Clinical trial NCT03367923: Health and Recovery Program in Increasing Physical Activity Level in Stage IA-IIIA Endometrial Cancer Survivors
Official title: Step Into Wellness: A Program of Health and Recovery for Endometrial Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer Survivor
Endometrial Carcinoma
Stage I Uterine Corpus Cancer AJCC v7
Stage IA Uterine Corpus Cancer AJCC v7
Stage IB Uterine Corpus Cancer AJCC v7
Stage II Uterine Corpus Cancer AJCC v7
Stage IIIA Uterine Corpus Cancer AJCC v7
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase in activity level measured using Fitbit tracker
timeFrame: Up to week 20-28
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: Up to 9 months
measure: Pulse
timeFrame: Up to 9 months
measure: Blood pressure
timeFrame: Up to 9 months
measure: Quality of life assessment using Functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: Up to 9 months
measure: Rate of increased activity level measured using Fitbit tracker
timeFrame: Up to week 20-28
measure: Rate of increased activity level measured using Fitbit tracker
timeFrame: Up to 9 months
measure: Waist circumference
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
city: San Jose
country: United States
facility: Stanford Cancer Center South Bay
state: California
Study officials:
affiliation: Stanford University
name: Elizabeth Kidd
role: PRINCIPAL_INVESTIGATOR
References: