast Cancer / Acceptance- and mindfulness-based physical activity promotion / Metastatic Invasive Gynecologic Cancer · Interventional Study

Promoting Active Living Among People With Advanced Cancer

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record documenting a planned single-arm feasibility trial of an acceptance- and mindfulness-based physical activity intervention for people with metastatic breast or gynecologic cancer. The study aims to evaluate acceptability, feasibility, and program characteristics at week 9, but no results are posted in this registry record. This is preliminary work intended to inform design of future larger trials.

What was studied

Interventional, Single Group, Open label, Supportive Care purpose. Metastatic Invasive Breast Cancer, Metastatic Invasive Gynecologic Cancer; age from 18 Years; to 99 Years. Intervention: Acceptance- and Mindfulness-Based Intervention. n = 36. 1 site: United States.

Key findings

Safety

Registry record contains no results or outcome data; efficacy and safety cannot be evaluated.

Who this may help

This feasibility trial is not yet ready to inform clinical practice. Results on acceptability and adherence, when reported, may support progression to a larger randomized trial but will not establish clinical benefit.

Plain-language summary

This is a feasibility and acceptability study with a single-arm design and surrogate endpoints (perceived ease of use, retention, adherence) in a small sample, designed to inform future intervention development rather than establish efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Semi-structured Interviews (assessed at Week 9); Perceived ease of use (assessed at Week 9); Perceived Usefulness (assessed at Week 9); Enjoyability - Face Valid Questions (assessed at Week 9); Enjoyability - Interest/Enjoyment Subscale (assessed at Week 9); Feasibility of the Program - Study Retention (assessed at Week 9); Feasibility of the Program - Adherence (assessed at Week 9); Feasibility of Collecting Biological Samples (assessed at Week 9)

DesignInterventional, Single Group, Open label, Supportive Care purpose

PopulationMetastatic Invasive Breast Cancer, Metastatic Invasive Gynecologic Cancer; age from 18 Years; to 99 Years

Sample size36

InterventionAcceptance- and Mindfulness-Based Intervention

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Sample size36

PhaseNot applicable (feasibility trial)

Primary outcome measure collection timepointWeek 9

Clinical bottom line

Caveats

Registry record contains no results or outcome data; efficacy and safety cannot be evaluated.
Single-arm design without control group prevents causal inference.
Primary outcomes are acceptability and feasibility measures, not clinical or symptom endpoints.
Study recruitment is active-not-recruiting, suggesting data collection may be ongoing or complete, but results are not yet posted.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-group pretest-posttest design without comparator or randomization.

Directness

moderate

Examines acceptability and feasibility outcomes; no clinical or symptom endpoints reported.

Consistency

insufficient

Registry record contains no results; consistency cannot be assessed.

Risk of bias

limited

Single-arm design without blinding or control arm introduces selection and performance bias.

Sample adequacy

limited

N=36 is small and appropriate for feasibility but underpowered for clinical conclusions.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07238023). This is a study registration, not published results. Lead sponsor: University of Oklahoma. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 36 participants (ACTUAL). Conditions: Metastatic Invasive Breast Cancer, Metastatic Invasive Gynecologic Cancer. Interventions: BEHAVIORAL: Acceptance- and mindfulness-based physical activity promotion. Primary outcome measures: Semi-structured Interviews , Week 9; Perceived ease of use , Week 9; Perceived Usefulness , Week 9; Enjoyability - Face Valid Questions , Week 9; Enjoyability - Interest/Enjoyment Subscale , Week 9; Feasibility of the Program - Study Retention , Week 9; Feasibility of the Program - Adherence , Week 9; Feasibility of Collecting Biological Samples , Week 9. Brief summary: Individuals with metastatic 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 or gynecologic cancer. A single group, pretest-posttest trial (N=36) will be conducted to inform scalable strategies to promote active living and enhance quality of life among people with advanced cancer.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Metastatic Invasive Breast CancerNCT07238023Acceptance- and mindfulness-based physical activity promotionMetastatic Invasive Gynecologic CancerUniversity of Oklahoma