Invasive Breast CarcinomaNCT07819045
Self-Acceptance and Supportive Accountability for Active Living Among Adults Receiving Chemotherapy
A study testing Acceptance- and Mindfulness-Based Intervention in people with Invasive Breast Carcinoma and Gynecologic Malignancies, run by University of Oklahoma at 1 site in United States.
Trial summary
Physical activity can improve health-related quality of life among people receiving cancer treatment. Yet, chemotherapy imposes considerable barriers to maintaining an active lifestyle. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Invasive Breast Carcinoma, Gynecologic Malignancies
- What is being tested?
- Acceptance- and Mindfulness-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to 15 Jun 2026
- Phase
- Interventional
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 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 explicitly approved by the study team)
- Scheduled to receive cytotoxic chemotherapy for a minimum of 4 consecutive weeks but not yet begun or are within 4 weeks of having started their chemotherapy for cancer
- Ability to speak and read English
- Having internet access
- 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
Who cannot join
- Eastern Cooperative Oncology Group test score > 2
- Having unstable bone metastases
- Untreated brain metastases
- Contraindications to physical activity (e.g., uncontrolled hypertension or cardiac disease)
- Having a body mass index under 18
- Major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or complete the study
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- Having arthritic or orthopedic issues that would preclude physical exercise
- Another member of the household is a primary participant or staff member on this trial
- Being a prisoner
- Living in an assisted living facility or nursing home
- Enrolled in hospice
Trial locations and contacts
1 site in 1 country.
United States1 site
TSET Health Promotion Research Center, Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma, 73104
About this study
Physical activity can improve health-related quality of life among people receiving cancer treatment. Yet, chemotherapy imposes considerable barriers to maintaining an active lifestyle. Emotion regulation-based approaches based on principles from Self-Determination Theory (SDT) and Acceptance and Commitment Therapy (ACT) may help people engage in physical activity despite treatment-related challenges. We aimed to develop and conduct a proof of concept study among people initiating chemotherapy for breast and gynecologic cancers to develop and assess the feasibility and acceptability of a novel, mobile health physical activity intervention that drew from SDT and ACT principles.
- Being tested
- Acceptance- and Mindfulness-Based Intervention
- 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 InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Acceptance- and Mindfulness-Based Digital Intervention | Experimental | Provision of acceptance and mindfulness-based physical activity promotion Receives: Behavioral: Acceptance- and Mindfulness-Based Intervention |
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: 9 weeks
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 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 posted14 Sep 2026
- Study start10 Sep 2025
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast CarcinomaStudies of the same condition, open and under way.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- TSET Health Promotion Research Center, Presbyterian Health Foundation
- Responsible party
- Sponsor
- Investigators
- Michael C. Robertson, PhD, MPH, Principal investigator, University of Oklahoma Health Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819045
- Sponsor's protocol ID
- 18010P
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made publicly available due to the small sample size and the potential risk of participant re-identification. Data sharing restrictions are intended to protect participant privacy and confidentiality.