The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Retention Rate - Feasibility
研究概览
简要总结
The purpose of the study is to evaluate the feasibility and acceptability of a remote nutrition coaching and monitoring intervention during the 12-weeks of active chemotherapy for borderline resectable and locally advanced pancreatic cancer participants.
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
- •Men or women 18 years of age or more
- •Newly diagnosed, in place tumors of the pancreas
- •No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
- •Able to speak and read English
- •Able to consume food orally
- •Chemotherapy naive
- •Scheduled to receive treatment with chemotherapy
- •Able to provide verbal informed consent
排除标准
- •Women who are pregnant
- •Pancreatic cancer not the primary diagnosis
- •Patients on enteral or parental nutrition
- •Patients with metastatic pancreatic cancer
- •Patients with evidence of impeding bowel obstruction
- •Patients presenting with ascites
研究组 & 干预措施
MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response
Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires.
干预措施: NutritionCoaching (Behavioral)
Standard Usual Care
Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.
干预措施: Educational Handouts (Behavioral)
Standard Usual Care
Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.
干预措施: Follow-Up Survey (Behavioral)
Standard Usual Care
Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.
干预措施: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire (Behavioral)
MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response
Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires.
干预措施: Quality fo Life Questionnaire (FHSI) (Behavioral)
MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response
Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires.
干预措施: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire (Behavioral)
MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response
Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires.
干预措施: Vioscreen Food Frequency Questionnaire (FFQ) (Behavioral)
MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response
Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires.
干预措施: Follow-Up Survey (Behavioral)
MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response
Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires.
干预措施: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire (Behavioral)
Standard Usual Care
Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.
干预措施: Quality fo Life Questionnaire (FHSI) (Behavioral)
Standard Usual Care
Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.
干预措施: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire (Behavioral)
结局指标
主要结局
Retention Rate - Feasibility
时间窗: at 12 weeks
The study will be deemed feasible if \>/=70% of participants complete the post-intervention questionnaire
Recruitment Rate -Feasibility
时间窗: Up to 8 months
The study will be deemed feasible if \>/= 60% of eligible participants are enrolled
Adherence - Feasibility
时间窗: at 12 weeks
The study will be deemed feasible if average attendance is \>/=4 weeks of sessions (out of 6) for MONITOR arm
次要结局
- Participant intent to continue using skills- Acceptability(at 12 weeks)
- Participant Satisfaction with Overall Program- Acceptability(at 12 weeks)
- Participant perception of utility of knowledge gained - Acceptability(at 12 weeks)