Scale Down for Endometrial Cancer
Status
Completed
Conditions
Endometrial Cancer
Cancer of the Endometrium
Treatments
Other: 12-Item Short Form Health Survey
Other: Cancer-Related Body Image Scale
Other: International Physical Activity Questionnaire short form
Behavioral: Enhanced Usual Care Packets
Other: Patient Health Questionnaire 9-Item Version
Behavioral: ScaleDown
Other: Multidimensional Body Self Relations Questionnaire - Appearance Subscales
Behavioral: iOTA
Details and patient eligibility
About
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.
Enrollment
155 patients
Sex
Female
Ages
18+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Supportive Care
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
155 participants in 3 patient groups
Arm 1: ScaleDown (only first 16 patients)
Experimental group
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
Treatment:
Other: International Physical Activity Questionnaire short form
Other: Cancer-Related Body Image Scale
Other: Patient Health Questionnaire 9-Item Version
Other: 12-Item Short Form Health Survey
Behavioral: ScaleDown
Other: Multidimensional Body Self Relations Questionnaire - Appearance Subscales
Behavioral: Enhanced Usual Care Packets
Arm 2: Enhanced Usual Care
Active Comparator group
Description:
* Baseline quality of life and image surveys
* Brief in-person counseling session by a research assistant using the Enhanced Usual Care Handouts from the American Cancer Society website which provides guidelines on healthy eating and exercise
* 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 12 month follow-up weight will be abstracted from medical record
Treatment:
Other: International Physical Activity Questionnaire short form
Other: Cancer-Related Body Image Scale
Other: Patient Health Questionnaire 9-Item Version
Other: 12-Item Short Form Health Survey
Other: Multidimensional Body Self Relations Questionnaire - Appearance Subscales
Behavioral: Enhanced Usual Care Packets
Arm 3: iOTA
Experimental group
Description:
* Baseline quality of life and image surveys
* Weigh themselves everyday using the provided Balance High Accuracy Digital Body Fat Scale
* Health coach will meet one-on-one with each participant (in-person or phone) to review health risk assessment and to choose 3 behavior goals related to healthy eating and physical activity at enrollment, 3 months, and 6 months
* Self-monitoring via SMS text messaging. Weekly check-ins by text providing data about weight and goals
* 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
* At 12 month follow-up weight will be abstracted from medical record
Treatment:
Other: International Physical Activity Questionnaire short form
Other: Cancer-Related Body Image Scale
Behavioral: iOTA
Other: Patient Health Questionnaire 9-Item Version
Other: 12-Item Short Form Health Survey
Other: Multidimensional Body Self Relations Questionnaire - Appearance Subscales
Behavioral: Enhanced Usual Care Packets
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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