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

NCT ID: NCT03367923

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-03-25

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Counseling

Intervention Type OTHER

Undergo exercise counseling

Fitbit tracker

Intervention Type OTHER

Wear Fitbit tracker

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Receive phone call

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.

Group Type EXPERIMENTAL

Communication Intervention

Intervention Type OTHER

Receive email/text

Counseling

Intervention Type OTHER

Undergo exercise counseling

Fitbit tracker

Intervention Type OTHER

Wear Fitbit tracker

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Communication Intervention

Receive email/text

Intervention Type OTHER

Counseling

Undergo exercise counseling

Intervention Type OTHER

Fitbit tracker

Wear Fitbit tracker

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Telephone-Based Intervention

Receive phone call

Intervention Type BEHAVIORAL

Other Intervention Names

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Counseling Intervention Device Quality of Life Assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Kidd

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University, School of Medicine

Palo Alto, California, United States

Site Status

Stanford Cancer Center South Bay

San Jose, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2017-02149

Identifier Type: REGISTRY

Identifier Source: secondary_id

GYNEND0002

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-43094

Identifier Type: -

Identifier Source: org_study_id