The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are undergoing surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.
Participants will take a survey at baseline and weeks 4,8,\& 12. (FACT-G) Questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.
Moffitt Cancer Center
Tampa, Florida, United States
Recruitment Rate - Feasibility
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.
Time frame: Up to 48 months
Retention Rate - Feasibility
The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks.
Time frame: at 8 weeks
Data Collection - Feasibility
The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days.
Time frame: at 8 weeks
Participant Satisfaction - Acceptability
The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20, score \>/= 12).
Time frame: at 8 weeks
Participant Rating on Ease of Use the Mobile Application - Usability
The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100, score of \>/=60).
Time frame: at 8 weeks
Malnutrition-Significant weight loss
Significant weight loss is defined as \>5% and \>10% of body weight at 30, 60, and 90 days after discharge. This will be calculated based on weight obtained during clinic visits.
Time frame: 90 days
Malnutrition - Low BMI
Low BMI will be defined as \<20kg/m² for individuals \<70 years old and \<22kg/m2 for individuals ≥70 years old. This will be calculated based on weight and height measurements from clinic visits.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: at Baseline, 30, 60 and 90 days
Malnutrition - Low Skeletal Muscle Mass
Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline and 90 days after discharge (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.9 cm2 /m2 for females and SMI ≤55.4 cm2 /m2 for males.
Time frame: At baseline, 30, 60 and 90 days
Quality of Life
Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire includes questions about the participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher score indicates a better quality of life.
Time frame: at Baseline, 4, 8 and 12 weeks
Hospital Readmissions
Hospital readmissions will be measured using a self-reported survey item to determine whether the patient was admitted to the index hospital or another hospital after hospital discharge.
Time frame: 30, 60 and 90 days post-hospital discharge
Malnutrition -Nutritional Status
Nutritional status will be measured using the Patient-Generated Subjective Global Assessment (PG-SGA) Short Form (score range: 0-35) and categorized based on a prior validation study (0-1 well nourished, 2-8 at-risk, = 9 severely malnourished).
Time frame: at Baseline, 30, 60 and 90 days