Scale Down for Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169023
• Other study ID #: 201701098
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: February 3, 2019

Study information

• Verified date: February 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: February 3, 2019
• Est. primary completion date: February 3, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of the Endometrium
• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Behavioral:
• ScaleDown
-Participants receives behavioral prompts and daily feedback by text messaging with motivational instructions for specific dietary and behavior modifications
• Enhanced Usual Care Packets
-From the American Cancer Society Website

Other:
• 12-Item Short Form Health Survey
-Measures functional health and well-being from the patient's perspective
• International Physical Activity Questionnaire short form
-7 item scale that measures a range of physical activity from vigorous to sedentary over the last 7 days
• Multidimensional Body Self Relations Questionnaire - Appearance Subscales
-Gold-standard for the assessment of body image attitudes and contains 34 items
• Cancer-Related Body Image Scale
-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
• Patient Health Questionnaire 9-Item Version
-Widely used measure that assesses mood, including an item that screens for suicidality

Behavioral:
• iOTA
-Washington University based intervention

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	ScaleDown

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine