Scale Down for Endometrial Cancer

February 27, 2019 updated by: Washington University School of Medicine

Scale Down: A Randomized, Controlled Weight Management Intervention for Women With Endometrial Cancer

This proposal will pilot a weight management program for patients with endometrial cancer, the cancer most associated with obesity. If successful, this pilot could be expanded to include obese women with other gynecologic cancers (ovarian and cervical) and could be expanded and adapted for use not only upon completion of treatment, but during chemotherapy or radiation. Furthermore, other obstetricians and gynecologists could use this strategy for obese women as a practical cancer prevention strategy for obesity-associated cancers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female women 18 years of age or older and with biopsy-proven endometrial cancer.
  • BMI greater than or equal to 30 kg/m^2.
  • Must be able to read and speak English.
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent for Aim 1 study activities in accordance with institutional and federal guidelines.
  • Has completed prior surgical management and adjuvant endometrial cancer treatment, if adjuvant treatment is indicated, prior to starting Aim 1.
  • Is not receiving concurrent cytotoxic chemotherapy and/or radiation therapy at time of enrollment AND, if randomized, is not anticipated that the participant will need to receive concurrent cytotoxic chemotherapy and/or radiation therapy at any time during the Aim 1 intervention
  • Patients with BMI greater than or equal to 30 kg/m^2 who are undergoing hormonal treatment of endometrial cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy of at least one year
  • Must have a phone capable of receiving text messages.

Exclusion Criteria:

  • Females under the age of 18 years
  • BMI less than 30 kg/m^2
  • Must not be participating in another formal weight loss program.
  • Must not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a participant's ability to give informed consent.

  • For participants who are randomized in Aim 1:

    • No uncontrolled serious medical or psychiatric condition(s) that would affect the patient's ability to participate in the interventional study, e.g., uncontrolled hypertension, symptomatic cardiac disease, or severe/uncontrolled depression as indicated by a previously completed Patient Health Questionnaire (PHQ-9) score >9 (Kroenke)
    • No diagnoses of any other invasive malignancy other than endometrial cancer or non-melanoma skin cancer which required active treatment currently or within the last 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: ScaleDown (only first 16 patients)
  • Baseline quality of life and image surveys
  • Weigh themselves every day on the provided Wi-Fi Scale
  • Personalized feedback with text message comes as soon as participants step on the scale
  • At the 6 month time period, quality of life and body image surveys will be completed and in-office anthropometric assessments will be completed
  • At the end of 6 months, the participants will also receive the "Enhanced Usual Care Packet" which provides printed material from the American Cancer Society Website
  • Only 16 participants were in this arm because ScaleDown went out of business
  • At 12 month follow-up weight will be abstracted from medical record
Behavioral: ScaleDown
-Participants receives behavioral prompts and daily feedback by text messaging with motivational instructions for specific dietary and behavior modifications
Behavioral: Enhanced Usual Care Packets
-From the American Cancer Society Website
Other: 12-Item Short Form Health Survey
-Measures functional health and well-being from the patient's perspective
Other: International Physical Activity Questionnaire short form
-7 item scale that measures a range of physical activity from vigorous to sedentary over the last 7 days
Other: Multidimensional Body Self Relations Questionnaire - Appearance Subscales
-Gold-standard for the assessment of body image attitudes and contains 34 items
Other: Cancer-Related Body Image Scale
-13 item scale adapted from The Breast - impact of Treatment Scale, which assesses survivors' intrusive thoughts and avoidant behaviors with respect to their bodies since cancer treatment
Other: Patient Health Questionnaire 9-Item Version
-Widely used measure that assesses mood, including an item that screens for suicidality
Active Comparator: Arm 2: Enhanced Usual Care
  • Baseline quality of life and image surveys
  • Brief in-person counseling session by a research assistant using the Enhanced Usual Care Handouts from the American Cancer Society website which provides guidelines on healthy eating and exercise
  • At the 6 month time period quality of life and body image surveys will be completed and in-office anthropometric assessments will be completed
  • At 12 month follow-up weight will be abstracted from medical record
Behavioral: Enhanced Usual Care Packets
-From the American Cancer Society Website
Other: 12-Item Short Form Health Survey
-Measures functional health and well-being from the patient's perspective
Other: International Physical Activity Questionnaire short form
-7 item scale that measures a range of physical activity from vigorous to sedentary over the last 7 days
Other: Multidimensional Body Self Relations Questionnaire - Appearance Subscales
-Gold-standard for the assessment of body image attitudes and contains 34 items
Other: Cancer-Related Body Image Scale
-13 item scale adapted from The Breast - impact of Treatment Scale, which assesses survivors' intrusive thoughts and avoidant behaviors with respect to their bodies since cancer treatment
Other: Patient Health Questionnaire 9-Item Version
-Widely used measure that assesses mood, including an item that screens for suicidality
Experimental: Arm 3: iOTA
  • Baseline quality of life and image surveys
  • Weigh themselves everyday using the provided Balance High Accuracy Digital Body Fat Scale
  • Health coach will meet one-on-one with each participant (in-person or phone) to review health risk assessment and to choose 3 behavior goals related to healthy eating and physical activity at enrollment, 3 months, and 6 months
  • Self-monitoring via SMS text messaging. Weekly check-ins by text providing data about weight and goals
  • At the 6 month time period quality of life and body image surveys will be completed and in-office anthropometric assessments will be completed
  • At the end of 6 months, the participants will also receive the "Enhanced Usual Care Packet" which provides printed material from the American Cancer Society Website
  • At 12 month follow-up weight will be abstracted from medical record
Behavioral: Enhanced Usual Care Packets
-From the American Cancer Society Website
Other: 12-Item Short Form Health Survey
-Measures functional health and well-being from the patient's perspective
Other: International Physical Activity Questionnaire short form
-7 item scale that measures a range of physical activity from vigorous to sedentary over the last 7 days
Other: Multidimensional Body Self Relations Questionnaire - Appearance Subscales
-Gold-standard for the assessment of body image attitudes and contains 34 items
Other: Cancer-Related Body Image Scale
-13 item scale adapted from The Breast - impact of Treatment Scale, which assesses survivors' intrusive thoughts and avoidant behaviors with respect to their bodies since cancer treatment
Other: Patient Health Questionnaire 9-Item Version
-Widely used measure that assesses mood, including an item that screens for suicidality
Behavioral: iOTA
-Washington University based intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean weight loss compared between the two arms
Time Frame: Up to 12 months
-The purpose will be to obtain estimates for the size of an effect achievable by the experimental intervention in order to power and justify a full-scale trial of a weight management program in women with endometrial cancer.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ScaleDown

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea Hagemann, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201701098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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