CancerProject KNOWNNCT05490641
Know and Own Your Movement-related Metrics Via Wearable Devices
A study testing Glucose-based biofeedback and Standard feedback in people with Cancer and Survivorship, run by The University of Texas at Arlington at 1 site in United States.
Trial summary
This study aims to promote daily physical activity in cancer survivors who are at high risk for type 2 diabetes (T2D) by using a personalized biological-based feedback strategy. T2D is one of the most common co-occurring conditions in cancer survivors and can worsen cancer-related health outcomes, especially in those… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Survivorship
- What is being tested?
- Glucose-based biofeedback and Standard feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 10 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be 18 years or older
- have had a diagnosis of cancer
- have completed curative-intended treatment for at least 3 months (except hormone therapy or long-term maintenance chemotherapy)
- be at high-risk for type 2 diabetes based on the American Diabetes Association Type 2 Diabetes Risk Test
- currently insufficiently active
- capable of participating in moderate-vigorous intensity unsupervised exercise
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- have no current diagnosis or history of type 1 or 2 diabetes
- able to speak, read, and write in English
- have a smartphone with daily internet access
Who cannot join
- currently taking oral antidiabetic agents (OADs)
- current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin
- currently pregnant
- on dialysis
- have self-reported health issues that limit physical activity
- work overnight shifts
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- unwilling to use the study devices
- current participation in other exercise or weight loss-related program or intervention
- currently on a low-carb diet
- current use of other implanted medical devices such as pacemakers
- do not have a smartphone that is compatible with the Fitbit and the LibreLink apps
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Arlington
Arlington, Texas, 76010
About this study
Official title: Personalized Feedback of Wearable Biological Sensor Data to Promote Active Living in Cancer Survivors
This study aims to promote daily physical activity in cancer survivors who are at high risk for type 2 diabetes (T2D) by using a personalized biological-based feedback strategy. T2D is one of the most common co-occurring conditions in cancer survivors and can worsen cancer-related health outcomes, especially in those who are insufficiently active. The investigators hypothesize that seeing the immediate impacts of exercise on their biological status will motivate cancer survivors to exercise. The investigators will use real-time data from continuous glucose monitor to demonstrate the acute impact of physical activity and measure daily activity levels using wearable trackers. As wearable sensor technology is constantly advancing, this study is the first step to exploring how researchers can use wearable sensors to help people make a direct connection between their daily behaviors and health outcomes.
Read the detailed description
Physical activity plays an important role in energy balance and obesity, which is an independent risk factor for cancer recurrence and mortality. It has been estimated that cancer survivors who increased their physical activity from pre- to post-diagnosis by any level had a 39% risk reduction in total mortality. This study will use an innovative approach to motivate cancer survivors to adopt and maintain an active lifestyle and will explore a novel mediator (daily glucose pattern) of the association between physical activity and cancer-related biomarkers. Study participants will be randomly assigned into (1) a group that receives personalized biological feedback related to physical activity behaviors; and (2) a control group that receives standard educational material. The feasibility and preliminary efficacy of this wearable sensor-based, biofeedback-enhanced 12-week physical activity intervention will be evaluated. This study will provide data regarding the preliminary efficacy of using biological feedback to increase physical activity and identifying daily glucose patterns that might link to cancer-related biomarkers.
The overall goals for this study are: (1) to test the preliminary effect of a remotely delivered physical activity intervention that incorporates personalized biological-based feedback on daily physical activity levels, and (2) to explore the association between daily glucose patterns and cancer-related insulin pathway and inflammatory biomarkers in cancer survivors who are at high risk for type 2 diabetes.
- Conditions
- Cancer, Survivorship
- Being tested
- Glucose-based biofeedback, Standard feedback
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose-based biofeedbackBehavioural
Participants will wear a Fitbit activity tracker and receive personalized text messages over a 12-week period. During the first 4 weeks of the study period, participants will also wear a continuous glucose monitor to check their glucose levels in real-time and receive text messages based on their activity and glucose data.
Standard feedbackBehavioural
Participants will wear a Fitbit activity tracker and receive non-personalized text messages over a 12-week period.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback Group | Experimental | Not described Receives: Behavioral: Glucose-based biofeedback |
| Standard Care Group | Active comparator | Not described Receives: Behavioral: Standard feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of delivering personalized glucose-based feedback
The intervention will be considered feasible if ≥ 80% of participants in the intervention group are adherent to the self-monitoring protocol and ≥ 80% of participants complete the post-intervention assessment.
Measured: Through study completion, an average of 3 months.
Secondary outcomes (1)
Changes in daily physical activity level
A blinded accelerometry device will be used to measure physical activity before and after the intervention.
Measured: Through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start29 Mar 2023
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Collaborators
- American Institute for Cancer Research
- Responsible party
- Principal investigator, Yue Liao, The University of Texas at Arlington
- Investigators
- Yue Liao, MPH, PhD, Principal investigator, University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490641
- Sponsor's protocol ID
- 2022-0177
- Acronym
- Project KNOWN
- Status last verified
- Feb 2026
- First submitted
- 1 Aug 2022
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liao Y, Schembre SM, Brannon GE, Pan Z, Wang J, Ali S, Beg MS, Basen-Engquist KM. Using wearable biological sensors to provide personalized feedback to motivate behavioral changes: Study protocol for a randomized controlled physical activity intervention in cancer survivors (Project KNOWN). PLoS One. 2022 Sep 13;17(9):e0274492. doi: 10.1371/journal.pone.0274492. eCollection 2022.
PubMed 36099282
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Feedback of Wearable Biological Sensor Data to Promote Active Living in Cancer Survivors
- ClinicalTrials.gov ID
- NCT05490641
- Acronym / sponsor ID
- Project KNOWN / 2022-0177
- Conditions
- Cancer, Survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Collaborators
- American Institute for Cancer Research
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 5 Aug 2022 (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.
This study aims to promote daily physical activity in cancer survivors who are at high risk for type 2 diabetes (T2D) by using a personalized biological-based feedback strategy. T2D is one of the most common co-occurring conditions in cancer survivors and can worsen cancer-related health outcomes, especially in those who are insufficiently active. The investigators hypothesize that seeing the immediate impacts of exercise on their biological status will motivate cancer survivors to exercise. The investigators will use real-time data from continuous glucose monitor to demonstrate the acute impact of physical activity and measure daily activity levels using wearable trackers. As wearable sensor technology is constantly advancing, this study is the first step to exploring how researchers can use wearable sensors to help people make a direct connection between their daily behaviors and health outcomes.
Detailed description
Physical activity plays an important role in energy balance and obesity, which is an independent risk factor for cancer recurrence and mortality. It has been estimated that cancer survivors who increased their physical activity from pre- to post-diagnosis by any level had a 39% risk reduction in total mortality. This study will use an innovative approach to motivate cancer survivors to adopt and maintain an active lifestyle and will explore a novel mediator (daily glucose pattern) of the association between physical activity and cancer-related biomarkers. Study participants will be randomly assigned into (1) a group that receives personalized biological feedback related to physical activity behaviors; and (2) a control group that receives standard educational material. The feasibility and preliminary efficacy of this wearable sensor-based, biofeedback-enhanced 12-week physical activity intervention will be evaluated. This study will provide data regarding the preliminary efficacy of using biological feedback to increase physical activity and identifying daily glucose patterns that might link to cancer-related biomarkers.
The overall goals for this study are: (1) to test the preliminary effect of a remotely delivered physical activity intervention that incorporates personalized biological-based feedback on daily physical activity levels, and (2) to explore the association between daily glucose patterns and cancer-related insulin pathway and inflammatory biomarkers in cancer survivors who are at high risk for type 2 diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Group | Experimental | Behavioral: Glucose-based biofeedback |
| Standard Care Group | Active comparator | Behavioral: Standard feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be 18 years or older
- have had a diagnosis of cancer
- have completed curative-intended treatment for at least 3 months (except hormone therapy or long-term maintenance chemotherapy)
- be at high-risk for type 2 diabetes based on the American Diabetes Association Type 2 Diabetes Risk Test
- currently insufficiently active
Key exclusion criteria (11 listed)
- currently taking oral antidiabetic agents (OADs)
- current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin
- currently pregnant
- on dialysis
- have self-reported health issues that limit physical activity
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 |
|---|---|---|
| Glucose-based biofeedbackParticipants will wear a Fitbit activity tracker and receive personalized text messages over a 12-week period. During the first 4 weeks of the study period, participants will also wear a continuous glucose monitor to check their glucose levels in real-time and receive text messages based on their activity and glucose data. | Behavioural | Biofeedback Group |
| Standard feedbackParticipants will wear a Fitbit activity tracker and receive non-personalized text messages over a 12-week period. | Behavioural | Standard Care Group |
Primary outcome
Feasibility of delivering personalized glucose-based feedback
Time frame: Through study completion, an average of 3 months.
The intervention will be considered feasible if ≥ 80% of participants in the intervention group are adherent to the self-monitoring protocol and ≥ 80% of participants complete the post-intervention assessment.
1 secondary outcome
Changes in daily physical activity level
Time frame: Through study completion, an average of 3 months.
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 13 Feb 2026.
- Derived from this study: PubMed 36099282Liao Y, Schembre SM, Brannon GE, Pan Z, Wang J, Ali S, Beg MS, Basen-Engquist KM. Using wearable biological sensors to provide personalized feedback to motivate behavioral changes: Study protocol for a randomized controlled physical activity intervention in cancer survivors (Project KNOWN). PLoS One. 2022 Sep 13;17(9):e0274492. doi: 10.1371/journal.pone.0274492. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Yue Liao, MPH, PhD principal investigator
University of Texas at Arlington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose-based biofeedback and Standard feedback in people with Cancer and Survivorship, run by The University of Texas at Arlington 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 11 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 13 Feb 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?
Feasibility of delivering personalized glucose-based feedback (time frame: Through study completion, an average of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05490641, which also lists 1 linked publication.
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 13 Feb 2026.