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Health and Recovery Program in Increasing Physical Activity Level in Stage IA-IIIA Endometrial Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03367923
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment Phase
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 Other: Communication Intervention Other: Counseling Other: Fitbit tracker Other: Quality-of-Life Assessment Other: Questionnaire Administration Behavioral: Telephone-Based Intervention Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Step Into Wellness: A Program of Health and Recovery for Endometrial Cancer Survivors
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (exercise counseling, Fitbit, phone call)
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.
Other: Counseling
Undergo exercise counseling
Other Name: Counseling Intervention

Other: Fitbit tracker
Wear Fitbit tracker
Other Name: Device

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Behavioral: Telephone-Based Intervention
Receive phone call

Experimental: Arm II (exercise counseling, Fitbit, email/text)
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.
Other: Communication Intervention
Receive email/text

Other: Counseling
Undergo exercise counseling
Other Name: Counseling Intervention

Other: Fitbit tracker
Wear Fitbit tracker
Other Name: Device

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Increase in activity level measured using Fitbit tracker [ Time Frame: Up to week 20-28 ]
    The increase in activity level will be determined where the baseline average number of steps recorded per patient during week 0 - 2 will be compared to the average step count recorded during week 20 - 28. The baseline measurement will be defined as the average step count reported by the patient during 0-2 weeks. At each subsequent time point the average step count per patient will be the average of the step counts recorded during the 2-4 weeks prior to the follow up visit. The average step count measured at 20-28 weeks will be compared to the baseline in a paired t test. The paired t test will


Secondary Outcome Measures :
  1. Body mass index (BMI) [ Time Frame: Up to 9 months ]
    BMI will be measured using the participant weight in kilograms over height (in meters) squared. Changes in BMI over time will be evaluated in a repeated measures model allowing for within patient correlation. The relationship between average step count and the BMI will be evaluated in a repeated measures model allowing for within patient correlation. Determining if there is a difference between the two groups in the relationship between step count and health measures outcome: BMI will also be evaluated in a repeated measures model allowing for within patient correlation.

  2. Pulse [ Time Frame: Up to 9 months ]
    Pulse will be measured using an automated cuff while the participant is sitting. Changes in pulse over time will be evaluated in a repeated measures model allowing for within patient correlation.

  3. Blood pressure [ Time Frame: Up to 9 months ]
    Blood pressure will be measured using an automated cuff while the participant is sitting. Changes in blood pressure over time will be evaluated in a repeated measures model allowing for within patient correlation.

  4. Quality of life assessment using Functional Assessment of Cancer Therapy-General (FACT-G) [ Time Frame: Up to 9 months ]
    The relationship between average step count and quality of life will be evaluated in a repeated measures model allowing for within patient correlation. Determining if there is a difference between the two groups in the relationship between step count and quality of life will also be evaluated in a repeated measures model allowing for within patient correlation.

  5. Rate of increased activity level measured using Fitbit tracker [ Time Frame: Up to week 20-28 ]
    For each patient, the average step count for the time period week 20 - 28 will be compared to the baseline (week 0-2) average step count. If the increase in step count is 50% or more the patient will have achieved an increased activity level. The proportion of patients who have achieved an increased activity level will be calculated for each arm.

  6. Rate of increased activity level measured using Fitbit tracker [ Time Frame: Up to 9 months ]
    For each patient, the average step count for the time period 6 months (weeks 20-28) will be compared to the baseline average step count. Likewise, for each patient the average step count for the time period 9 months (weeks 32-40) will be compared to the baseline average step count. The proportion of patients who have achieved an increased activity level will be calculated for each arm at each time period 6 months and 9 months.

  7. Waist circumference [ Time Frame: Up to 9 months ]
    Waist circumference will be measured in centimeters at the level of the belly button while participant is standing. Changes in waist circumference over time will be evaluated in a repeated measures model allowing for within patient correlation. The relationship between average step count and the outcomes of: waist circumference will be evaluated in a repeated measures model allowing for within patient correlation. Determining if there is a difference between the two groups in the relationship between step count and health measures outcomes: waist circumference will also be evaluated in a repea



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367923


Contacts
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Contact: Melissa Usoz 650-723-8843 musoz@stanford.edu

Locations
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United States, California
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Melissa Usoz    650-723-8843    musoz@stanford.edu   
Principal Investigator: Elizabeth A. Kidd         
Stanford Cancer Center South Bay Recruiting
San Jose, California, United States, 95124
Contact: Melissa Usoz    650-723-8843    musoz@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Elizabeth Kidd Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT03367923     History of Changes
Other Study ID Numbers: GYNEND0002
NCI-2017-02149 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GYNEND0002 ( Other Identifier: Stanford Cancer Institute Palo Alto )
43094 ( Other Identifier: Stanford IRB )
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female