Scale Down for Endometrial Cancer
Scale Down: A Randomized, Controlled Weight Management Intervention for Women With Endometrial Cancer
1 other identifier
interventional
155
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2017
CompletedFirst Submitted
Initial submission to the registry
May 25, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2019
CompletedFebruary 28, 2019
February 1, 2019
2 years
May 25, 2017
February 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Arm 1: ScaleDown (only first 16 patients)
EXPERIMENTAL* 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
ACTIVE COMPARATOR* 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
EXPERIMENTAL* 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
Interventions
-Participants receives behavioral prompts and daily feedback by text messaging with motivational instructions for specific dietary and behavior modifications
-From the American Cancer Society Website
-Measures functional health and well-being from the patient's perspective
-7 item scale that measures a range of physical activity from vigorous to sedentary over the last 7 days
-Gold-standard for the assessment of body image attitudes and contains 34 items
-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
-Widely used measure that assesses mood, including an item that screens for suicidality
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- ScaleDowncollaborator
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
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.
PMID: 34140179DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Hagemann, M.D.
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2017
First Posted
May 30, 2017
Study Start
February 21, 2017
Primary Completion
February 3, 2019
Study Completion
February 3, 2019
Last Updated
February 28, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share