Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)
概览
- 阶段
- 不适用
- 干预措施
- Dietitian Consultation
- 疾病 / 适应症
- GastroEsophageal Cancer
- 发起方
- H. Lee Moffitt Cancer Center and Research Institute
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Recruitment Rate- Feasibility
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.
研究者
入排标准
入选标准
- •Participants must be 18 years of age or older
- •Participants must have locally advanced or metastatic gastroesophageal cancer (GEC)
- •Participants must plan to initiate chemotherapy and/or radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt
- •Participants must be able to speak and read Spanish and/or English
- •Participants must be able to provide informed consent
排除标准
- •Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)
- •Use of feeding tubes at the time of study enrollment
研究组 & 干预措施
STRONG Intervention
Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.
干预措施: Dietitian Consultation
STRONG Intervention
Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.
干预措施: Survey
STRONG Intervention
Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.
干预措施: Fitbit Data Collection
STRONG Intervention
Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.
干预措施: Social Determinants of Health Survey (SDOH)
Usual Care Intervention
Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.
干预措施: Dietitian Consultation
Usual Care Intervention
Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.
干预措施: Survey
Usual Care Intervention
Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.
干预措施: Referral to Dietitian
结局指标
主要结局
Recruitment Rate- Feasibility
时间窗: Up to 48 Months
The Study will be deemed feasible ≥ 50% of eligible patients are enrolled.
Patient-reported outcome completion-Feasibility
时间窗: Up to 6 Months
The Study will be deemed feasible if ≥ 70% of participants enrolled submit 4 of the 6 study assessments.
Retention Rate- Feasibility
时间窗: Up to 90 Days
The Study will be deemed feasible if ≥ 70% of participants enrolled at baseline are retained at the end of the intervention period.
Patient Rating of MyPlate app-Feasibility
时间窗: Up to 6 Months
The Study will be deemed feasible if ≥ 70% of participants rate the MyPlate app as east-to use utilizing a validated usability scale (score ≥ 60).
Food Log Data Collection-Feasibility
时间窗: Up to 6 Months
The study will be deemed feasible if ≥ 70% of participants enrolled log food for greater than 80% of study days (72 out of 90).
Participant Satisfaction- Acceptability
时间窗: Up to 6 Months
Patient satisfaction with the intervention will be deemed acceptable if ≥ 70% of participants rate the intervention as satisfactory utilizing a validated 4 item scale (score range 0-20). A cutoff score of ≥ 12 based on prior studies to define intervention acceptability will be used.
Adherence to Dietitian Visits- Feasibility
时间窗: Up to 6 Months
The Study will be deemed feasible if ≥ 70% of participants enrolled attend 4 out of 6 dietitian visits.
Fidelity to Study Protocol- Feasibility
时间窗: Up to 6 Months
The Study will be deemed feasible if 20% of randomly audited dietitian visits have documented PG-SGA and calorie and protein goals
次要结局
- Malnutrition - Low Skeletal Muscle Mass(Baseline, 3 Months, 6 Months)
- Malnutrition - Low BMI(Baseline, 3 Months, 6 Months)
- Malnutrition -Nutritional Status(Baseline, 3 Months, 6 Months)
- Treatment Adherence(Baseline, 3 Months, 6 Months)
- Malnutrition-Significant weight loss(Baseline, 3 Months, 6 Months)
- Quality of Life Questionnaires(Baseline, 3 Months, 6 Months)
- Progression Free Survival (PFS)(Up to 48 Months)