Metastatic Invasive Breast CancerNCT07238023
Promoting Active Living Among People With Advanced Cancer
A study testing Acceptance- and mindfulness-based physical activity promotion in people with Metastatic Invasive Breast Cancer and Metastatic Invasive Gynecologic Cancer, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metastatic Invasive Breast Cancer, Metastatic Invasive Gynecologic Cancer
- What is being tested?
- Acceptance- and mindfulness-based physical activity promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2026to 2 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having ever received a histologically confirmed diagnosis of stage 4 invasive breast or gynecologic carcinoma (eligible cancer types include epithelial ovarian carcinoma, endometrial/uterine carcinoma, and invasive cervical carcinoma; other rare gynecologic malignancies [e.g., vaginal, vulvar] may also be included if approved by the study team)
- medical clearance from healthcare provider to participate in this study (which encourages unsupervised, low-intensity physical activity such as walking, stretching, and gentle muscle-strengthening exercises)
- life expectancy of at least 6 months as per the participant's healthcare provider
- Eastern Cooperative Oncology Group performance status of or 0, 1, or 2
- 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
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- 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
Who cannot join
- 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 and/or high risk by the treating healthcare provider
- untreated brain metastases
- history of dementia or other major neurocognitive disorder
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
TSET Health Promotion Research Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Testing the Feasibility and Acceptability of a Remotely Delivered Program to Promote Active Living Among People With Advanced Cancer
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.
- Being tested
- Acceptance- and mindfulness-based physical activity promotion
- Keywords
- aerobic physical activity, muscle strengthening physical activity, mindfulness, acceptance, telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance- and mindfulness-based physical activity promotionBehavioural
This intervention will be delivered over the course of up to 8-12 weeks.
It will include:
- the provision of a wearable physical activity tracker
- empirically supported behavior change techniques for promoting physical activity
- Acceptance and Commitment Therapy-informed didactic content centered on promoting physical activity
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Acceptance- and Mindfulness-Based Intervention | Experimental | Provision of standard self-regulatory behavior change techniques, plus acceptance and mindfulness-based physical activity promotion Receives: Behavioral: Acceptance- and mindfulness-based physical activity promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start27 Feb 2026
- Primary completion2 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Invasive Breast CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- TSET Health Promotion Research Center
- Responsible party
- Sponsor
- Investigators
- Michael C Robertson, MPH, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238023
- Sponsor's protocol ID
- 18941P
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are undecided about sharing individual participant data at this time. This study involves a sensitive population and may result in a relatively small sample size, which increases the risk of participant re-identification even after de-identification procedures. We will evaluate data sharing feasibility after study completion, taking into account participant privacy protections, ethical considerations, and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility and Acceptability of a Remotely Delivered Program to Promote Active Living Among People With Advanced Cancer
- ClinicalTrials.gov ID
- NCT07238023
- Acronym / sponsor ID
- 18941P
- Keywords
- aerobic physical activity, muscle strengthening physical activity, mindfulness, acceptance, telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- TSET Health Promotion Research Center
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acceptance- and Mindfulness-Based Intervention | Experimental | Behavioral: Acceptance- and mindfulness-based physical activity promotionProvision of standard self-regulatory behavior change techniques, plus acceptance and mindfulness-based physical activity promotion |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Having ever received a histologically confirmed diagnosis of stage 4 invasive breast or gynecologic carcinoma (eligible cancer types include epithelial ovarian carcinoma, endometrial/uterine carcinoma, and invasive cervical carcinoma; other rare gynecologic malignancies [e.g., vaginal, vulvar] may also be included if approved by the study team)
- medical clearance from healthcare provider to participate in this study (which encourages unsupervised, low-intensity physical activity such as walking, stretching, and gentle muscle-strengthening exercises)
- life expectancy of at least 6 months as per the participant's healthcare provider
- Eastern Cooperative Oncology Group performance status of or 0, 1, or 2
- being willing and able to use a smartphone and web interface with or without assistance; if assistance is needed, it must be readily available
Key exclusion criteria (8 listed)
- 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 and/or high risk by the treating healthcare provider
- untreated brain metastases
- history of dementia or other major neurocognitive disorder
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance- and mindfulness-based physical activity promotionThis 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). | Behavioural | Acceptance- and Mindfulness-Based Intervention |
Primary outcome
Semi-structured Interviews
Time frame: Week 9
Semi-structured interviews will be used to assess participants' overall experience and their perceptions of the usability, usefulness, and enjoyability of the intervention.
Perceived ease of use
Time frame: Week 9
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.
Perceived Usefulness
Time frame: Week 9
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.
Enjoyability - Face Valid Questions
Time frame: Week 9
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.
Enjoyability - Interest/Enjoyment Subscale
Time frame: Week 9
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.
Feasibility of the Program - Study Retention
Time frame: Week 9
We will assess program feasibility via measurements of study retention. We will compute what percentage of enrolled participant complete post-intervention data collection procedures.
Feasibility of the Program - Adherence
Time frame: Week 9
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.
Feasibility of Collecting Biological Samples
Time frame: Week 9
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided. We are undecided about sharing individual participant data at this time. This study involves a sensitive population and may result in a relatively small sample size, which increases the risk of participant re-identification even after de-identification procedures. We will evaluate data sharing feasibility after study completion, taking into account participant privacy protections, ethical considerations, and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Robertson, MPH, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance- and mindfulness-based physical activity promotion in people with Metastatic Invasive Breast Cancer and Metastatic Invasive Gynecologic Cancer, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-structured Interviews (time frame: Week 9). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.