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Scale Down for Endometrial Cancer

Primary Purpose

Endometrial Cancer, Cancer of the Endometrium

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ScaleDown
Enhanced Usual Care Packets
12-Item Short Form Health Survey
International Physical Activity Questionnaire short form
Multidimensional Body Self Relations Questionnaire - Appearance Subscales
Cancer-Related Body Image Scale
Patient Health Questionnaire 9-Item Version
iOTA
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Arm 1: ScaleDown (only first 16 patients)

Arm 2: Enhanced Usual Care

Arm 3: iOTA

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Mean weight loss compared between the two arms
-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.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2017
Last Updated
February 27, 2019
Sponsor
Washington University School of Medicine
Collaborators
ScaleDown
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1. Study Identification

Unique Protocol Identification Number
NCT03169023
Brief Title
Scale Down for Endometrial Cancer
Official Title
Scale Down: A Randomized, Controlled Weight Management Intervention for Women With Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
February 3, 2019 (Actual)
Study Completion Date
February 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
ScaleDown

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Cancer of the Endometrium

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: ScaleDown (only first 16 patients)
Arm Type
Experimental
Arm Description
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
Arm Title
Arm 2: Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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
Arm Title
Arm 3: iOTA
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
ScaleDown
Intervention Description
-Participants receives behavioral prompts and daily feedback by text messaging with motivational instructions for specific dietary and behavior modifications
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care Packets
Intervention Description
-From the American Cancer Society Website
Intervention Type
Other
Intervention Name(s)
12-Item Short Form Health Survey
Intervention Description
-Measures functional health and well-being from the patient's perspective
Intervention Type
Other
Intervention Name(s)
International Physical Activity Questionnaire short form
Intervention Description
-7 item scale that measures a range of physical activity from vigorous to sedentary over the last 7 days
Intervention Type
Other
Intervention Name(s)
Multidimensional Body Self Relations Questionnaire - Appearance Subscales
Intervention Description
-Gold-standard for the assessment of body image attitudes and contains 34 items
Intervention Type
Other
Intervention Name(s)
Cancer-Related Body Image Scale
Intervention Description
-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
Intervention Type
Other
Intervention Name(s)
Patient Health Questionnaire 9-Item Version
Intervention Description
-Widely used measure that assesses mood, including an item that screens for suicidality
Intervention Type
Behavioral
Intervention Name(s)
iOTA
Intervention Description
-Washington University based intervention
Primary Outcome Measure Information:
Title
Mean weight loss compared between the two arms
Description
-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.
Time Frame
Up to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Hagemann, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34140179
Citation
Zamorano AS, Wilson EM, Liu J, Leon A, Kuroki LM, Thaker PH, McCourt CK, Fuh KC, Powell MA, Mutch DG, Evanoff BA, Colditz GA, Hagemann AR. Text-message-based behavioral weight loss for endometrial cancer survivors with obesity: A randomized controlled trial. Gynecol Oncol. 2021 Sep;162(3):770-777. doi: 10.1016/j.ygyno.2021.06.007. Epub 2021 Jun 14.
Results Reference
derived
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Scale Down for Endometrial Cancer

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