Health and Recovery Program in Increasing Physical Activity Level in Stage IA-IIIA Endometrial Cancer Survivors
| Status: | Recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | December 1, 2017 |
| End Date: | April 1, 2021 |
| Contact: | Melissa Usoz |
| Email: | musoz@stanford.edu |
| Phone: | 650-723-8843 |
Step Into Wellness: A Program of Health and Recovery for Endometrial Cancer Survivors
This randomized phase II trial studies how well a health and recovery program works in
increasing physical activity level in stage IA-IIIA endometrial cancer survivors. Health and
recovery program which includes exercise counseling, Fitbit tracker, and phone or email/text
communication may increase the level of physical activity in endometrial cancer survivors and
promote and maintain behavior change at a lower cost.
increasing physical activity level in stage IA-IIIA endometrial cancer survivors. Health and
recovery program which includes exercise counseling, Fitbit tracker, and phone or email/text
communication may increase the level of physical activity in endometrial cancer survivors and
promote and maintain behavior change at a lower cost.
PRIMARY OBJECTIVES:I. Determine the increase in activity level per participant where the
baseline average number of steps is recorded during week 0-2 will be compared to average step
count recorded during week 20-28.SECONDARY OBJECTIVES:I. Determining the rate of patients who
have achieved a 50% increase in activity level in each communication group (telephone versus
[vs.] electronic).II. Demonstrate that the rate of patients who have achieved an increased
activity level of 50% as compared to the patient's baseline in the electronic/email group is
not inferior to the rate in the telephone group.III. Evaluate changes in body mass index
(BMI), waist circumference, blood pressure and pulse for the whole group, by communication
group (electronic vs. telephone), and by activity level.IV. Evaluate the changes in quality
of life, as assessed by Functional Assessment of Cancer Therapy-General (FACT-G), during the
course of the study for the whole group, between the two groups (electronic vs. telephone),
and based on activity level.V. Evaluate maintenance of activity level at 9 month (m) (week
32-40) (comparison activity level 9 m vs. 6 m) for the whole group, by group (electronic vs.
telephone), and by activity level.OUTLINE: Patients are randomized to 1 of 2 arms.ARM I:
Participants undergo an exercise counseling session at baseline and wear Fitbit tracker daily
for 9 months. Participants receive a short phone call at 2, 4, 6, and 8 weeks, and at 4 and 5
months to discuss the average number of daily steps over the past 2 weeks and to encourage a
goal of a 10% increase over the next 2-4 week time period.ARM II: Participants undergo an
exercise counseling session at baseline and wear Fitbit tracker daily for 9 months.
Participants receive an electronic communication (email/text) of their choice at 2, 4, 6, and
8 weeks, and at 4 and 5 months stating the average number of daily steps over the past 2
weeks and encouraging a goal of a 10% increase over the next 2-4 week time period.
baseline average number of steps is recorded during week 0-2 will be compared to average step
count recorded during week 20-28.SECONDARY OBJECTIVES:I. Determining the rate of patients who
have achieved a 50% increase in activity level in each communication group (telephone versus
[vs.] electronic).II. Demonstrate that the rate of patients who have achieved an increased
activity level of 50% as compared to the patient's baseline in the electronic/email group is
not inferior to the rate in the telephone group.III. Evaluate changes in body mass index
(BMI), waist circumference, blood pressure and pulse for the whole group, by communication
group (electronic vs. telephone), and by activity level.IV. Evaluate the changes in quality
of life, as assessed by Functional Assessment of Cancer Therapy-General (FACT-G), during the
course of the study for the whole group, between the two groups (electronic vs. telephone),
and based on activity level.V. Evaluate maintenance of activity level at 9 month (m) (week
32-40) (comparison activity level 9 m vs. 6 m) for the whole group, by group (electronic vs.
telephone), and by activity level.OUTLINE: Patients are randomized to 1 of 2 arms.ARM I:
Participants undergo an exercise counseling session at baseline and wear Fitbit tracker daily
for 9 months. Participants receive a short phone call at 2, 4, 6, and 8 weeks, and at 4 and 5
months to discuss the average number of daily steps over the past 2 weeks and to encourage a
goal of a 10% increase over the next 2-4 week time period.ARM II: Participants undergo an
exercise counseling session at baseline and wear Fitbit tracker daily for 9 months.
Participants receive an electronic communication (email/text) of their choice at 2, 4, 6, and
8 weeks, and at 4 and 5 months stating the average number of daily steps over the past 2
weeks and encouraging a goal of a 10% increase over the next 2-4 week time period.
Inclusion Criteria:
- Stage IA-IIIA endometrial cancer patients with pathology reviewed at Stanford
- Patients must have undergone surgery as a part of their treatment for their
endometrial cancer
- At least 3 months post treatment
- BMI > 25
- Life expectancy of at least one year
- Able to perform physical activity of walking
- Possession of a computer and/or smart phone and/or smart tablet
- Must be English or Spanish speaking
Exclusion Criteria:
- Other active cancer
- Receiving chemotherapy or other active treatment
- BMI < 60
- Diagnosis of uterine serous carcinoma or uterine sarcoma
We found this trial at
2
sites
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Palo Alto, California 94304
Principal Investigator: Elizabeth A. Kidd
Phone: 650-723-8843
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