Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) Study: A Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Number of Participants Accrued (Feasibility)
研究概览
简要总结
This trial tests how well a remotely-delivered nutrition and culinary intervention works to improve diet quality among stage I-III breast cancer survivors. Despite the strong evidence demonstrating the benefits of healthy nutrition on improving cancer outcomes, most breast cancer survivors, do not meet the nutrition recommendations The use of technology in behavioral interventions is proving to be a cost-effective mode of delivering lifestyle education to promote behavior change. The Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) program is delivered through a learning management system on the Cook for Your Life platform (cookforyourlife.org). The Cook for Your Life platform is a cancer patient-facing interactive program offering free nutrition and healthy cooking information, recipes, and cooking videos that disseminate evidence-based information on nutrition and cancer survivorship. The MIND program may help improve diet quality and increase fruit and vegetable intake among stage I-III breast cancer survivors.
详细描述
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (INTERVENTION): Patients participate in the MIND program consisting of self-paced online education on nutrition, chef demo skills-building cooking, and mindfulness practice over 4 hours weekly for 6 weeks.
ARM B (WAITLIST CONTROL): Patients participate in standard of care (SOC) for 6 weeks. Patients may optionally receive access to the MIND program following the initial 6-week study period.
After completion of study intervention, patients are followed up at 12 weeks.
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
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older.
- •Previous diagnosis of stage I-III breast cancer in the past 5 years at the time of enrollment.
- •No evidence of current, recurrent or metastatic disease.
- •At least 60 days post final chemotherapy, biologic therapy, or radiation therapy and/or surgery. The following which are allowed: HER2-targeted therapies, CDK4/6 inhibitor (abemaciclib or ribociclib), endocrine therapy (aromatase inhibitors, ovarian suppression therapy, and tamoxifen), PARP inhibitors (olaparib), and bisphosphonates.
- •Access to phone for study contacts.
- •Access to smartphone, tablet, or computer and internet to attend online program.
- •Willing and able to complete all study activities after randomization, including completing surveys online, at-home, or over the telephone.
- •Able to understand and willing to sign written informed electronic (e) consent in English
- •Eastern Cooperative Oncology Group (ECOG) status of 0-
- •Participants must consume < 5 servings of fruits and vegetables per day as assessed by a brief questionnaire.
- •At the time of enrollment, women must not be pregnant or lactating or planning to become pregnant in the next 6 months.
排除标准
- 未提供
研究组 & 干预措施
Arm A (MIND program)
Patients participate in the MIND program consisting of self-paced online education on nutrition, chef demo skills-building cooking, and mindfulness practice over 4 hours weekly for 6 weeks.
干预措施: Electronic Medical Record (Other)
Arm A (MIND program)
Patients participate in the MIND program consisting of self-paced online education on nutrition, chef demo skills-building cooking, and mindfulness practice over 4 hours weekly for 6 weeks.
干预措施: Behavioral Dietary Intervention (Behavioral)
Arm A (MIND program)
Patients participate in the MIND program consisting of self-paced online education on nutrition, chef demo skills-building cooking, and mindfulness practice over 4 hours weekly for 6 weeks.
干预措施: Questionnaire Administration (Other)
Arm B (waitlist control)
Patients participate in SOC for 6 weeks. Patients may optionally receive access to the MIND program following the initial 6-week study period.
干预措施: Best Practice (Other)
Arm B (waitlist control)
Patients participate in SOC for 6 weeks. Patients may optionally receive access to the MIND program following the initial 6-week study period.
干预措施: Electronic Medical Record (Other)
Arm B (waitlist control)
Patients participate in SOC for 6 weeks. Patients may optionally receive access to the MIND program following the initial 6-week study period.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Number of Participants Accrued (Feasibility)
时间窗: Up to 12 months
Accrual of participants will be measured from date of initiating recruitment until last date of participant enrollment. Accrual will be considered feasible if enrollment goals (n=100 participants enrolled) is achieved in one year from initiation of recruitment.
Engagement (Feasibility)
时间窗: Up to 12 weeks
Will be considered feasible with if ≥ 70% of participants completing ≥ 70% of modules and attending ≥ 70% of live question and answer sessions. Baseline and demographics variables will be summarized by descriptive statistics. Binary proportions can be estimated to within 15% with 95% confidence intervals.
Retention (Feasibility)
时间窗: Up to 12 weeks
Will be considered feasible with if ≥ 70% of participants complete the week 6 food frequency questionnaire. Baseline and demographics variables will be summarized by descriptive statistics. Binary proportions can be estimated to within 15% with 95% confidence intervals.
Acceptability of Mindfulness Intervention for Nutrition in the Digital Kitchen (MIND) program
时间窗: Up to 12 weeks
Will be considered feasible with if ≥ 70% of participants state that the MIND program was acceptable, appropriate, and feasible. Baseline and demographics variables will be summarized by descriptive statistics. Binary proportions can be estimated to within 15% with 95% confidence intervals.
次要结局
- Change in Diet Quality (Healthy Eating Index-2015) Score(Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm))
- Daily servings of fruit and vegetables(Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm))
- Frequency of cooking at home(Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm))
- Anxiety(Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm))
- Depression(Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm))
- Cognitive function(Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm))
- Sleep disturbance(Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm))
- Pain interference(Baseline to 6 weeks (intervention arm) or to week 12 (waitlist control arm))