Clinical trial · Interventional
Scale Down for Endometrial Cancer
Scale Down: A Randomized, Controlled Weight Management Intervention for Women With Endometrial Cancer
NCT03169023CI-TRIAL-00037360completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Endometrium | Endometrial Neoplasm | PROBABILISTIC | 0.70 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 12-Item Short Form Health Survey | Other | — | UNRESOLVED |
| Cancer-Related Body Image Scale | Other | — | UNRESOLVED |
| Enhanced Usual Care Packets | Behavioral | — | UNRESOLVED |
| International Physical Activity Questionnaire short form | Other | — | UNRESOLVED |
| iOTA | Behavioral | — | UNRESOLVED |
| Multidimensional Body Self Relations Questionnaire - Appearance Subscales | Other | — | UNRESOLVED |
| Patient Health Questionnaire 9-Item Version | Other | — | UNRESOLVED |
| ScaleDown | Behavioral | — |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: ScaleDown (only first 16 patients)
- 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
- interventionNames
- 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
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: Enhanced Usual Care
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDZamorano 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 34140179