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| Name | Class |
|---|---|
| American Institute for Cancer Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback Group | Experimental |
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| Standard Care Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose-based biofeedback | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in daily physical activity level | A blinded accelerometry device will be used to measure physical activity before and after the intervention. | Through study completion, an average of 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yue Liao, MPH, PhD | University of Texas at Arlington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas at Arlington | Arlington | Texas | 76010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36099282 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 26, 2024 | Feb 10, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Standard feedback | Behavioral | Participants will wear a Fitbit activity tracker and receive non-personalized text messages over a 12-week period. |
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