Moffitt Cancer Center
Tampa, Florida, 33612, United States
NCT Number: NCT06001268
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Tampa, Florida, 33612, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 48 months
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.
Time frame: at 8 weeks
The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks.
Time frame: at 8 weeks
The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
H. Lee Moffitt Cancer Center and Research Institute
Other
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)
Acronym: STRONG-PCS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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