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Overweight and obese endometrial cancer (EC) survivors at the University of North Carolina (UNC) at Chapel Hill will be approached for tailored feedback fitness intervention. The investigators plan to enroll 36 women (18 in each arm) to evaluate if receipt of weekly tailored feedback messages can improve physical activity in EC survivors. It is hypothesized that women receiving the feedback message intervention will increase step counts from baseline more than 2,000 steps compared to women in the non-intervention arm.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Feedback Messages | Experimental | Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly based on the CHART algorithm (Appendix 1). Participants on the feedback arm will receive 1 message per week during the 3-month study period. |
|
| No Messages | No Intervention | No feedback messages |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Feedback Messages | Behavioral | Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly. Participants on the feedback arm will receive 1 message per week during the 3-month study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention | Steps recorded on a fitness tracker at week 1 and week 13 | 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Clark, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina Cancer Hospital | Chapel Hill | North Carolina | 27599 | United States |
Thirty-nine participants were consented
Participants were recruited from 9/28/2018 to 12/23/2019
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored Feedback Messages | Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly based on the CHART algorithm (Appendix 1). Participants on the feedback arm will receive 1 message per week during the 3-month study period. Tailored Feedback Messages: Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly. Participants on the feedback arm will receive 1 message per week during the 3-month study period. |
| FG001 | No Messages | No feedback messages |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored Feedback Messages | Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly based on the CHART algorithm (Appendix 1). Participants on the feedback arm will receive 1 message per week during the 3-month study period. Tailored Feedback Messages: Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly. Participants on the feedback arm will receive 1 message per week during the 3-month study period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention | Steps recorded on a fitness tracker at week 1 and week 13 | Posted | Mean | Standard Error | Change in steps | 13 weeks |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tailored Feedback Messages | Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly based on the CHART algorithm (Appendix 1). Participants on the feedback arm will receive 1 message per week during the 3-month study period. Tailored Feedback Messages: Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly. Participants on the feedback arm will receive 1 message per week during the 3-month study period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Clark | UNC Lineberger | 919-966-5996 | leslie_Clark@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2019 | Jun 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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|
| BG001 | No Messages | No feedback messages |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| No Messages |
No feedback messages |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | No Messages | No feedback messages | 0 | 18 | 0 | 18 | 0 | 18 |
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |