Endometrial Cancer
Conditions
Brief summary
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.
Detailed description
Objectives: * To assess if a tailored feedback fitness intervention can increase physical activity in EC survivors from baseline to 12 weeks post-baseline * To determine the acceptability of the fitness intervention in EC survivors through a completion survey. * To assess if a tailored feedback message fitness intervention can (1) decrease BMI, (2) reduce waitst to hip (W.H) ratios, (3) improve quality of life (QOL) and (4) improve serum metabolic markers (insulin, glucose and low density lipoprotein (LDL) in EC survivors.
Interventions
BEHAVIORALTailored 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.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be over the age of 18 years * Have a confirmed diagnosis of endometrial cancer and have completed therapy (surgery, chemotherapy or radiation) within the past 6 months * Have no current evidence of endometrial cancer * Have a BMI 25 kg/m2 or greater * Have approval from their treating physician to engage in moderate-intensity physical activity. * Have a smart phone with Bluetooth capabilities turned on * Have access to email
Exclusion criteria
* Are currently undergoing treatment for their cancer * Are unable to read a sample message aloud * Do not have a computer or smart phone with Bluetooth capabilities * Are pregnant * Have a history of angina or palpitations with exertion * Have a history of uncontrolled pulmonary disease (COPD or asthma) * Have one or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention | 13 weeks | Steps recorded on a fitness tracker at week 1 and week 13 |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 9/28/2018 to 12/23/2019
Pre-assignment details
Thirty-nine participants were consented
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| No Messages No feedback messages | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Tailored Feedback Messages | No Messages |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 16 Participants | 16 Participants |
| Age, Continuous | 55.7 years | 55.3 years | 56.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 16 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 25 Participants | 12 Participants | 13 Participants |
| Region of Enrollment United States | 36 participants | 18 participants | 18 participants |
| Sex: Female, Male Female | 36 Participants | 18 Participants | 18 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention
Steps recorded on a fitness tracker at week 1 and week 13
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Feedback Messages | Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention | 1037 Change in steps | Standard Error 0.02 |
| No Messages | Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention | 309 Change in steps | Standard Error 0.4 |