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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • 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

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
Intervention / Treatment
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

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

Washington University School of Medicine

Collaborators

ScaleDown

Investigators

  • 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)

February 21, 2017

Primary Completion (Actual)

February 3, 2019

Study Completion (Actual)

February 3, 2019

Study Registration Dates

First Submitted

May 25, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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