Daughters, (dUdes), Mothers and othErs Fighting Cancer Together
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
The purpose of this protocol is to conduct a 2-arm, single-blinded randomized controlled clinical trial (RCT) in which 56 dyads (defined as consisting of an overweight or obese cancer survivor of an obesity-related cancer and an overweight or obese "buddy" of his or her choosing) would be assigned either to a 6-month, diet- and exercise-based weight loss intervention delivered via an interactive website with tailored text messages, or to a 6-month wait-listed control group. The overall goals of the eHealth intervention are to reduce obesity and select circulating biomarkers (tumor necrosis factor alpha [TNFα], insulin, and insulin-like growth factor-1 [IGF-1]), as well as improve diet quality, physical activity, health-related quality of life (QoL), physical functioning and performance as compared to the control over the 6-month study period.
详细描述
The specific aims of this protocol are to: 1) determine whether dyads (comprised of an overweight / obese cancer survivor and an overweight / obese buddy of his or her choosing) lose significantly more weight (kg) at 6-months when assigned to the eHealth intervention compared to a wait-listed control; 2) explore between-arm differences in score changes between baseline and 6-month follow-up for other key outcomes including measures of adiposity (e.g., waist circumference [WC] and body mass index [BMI]), blood pressure, diet quality, physical activity, health-related Quality of Life (QoL), physical functioning and performance; 3) Assess the impact of the intervention on select biomarkers associated with cancer risk and progression, e.g., tumor TNFα, insulin and IGF-1; and, 4) identify predictor variables associated with program efficacy, e.g., social support, self-efficacy, risk for depression, and dyad partner (spouse, relative, friend/neighbor).
Cancer survivors and their selected "buddies" who are interested in participating will be directed to a website that describes this study in detail. If interested, they will be asked to complete an online screener requiring information on race/ethnicity, gender, state of residence and eligibility criteria. Once interested participants are assessed for eligibility, consented and enrolled, they will be asked to complete online questionnaires that assess physical activity, dietary intake, health-related quality of life, risk for depression, self-efficacy, social support and barriers to diet resources. Finally, anthropometric measures, blood pressure, physical performance and circulating biomarkers will be collected in participants' homes by visiting study staff (whom the project manager will deploy after checking for a mutually convenient time for the 2-person dyad.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessors of anthropometric, physical function, patient reported outcomes and biospecimens are blinded to arm status
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18+ for whom at least one dyad member has been diagnosed and completed curative treatment for localized renal cancer, or loco-regional ovarian, colorectal, endometrial, or female breast cancer. (Loco-regional prostate cancer survivors are also eligible but could be on active surveillance).
- •Diagnosed as overweight or obese (BMI >25 kg/m
- •Low vegetable and fruit intake (<2.5 cups day).
- •Low physical activity (<150 minutes per week).
- •English-speaking and writing.
- •Completed at least 5th grade.
- •Uses the internet and owns a mobile phone.
排除标准
- •Diagnosed with uncontrolled chronic conditions (i.e., diabetes, blood pressure, CVD, etc)
- •Diagnosed with a health conditions that precludes adherence to an unsupervised weight loss intervention (e.g., pregnancy, end-stage renal disease, etc).
- •Instructed by a physician to limit physical activity AND have paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of heart attack, congestive heart failure or pulmonary conditions that required oxygen or hospitalization within 6 months.
- •Diagnosed with other cancers (except non-malignant skin cancer), cancer recurrence or metastatic disease.
- •Resides in a skilled nursing or assisted living facility.
- •Resides more than 15 minute driving distance from dyad partner.
结局指标
主要结局
Body Weight
时间窗: 6 months
Change in measured body weight
次要结局
- Physical Activity (objective)(6 months)
- Waist Circumference(6 months)
- Physical Activity (self-reported)(6 months)
- Diet Quality(6 months)
- Physical Performance (endurance)(6 months)
- Physical Performance (lower body strength)(6 months)
- Physical Performance (agility)(6 months)
- Physical Performance (gait speed)(6 months)
- Physical Performance (Balance)(6 months)
- Self-efficacy for calorically restricted diet(6 months)
- Circulating CRP(6 months)
- Self-efficacy for increased physical activity(6 months)
- Social support for calorically restricted diet(6 months)
- Social support for increased physical activity(6 months)
- Barriers for increased physical activity(6 months)
- Circulating insulin(6 months)
- Circulating glucose(6 months)
- Circulating IL-6(6 months)
- Circulating Total Cholesterol(6 months)
- Circulating HDL Cholesterol(6 months)
- Circulating Tryglycerides(6 months)
- Circulating Adiponectin(6 months)
- Circulating Leptin(6 months)
- Duke OARS Co-Morbidity Index(6 months)
- PROMIS v.1.2 GLOBAL HEALTH(6 months)
- EQ-5D-5L(6 months)
- HEALTH / E-HEALTH LITERACY SCALE (NORMAN 2006)(6 months)
- Barriers to Eating a Healthy Low Calorie Diet(6 months)
- PROMIS Emotional Distress: Depression - Short Form 8a(6 months)
- Smoking status(6 months)
研究者
Wendy Demark-Wahnefried, PhD
Professor and Webb Endowed Chair of Nutrition Sciences, University of Alabama at Birmingham (UAB) Associate Director of Cancer Prevention and Control, O'Neal Comprehensive Cancer Center
University of Alabama at Birmingham