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Completed

NCT Number: NCT03169023

Scale Down for Endometrial Cancer

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.

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Key information

Conditions

Endometrial Cancer Cancer of the Endometrium Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ScaleDown

Behavioral

-Participants receives behavioral prompts and daily feedback by text messaging with motivational instructions for specific dietary and behavior modifications

Enhanced Usual Care Packets

Behavioral

-From the American Cancer Society Website

12-Item Short Form Health Survey

Other

-Measures functional health and well-being from the patient's perspective

International Physical Activity Questionnaire short form

Other

-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

Other

-Gold-standard for the assessment of body image attitudes and contains 34 items

Cancer-Related Body Image Scale

Other

-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

Other

-Widely used measure that assesses mood, including an item that screens for suicidality

iOTA

Behavioral

-Washington University based intervention

Primary outcomes

  1. Mean weight loss compared between the two arms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • ScaleDown

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 30, 2017
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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