Pilot Study of a Multigenerational Digital Lifestyle Intervention for Hispanic Female Cancer Survivors and Their Families
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percent of survivor-daughter dyads retained at post-intervention (feasibility)
研究概览
简要总结
The purpose of this study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile-phone-based) program to improve lifestyle behaviors (physical activity, dietary intake) among Hispanic female cancer survivors and adult daughters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cancer Survivor Inclusion Criteria:
- •Grandmother
- •Self-identifies as Hispanic
- •Diagnosis of breast cancer (stages I-III), endometrial or ovarian cancer (stages I-II)
- •Completed active treatment (i.e., surgery, chemotherapy, and/or radiation)
- •Body Mass Index (BMI) ≥ 25 (overweight range)
- •Engages in <150 minutes/week of moderate physical activity
- •English or Spanish speaking
- •Owns a mobile device with internet access (e.g., smartphone, tablet)
- •Lives in South Florida
- •Daughter of Cancer Survivor Inclusion Criteria:
- •Adult daughter of the identified cancer survivor (21 years of age or older)
- •Has at least 1 living child ages ≤16 years old
- •Body Mass Index (BMI) ≥ 25 (overweight range) OR engages in <150 minutes/week of moderate physical activity
- •English or Spanish speaking
- •Owns a mobile device with internet access (e.g., smartphone, tablet)
- •Lives in South Florida
- •Daughter of Cancer Survivor
排除标准
- •Has been diagnosed with distant metastatic cancer
- •Has not completed active treatment (i.e., surgery, chemotherapy, and/or radiation)
- •Has uncontrolled schizophrenia or bipolar disorder
- •Has a preexisting medical condition that precludes unsupervised physical activity (e.g., severe orthopedic conditions,wheelchair bound).
- •Cancer Survivor Exclusion Criteria:
- •Has uncontrolled schizophrenia or bipolar disorder
- •Has a preexisting medical condition that precludes unsupervised physical activity (e.g., severe orthopedic conditions, wheelchair bound)
研究组 & 干预措施
With Love, Grandma ("Con Cariño, Abuelita") Group
Cancer survivor-Daughter dyads randomized to the With Love, Grandma ("Con Cariño, Abuelita") group will access a digital lifestyle program that includes 8 modules of didactic, behavioral, and family communication/parenting/grandparenting content from smartphones over the course of 10-12 weeks.
干预措施: With Love, Grandma ("Con Cariño, Abuelita") (Behavioral)
Control Group
This group is intended to reflect typical services cancer survivors and family members receive from healthcare providers.
结局指标
主要结局
Percent of survivor-daughter dyads retained at post-intervention (feasibility)
时间窗: Up to 3 months
Calculated by percent of enrolled survivor-daughter dyads who completed post-intervention measures
Percent of modules completed by survivor-daughter dyads (acceptability)
时间窗: Up to 3 months
Calculated as number of modules completed (of 8 total modules) by survivors and daughters
次要结局
- Change in survivor and daughter physical activity as measured by the Godin Leisure Time Exercise Questionnaire(Baseline, Up to 3 months)
- Change in survivor and daughter fruit and vegetable intake as measured by the NCI All-Day Screener(Baseline, Up to 3 months)
- Change in survivor and daughter physical activity as reported in the International Physical Activity Questionnaire (IPAQ)(Baseline, Up to 3 months)
研究者
Sara StGeorge
Assistant Professor of Public Health Sciences
University of Miami Sylvester Comprehensive Cancer Center