Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)
- Conditions
- Pancreatic Cancer
- Interventions
- Behavioral: Fitbit Data CollectionBehavioral: SurveyBehavioral: Nutrition Counseling
- Registration Number
- NCT06001268
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- ≥18 years old
- Diagnosis of pancreatic cancer
- Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy, total pancreatectomy) for treatment at Moffitt Cancer Center
- Discharged on an oral diet
- Able to speak and read English or Spanish
- Able to provide informed consent
- Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Survey Participants will be referred for nutrition counseling from a dietitian based on clinical discretion. STRONG-PCS Intervention Nutrition Counseling Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician. Usual Care Nutrition Counseling Participants will be referred for nutrition counseling from a dietitian based on clinical discretion. STRONG-PCS Intervention Fitbit Data Collection Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician. STRONG-PCS Intervention Survey Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.
- Primary Outcome Measures
Name Time Method Retention Rate - Feasibility at 8 weeks The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks.
Participant Satisfaction - Acceptability at 8 weeks 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).
Participant Rating on Ease of Use the Mobile Application - Usability at 8 weeks 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).
Data Collection - Feasibility at 8 weeks The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days.
Recruitment Rate - Feasibility Up to 48 months The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.
- Secondary Outcome Measures
Name Time Method Quality of Life at Baseline, 4, 8 and 12 weeks 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.
Malnutrition - Low BMI at Baseline, 30, 60 and 90 days 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.
Malnutrition - Low Skeletal Muscle Mass At baseline, 30, 60 and 90 days 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.
Malnutrition-Significant weight loss 90 days 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.
Hospital Readmissions 30, 60 and 90 days post-hospital discharge 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.
Malnutrition -Nutritional Status at Baseline, 30, 60 and 90 days 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).
Trial Locations
- Locations (1)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States