NCT03169023已完成不适用
Scale Down: A Randomized, Controlled Weight Management Intervention for Women With Endometrial Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Mean weight loss compared between the two arms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female women 18 years of age or older and with biopsy-proven endometrial cancer.
- •BMI greater than or equal to 30 kg/m^
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm 1: ScaleDown (only first 16 patients)
Experimental
- 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
干预措施: ScaleDown (Behavioral)
Arm 1: ScaleDown (only first 16 patients)
Experimental
- 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
干预措施: Enhanced Usual Care Packets (Behavioral)
Arm 1: ScaleDown (only first 16 patients)
Experimental
- 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
干预措施: 12-Item Short Form Health Survey (Other)
Arm 1: ScaleDown (only first 16 patients)
Experimental
- 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
干预措施: International Physical Activity Questionnaire short form (Other)
Arm 1: ScaleDown (only first 16 patients)
Experimental
- 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
干预措施: Multidimensional Body Self Relations Questionnaire - Appearance Subscales (Other)
Arm 1: ScaleDown (only first 16 patients)
Experimental
- 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
干预措施: Cancer-Related Body Image Scale (Other)
Arm 1: ScaleDown (only first 16 patients)
Experimental
- 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
干预措施: Patient Health Questionnaire 9-Item Version (Other)
Arm 2: Enhanced Usual Care
Active Comparator
- 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
干预措施: Enhanced Usual Care Packets (Behavioral)
Arm 2: Enhanced Usual Care
Active Comparator
- 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
干预措施: 12-Item Short Form Health Survey (Other)
Arm 2: Enhanced Usual Care
Active Comparator
- 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
干预措施: International Physical Activity Questionnaire short form (Other)
Arm 2: Enhanced Usual Care
Active Comparator
- 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
干预措施: Multidimensional Body Self Relations Questionnaire - Appearance Subscales (Other)
Arm 2: Enhanced Usual Care
Active Comparator
- 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
干预措施: Cancer-Related Body Image Scale (Other)
Arm 2: Enhanced Usual Care
Active Comparator
- 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
干预措施: Patient Health Questionnaire 9-Item Version (Other)
Arm 3: iOTA
Experimental
- 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
干预措施: Enhanced Usual Care Packets (Behavioral)
Arm 3: iOTA
Experimental
- 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
干预措施: 12-Item Short Form Health Survey (Other)
Arm 3: iOTA
Experimental
- 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
干预措施: International Physical Activity Questionnaire short form (Other)
Arm 3: iOTA
Experimental
- 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
干预措施: Multidimensional Body Self Relations Questionnaire - Appearance Subscales (Other)
Arm 3: iOTA
Experimental
- 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
干预措施: Cancer-Related Body Image Scale (Other)
Arm 3: iOTA
Experimental
- 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
干预措施: Patient Health Questionnaire 9-Item Version (Other)
Arm 3: iOTA
Experimental
- 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
干预措施: iOTA (Behavioral)
结局指标
主要结局
Mean weight loss compared between the two arms
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (2)
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