Support and Nutrition Guidance for Pancreatic Cancer (STRONG-PCS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Support and Nutrition Guidance for Pancreatic Cancer?
Research shows that proactive nutrition screening and intervention can improve outcomes for pancreatic cancer patients. Additionally, personalized nutrition support, including dietitian consultations and self-monitoring, has been shown to lead to significant dietary improvements, suggesting that similar approaches could benefit pancreatic cancer patients.
12345Is the use of nutrition apps and personalized dietary counseling safe for humans?
The studies reviewed did not report any safety concerns related to the use of nutrition apps or personalized dietary counseling, suggesting these interventions are generally safe for human use.
56789How does the Support and Nutrition Guidance treatment for pancreatic cancer differ from other treatments?
This treatment is unique because it focuses on proactive nutrition screening and personalized dietary support, which can improve outcomes for pancreatic cancer patients by addressing malnutrition and enhancing their ability to consume and absorb nutrients. Unlike standard treatments that may not prioritize nutrition, this approach uses systematic nutritional assessments and personalized interventions to improve patients' well-being and potentially reduce complications.
3451011Eligibility Criteria
This trial is for adults over 18 with pancreatic cancer who've had certain types of surgery at Moffitt Cancer Center and are on an oral diet. They must be able to understand English or Spanish and give informed consent. It's not for those deemed unsuitable for surgery due to advanced cancer.Inclusion Criteria
I had pancreatic surgery at Moffitt Cancer Center.
I have been diagnosed with pancreatic cancer.
I am 18 years old or older.
Exclusion Criteria
I cannot have surgery for my cancer due to its spread.
Participant Groups
The STRONG-PCS program is being tested, which includes enhanced dietician access and nutrition support using surveys, Fitbit data collection, and nutrition counseling for patients recovering from pancreatic cancer surgery.
2Treatment groups
Experimental Treatment
Active Control
Group I: STRONG-PCS InterventionExperimental Treatment3 Interventions
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.
Group II: Usual CareActive Control2 Interventions
Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Moffitt Cancer CenterTampa, FL
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
United States Department of DefenseCollaborator
References
Nutritional status of patients with locally advanced pancreatic cancer: a pilot study. [2021]Nutritional status may influence quality of life and prognosis among pancreatic cancer patients, yet few studies describe measures of nutritional status during treatment. We evaluated the nutritional status of locally advanced pancreatic cancer (LAPC) patients undergoing chemoradiotherapy who received baseline nutritional assessment and counseling.
[Predict factors associated with malnutrition from patient generated subjective global assessment (PG-SGA) in head and neck cancer patients]. [2013]Patient Generated Subjective Global Assessment (PG-SGA) is a validated tool for nutrition evaluation in patients with cancer.
Effectiveness of the nutrition referral system in a multidisciplinary pancreatic cancer clinic. [2023]Proactive nutrition screening and intervention is associated with improved outcomes for patients with pancreatic adenocarcinoma (PDAC). To better optimize nutrition amongst our PDAC population, we implemented systematic malnutrition screening in the Johns Hopkins pancreas multidisciplinary clinic (PMDC) and assessed the effectiveness of our nutrition referral system.
Outcomes of systematic nutritional assessment and medical nutrition therapy in pancreatic cancer. [2015]We investigated the nutritional and survival outcomes of medical nutrition therapy by a registered dietitian, along with support from a dedicated nutrition and metabolic support team in pancreatic cancer patients requiring enteral or parenteral nutrition.
Impact on Dietary Intake of Two Levels of Technology-Assisted Personalized Nutrition: A Randomized Trial. [2021]Advances in web and mobile technologies have created efficiencies relating to collection, analysis and interpretation of dietary intake data. This study compared the impact of two levels of nutrition support: (1) low personalization, comprising a web-based personalized nutrition feedback report generated using the Australian Eating Survey® (AES) food frequency questionnaire data; and (2) high personalization, involving structured video calls with a dietitian using the AES report plus dietary self-monitoring with text message feedback. Intake was measured at baseline and 12 weeks using the AES and diet quality using the Australian Recommended Food Score (ARFS). Fifty participants (aged 39.2 ± 12.5 years; Body Mass Index 26.4 ± 6.0 kg/m2; 86.0% female) completed baseline measures. Significant (p < 0.05) between-group differences in dietary changes favored the high personalization group for total ARFS (5.6 points (95% CI 1.3 to 10.0)) and ARFS sub-scales of meat (0.9 points (0.4 to 1.6)), vegetarian alternatives (0.8 points (0.1 to 1.4)), and dairy (1.3 points (0.3 to 2.3)). Additional significant changes in favor of the high personalization group occurred for proportion of energy intake derived from energy-dense, nutrient-poor foods (-7.2% (-13.8% to -0.5%)) and takeaway foods sub-group (-3.4% (-6.5% to 0.3%). Significant within-group changes were observed for 12 dietary variables in the high personalization group vs one variable for low personalization. A higher level of personalized support combining the AES report with one-on-one dietitian video calls and dietary self-monitoring resulted in greater dietary change compared to the AES report alone. These findings suggest nutrition-related web and mobile technologies in combination with personalized dietitian delivered advice have a greater impact compared to when used alone.
Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. [2023]Monitoring nutritional intake is of clinical value, but few existing tools offer electronic dietary recording, instant nutritional analysis, and a platform connecting healthcare teams with patients that provides timely, personalised support. This feasibility randomised controlled trial tests the usability of 'myfood24 Healthcare', a dietary assessment app and healthcare professional website, in two clinical populations. Patients were recruited from a weight management programme (n21) and from a group of gastroenterology surgery outpatients (n = 27). They were randomised into three groups: standard care, myfood24, or myfood24 + diet optimisation (automated suggestions for dietary improvement). The participants were asked to record their diet at least four times over eight weeks. During the study, healthcare professionals viewed recorded dietary information to facilitate discussions about diet and nutritional targets. The participants provided feedback on usability and acceptability. A total of 48 patients were recruited, and 16 were randomised to each of the three groups. Compliance among app users (n = 32) was reasonable, with 25 (78%) using it at least once and 16 (50%) recording intake for four days or more. Among users, the mean (standard deviation) number of days used was 14.0 (17.5), and the median (interquartile range) was six (2.5-17.0) over 2 months. Feedback questionnaires were completed by only 23 of 46 participants (50%). The mean System Usability Score (n = 16) was 59 (95% confidence interval, 48-70). Patient and healthcare professional feedback indicates a need for more user training and the improvement of some key app features such as the food search function. This feasibility study shows that myfood24 Healthcare is acceptable for patients and healthcare professionals. These data will inform app refinements and its application in a larger clinical effectiveness trial.
Use of Natural Spoken Language With Automated Mapping of Self-reported Food Intake to Food Composition Data for Low-Burden Real-time Dietary Assessment: Method Comparison Study. [2022]Self-monitoring food intake is a cornerstone of national recommendations for health, but existing apps for this purpose are burdensome for users and researchers, which limits use.
Respondent Characteristics and Dietary Intake Data Collected Using Web-Based and Traditional Nutrition Surveillance Approaches: Comparison and Usability Study. [2021]There are many constraints to conducting national food consumption surveys for national nutrition surveillance, including cost, time, and participant burden. Validated web-based dietary assessment technologies offer a potential solution to many of these constraints.
Challenges in converting an interviewer-administered food probe database to self-administration in the National Cancer Institute Automated Self-administered 24-Hour Recall (ASA24). [2021]The National Cancer Institute (NCI) is developing an automated, self-administered 24-hour dietary recall (ASA24) application to collect and code dietary intake data. The goal of the ASA24 development is to create a web-based dietary interview based on the US Department of Agriculture (USDA) Automated Multiple Pass Method (AMPM) instrument currently used in the National Health and Nutrition Examination Survey (NHANES). The ASA24 food list, detail probes, and portion probes were drawn from the AMPM instrument; portion-size pictures from Baylor College of Medicine's Food Intake Recording Software System (FIRSSt) were added; and the food code/portion code assignments were linked to the USDA Food and Nutrient Database for Dietary Studies (FNDDS). The requirements that the interview be self-administered and fully auto-coded presented several challenges as the AMPM probes and responses were linked with the FNDDS food codes and portion pictures. This linking was accomplished through a "food pathway," or the sequence of steps that leads from a respondent's initial food selection, through the AMPM probes and portion pictures, to the point at which a food code and gram weight portion size are assigned. The ASA24 interview database that accomplishes this contains more than 1,100 food probes and more than 2 million food pathways and will include about 10,000 pictures of individual foods depicting up to 8 portion sizes per food. The ASA24 will make the administration of multiple days of recalls in large-scale studies economical and feasible.
[Validation of an online dietary assessment tool]. [2018]To assess the validity of eat-right assistant( ERA) as an online dietary assessment tool.
Supportive nutritional management of the patient with pancreatic cancer. [2005]Progressive weight loss and nutritional deterioration are commonly found in the patient with pancreatic cancer. The combined effects of the central anatomic location of the pancreas, endocrine and exocrine hormonal insufficiency, and treatment toxicity place patients with pancreatic cancer at high risk for developing symptoms that affect their ability to consume and absorb adequate calories and protein. The use of standardized nutritional assessment and an algorithmic approach for nutritional intervention fosters determination of the patient's nutritional risk status early in the course of disease, fosters early detection of treatable symptoms that interfere with nutritional intake/absorption, and can assess the effect of nutritional interventions. Supportive nutritional efforts can decrease complications, shorten hospital stays, reduce costs, and improve the patient's sense of well-being.