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| Name | Class |
|---|---|
| ScaleDown | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: ScaleDown (only first 16 patients) | Experimental |
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| Arm 2: Enhanced Usual Care | Active Comparator |
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| Arm 3: iOTA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ScaleDown | Behavioral | -Participants receives behavioral prompts and daily feedback by text messaging with motivational instructions for specific dietary and behavior modifications |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Hagemann, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34140179 | Derived | Zamorano 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. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Experimental |
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| Enhanced Usual Care Packets | Behavioral | -From the American Cancer Society Website |
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| 12-Item Short Form Health Survey | Other | -Measures functional health and well-being from the patient's perspective |
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| 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 |
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| Multidimensional Body Self Relations Questionnaire - Appearance Subscales | Other | -Gold-standard for the assessment of body image attitudes and contains 34 items |
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| 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 |
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| Patient Health Questionnaire 9-Item Version | Other | -Widely used measure that assesses mood, including an item that screens for suicidality |
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| iOTA | Behavioral | -Washington University based intervention |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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