Scale Down for Endometrial Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Endometrial Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/2/2019 |
| Start Date: | February 21, 2017 |
| End Date: | February 3, 2019 |
Scale Down: A Randomized, Controlled Weight Management Intervention for Women With 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.
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.
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.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Andrea Hagemann, M.D.
Phone: 314-362-1763
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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