Scale Down for Endometrial Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometrial Cancer, Cancer of the Endometrium

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 12 months |