Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Participant adherence to the STRONG Program
研究概览
简要总结
The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are receiving chemotherapy.
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
- •Diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer
- •Receiving chemotherapy under the guidance of Moffitt
- •Able to speak and read English
- •Able to provide informed consent
排除标准
- •Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse).
- •Undergoing concurrent treatment for a second primary GI cancer
- •ECOG status of 2 or greater
- •Use of parenteral or enteral nutrition
- •Presence of malignant ascites
研究组 & 干预措施
Group 2: Usual Care
Participants will be referred to dieticians based on clinical discretion. Participants will also be asked to wear a Fitbit for 12 weeks to passively collect data on activity level.
干预措施: Questionnaires (Behavioral)
Group 1: STRONG Intervention
The STRONG program includes consultation with a Moffit dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
干预措施: Consultations with Moffitt Dietician (Behavioral)
Group 1: STRONG Intervention
The STRONG program includes consultation with a Moffit dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
干预措施: Daily Food Intake Diary with Fitbit Smartphone application (Behavioral)
Group 1: STRONG Intervention
The STRONG program includes consultation with a Moffit dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
干预措施: Questionnaires (Behavioral)
Group 2: Usual Care
Participants will be referred to dieticians based on clinical discretion. Participants will also be asked to wear a Fitbit for 12 weeks to passively collect data on activity level.
干预措施: Consultations with Moffitt Dietician (Behavioral)
Group 2: Usual Care
Participants will be referred to dieticians based on clinical discretion. Participants will also be asked to wear a Fitbit for 12 weeks to passively collect data on activity level.
干预措施: Daily Food Intake Diary with Fitbit Smartphone application (Behavioral)
结局指标
主要结局
Participant adherence to the STRONG Program
时间窗: Up to 90 days
will be defined as ≥ 60% of patients will meet with a dietician for 4/6 dietician visits and ≥ 60% of patients will track daily food intake via a Fitbit.
Feasibility of the STRONG Program
时间窗: at 12 weeks
Feasibility of the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed using recruitment and retention rates, along with data completion rates.
Acceptability of the STRONG Program
时间窗: at 16 weeks
Acceptability of the STRONG Program measure uses 4 items to indicate participant satisfaction. The measure uses a scale of 0-5, 0 meaning the participant completely disagrees with the statements regarding intervention satisfaction and 5 indicating complete agreement with the statements regarding intervention satisfaction. The measure score ranges from 0-20 with 20 indicating the highest degree of satisfaction.
Malnutrition: Significant Weight Loss
时间窗: at 16 weeks
Significant weight loss will be defined as a loss of \>5% and \>10% of body weight over the 16 week assessment period. Weight will be measured in kg.
Malnutrition: Low BMI
时间窗: at 16 weeks
Low BMI will be calculated by combining weight (kg) and height measurements (m²) and defined as \<20kg/m² for adults \< 70 years old and \<22kg/m² for adults ≥ 70 years old over the 16 week assessment period.
Malnutrition: Low Skeletal Muscle Mass
时间窗: at 16 weeks
Low skeletal muscle mass will be calculated by estimating skeletal muscle index (SMI) by dividing the cross-sectional area of muscle in a single 'slice' from an abdominal CT scan (cm2) by stature (square of height in m²). Low SMI will be defined as ≤38.9 cm2/m2 for females and ≤55.4 for males over the 16 week assessment period.
次要结局
未报告次要终点