Scale Down for Endometrial Cancer

Not Applicable

Completed

• Conditions: Cancer of the Endometrium; Endometrial Cancer
• Interventions: Behavioral: ScaleDown; Behavioral: Enhanced Usual Care Packets; Other: 12-Item Short Form Health Survey; Other: International Physical Activity Questionnaire short form; Other: Multidimensional Body Self Relations Questionnaire - Appearance Subscales; Other: Cancer-Related Body Image Scale; Other: Patient Health Questionnaire 9-Item Version; Behavioral: iOTA

• Registration Number: NCT03169023
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-21
• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Status Verified: 2019-02
• Primary Completion: 2019-02-03
• Study Completion: 2019-02-03
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 155

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: ScaleDown (only first 16 patients)	Enhanced Usual Care Packets	* 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 1: ScaleDown (only first 16 patients)	Patient Health Questionnaire 9-Item Version	* 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 2: Enhanced Usual Care	12-Item Short Form Health Survey	* 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 1: ScaleDown (only first 16 patients)	ScaleDown	* 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 1: ScaleDown (only first 16 patients)	Multidimensional Body Self Relations Questionnaire - Appearance Subscales	* 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 1: ScaleDown (only first 16 patients)	Cancer-Related Body Image Scale	* 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 1: ScaleDown (only first 16 patients)	12-Item Short Form Health Survey	* 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 1: ScaleDown (only first 16 patients)	International Physical Activity Questionnaire short form	* 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 2: Enhanced Usual Care	Enhanced Usual Care Packets	* 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 2: Enhanced Usual Care	Patient Health Questionnaire 9-Item Version	* 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 3: iOTA	Cancer-Related Body Image Scale	* 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
Arm 2: Enhanced Usual Care	Cancer-Related Body Image Scale	* 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 3: iOTA	International Physical Activity Questionnaire short form	* 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
Arm 3: iOTA	Multidimensional Body Self Relations Questionnaire - Appearance Subscales	* 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
Arm 2: Enhanced Usual Care	Multidimensional Body Self Relations Questionnaire - Appearance Subscales	* 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 3: iOTA	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
Arm 2: Enhanced Usual Care	International Physical Activity Questionnaire short form	* 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 3: iOTA	Enhanced Usual Care Packets	* 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
Arm 3: iOTA	12-Item Short Form Health Survey	* 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
Arm 3: iOTA	Patient Health Questionnaire 9-Item Version	* 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

Primary Outcome Measures

Name	Time	Method
Mean weight loss compared between the two arms	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States