Brief Title
Scale Down for Endometrial Cancer
Official Title
Scale Down: A Randomized, Controlled Weight Management Intervention for Women With Endometrial Cancer
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.
Study Type
Interventional
Primary Outcome
Mean weight loss compared between the two arms
Condition
Endometrial Cancer
Intervention
ScaleDown
Study Arms / Comparison Groups
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
155
Start Date
February 21, 2017
Completion Date
February 3, 2019
Primary Completion Date
February 3, 2019
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Andrea Hagemann, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03169023
Organization ID
201701098
Responsible Party
Sponsor
Study Sponsor
Washington University School of Medicine
Collaborators
ScaleDown
Study Sponsor
Andrea Hagemann, M.D., Principal Investigator, Washington University School of Medicine
Verification Date
February 2019