Support and Nutrition Guidance for Pancreatic Cancer

(STRONG-PCS Trial)

Overseen By Kea L Turner, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Cancer metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and satisfaction of a special nutrition program for individuals with pancreatic cancer who have undergone surgery. Participants will either receive standard nutrition care or join a program offering personalized diet support, which includes using a Fitbit (a wearable activity tracking device) and a smartphone app to monitor food intake. This trial suits those diagnosed with pancreatic cancer, who have already had surgery, and are now on a regular diet. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance nutrition care for future patients.

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 prior data suggests that the Support through Remote Observation and Nutrition Guidance program is safe?

Studies have shown that nutrition counseling is generally safe for people with pancreatic cancer. A review highlights that various nutritional therapies can enhance patients’ quality of life without major side effects. Another study found that early nutritional care can even extend survival rates by a few months.

Research on using Fitbit data collection in cancer treatment also shows positive results. Wearable fitness trackers like Fitbit are easy to use and help monitor activity and health. They provide valuable information without causing harm or discomfort to patients.

Both nutrition counseling and Fitbit data collection are safe and well-tolerated options, according to past studies. These methods have supported patients without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Support and Nutrition Guidance for Pancreatic Cancer trial because it combines cutting-edge technology with personalized care. Unlike traditional treatments that focus solely on medical interventions, this approach integrates wearable technology like Fitbit to monitor patients' health data in real time. Additionally, the trial emphasizes personalized nutrition counseling, offering bi-weekly, tailor-made advice based on individual needs and progress. This novel combination of continuous health monitoring and customized dietary support could significantly enhance patient outcomes and quality of life.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that nutrition counseling can greatly improve the health of pancreatic cancer patients. Studies indicate that up to 80% of these patients experience weight loss and poor nutrition, and personalized nutrition support can help manage these problems. In this trial, participants in the STRONG-PCS Intervention arm will receive tailored nutrition counseling and use Fitbits to collect data. This allows doctors to monitor physical activity and symptoms. This technology provides a clearer picture of a patient's health and can help doctors make better care decisions. Overall, combining nutrition counseling with wearable technology offers a promising way to support patients undergoing surgery for pancreatic cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Kea Turner, PhD

Principal Investigator

Moffitt Cancer Center

Pamela Hodul, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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 can speak and read English or Spanish.

Able to provide informed consent

I had pancreatic surgery at Moffitt Cancer Center.

Exclusion Criteria

I cannot have surgery for my cancer due to its spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-Surgery Initial Consultation

Participants receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge

2 weeks

1 visit (in-person)

Nutrition Guidance and Monitoring

Participants receive bi-weekly nutrition counseling via telehealth or in person and remote monitoring through a smartphone app and wearable sensor

8 weeks

4 visits (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of malnutrition and quality of life

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fitbit Data Collection
• Nutrition Counseling
• Survey

Trial Overview 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.

How Is the Trial Designed?

Group I: STRONG-PCS Intervention Experimental Treatment 3 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 Care Active Control 2 Interventions

Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

In a study of 304 pancreatic cancer patients, 70% maintained or improved their nutritional status during treatment, which is crucial for their overall health.

Improvement in nutritional status, as measured by the Subjective Global Assessment (SGA), was linked to a significantly lower risk of mortality, with patients showing improved SGA having a 1.5 times lower risk of death compared to those with deteriorated SGA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of systematic nutritional assessment and medical nutrition therapy in pancreatic cancer. Vashi, P., Popiel, B., Lammersfeld, C., et al.[2015]

The Eat-Right Assistant (ERA) dietary assessment tool was tested on 90 women, including those of child-bearing age and pregnant or lactating women, showing it to be a reliable method for tracking dietary intake.

The study found strong correlations (0.61-0.93, mean 0.75) between ERA and traditional 24-hour dietary recalls for most nutrients, indicating that ERA can effectively assess dietary habits in the target population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Validation of an online dietary assessment tool]. Shao, Y., Luo, H., Wang, Z., et al.[2018]

The study demonstrated that the web-based dietary assessment tool Foodbook24 can effectively collect dietary intake data from Irish adults, showing similar nutrient intake ranges compared to the traditional Irish National Adult Nutrition Survey (NANS).

However, the web-based study had demographic differences, with fewer older adults and more females participating, indicating the need for targeted recruitment to ensure a representative sample for future nutrition surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respondent Characteristics and Dietary Intake Data Collected Using Web-Based and Traditional Nutrition Surveillance Approaches: Comparison and Usability Study. Timon, CM., Walton, J., Flynn, A., et al.[2021]

The National Cancer Institute has developed the ASA24 application, an automated tool for self-administered 24-hour dietary recalls, which aims to streamline dietary data collection in large-scale studies.

The ASA24 incorporates over 1,100 food probes and 10,000 pictures of food portions, making it a comprehensive resource that links food selections to nutrient databases, enhancing the accuracy and efficiency of dietary assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges in converting an interviewer-administered food probe database to self-administration in the National Cancer Institute Automated Self-administered 24-Hour Recall (ASA24). Zimmerman, TP., Hull, SG., McNutt, S., et al.[2021]

The COCO Nutritionist app, which uses speech recognition technology for dietary assessment, showed no significant difference in energy intake compared to the traditional 24-hour recall method over a 5-day period with 35 participants, indicating its potential accuracy.

This pilot study suggests that COCO could provide a lower-burden, automated approach to self-monitoring dietary intake, making it easier for users to track their nutrition effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Taylor, S., Korpusik, M., Das, S., et al.[2022]

In a study of 64 head and neck cancer patients, 43.8% were found to be malnourished or at risk of malnutrition at diagnosis, highlighting a significant concern for this patient group.

Key independent prognostic factors for malnutrition included percentage of weight loss, serum albumin levels, BMI, and the presence of symptoms like dysphagia and anorexia, indicating that these factors should be closely monitored for better patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Predict factors associated with malnutrition from patient generated subjective global assessment (PG-SGA) in head and neck cancer patients]. Arribas, L., Hurtós, L., Milà, R., et al.[2013]

The 'myfood24 Healthcare' app was found to be acceptable for both patients and healthcare professionals in a feasibility study involving 48 participants from weight management and gastroenterology surgery programs.

Compliance with the app was reasonable, with 50% of users recording their dietary intake for four or more days, indicating potential for effective dietary monitoring and support in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. Threapleton, DE., Beer, SL., Foley, DJ., et al.[2023]

In a study of 97 patients with pancreatic adenocarcinoma, systematic malnutrition screening revealed that 74.2% requested referrals to an oncology dietitian, highlighting the need for proactive nutrition interventions.

Attendance at pre-clinic information sessions significantly increased the likelihood of patients requesting referrals and attending dietitian appointments, suggesting that educational initiatives can enhance patient engagement with nutrition services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the nutrition referral system in a multidisciplinary pancreatic cancer clinic. Wong, SC., Reddy, AV., Hacker-Prietz, A., et al.[2023]

A study with 50 participants showed that high personalization in nutrition support, which included video calls with a dietitian and dietary self-monitoring, led to significantly greater improvements in diet quality compared to low personalization using only a web-based report.

Participants in the high personalization group experienced notable dietary changes, including increased intake of healthy foods and reduced consumption of energy-dense, nutrient-poor foods, highlighting the effectiveness of combining technology with personalized dietary advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact on Dietary Intake of Two Levels of Technology-Assisted Personalized Nutrition: A Randomized Trial. Rollo, ME., Haslam, RL., Collins, CE.[2021]

Patients with pancreatic cancer often experience significant weight loss and nutritional issues due to the disease's effects on digestion and treatment side effects.

Implementing standardized nutritional assessments and interventions early can help identify and manage nutritional risks, leading to fewer complications, shorter hospital stays, and improved overall well-being for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive nutritional management of the patient with pancreatic cancer. Ottery, F.[2005]

In a study of 14 patients with locally advanced pancreatic cancer undergoing chemoradiotherapy, there was a significant improvement in appetite and weight concerns, as measured by the Anorexia/Cachexia Subscale (A/CS), after 6 weeks of treatment.

Weight loss greater than 5% in the first month was linked to higher A/CS scores at 6 weeks, suggesting that maintaining nutritional status may be crucial for improving quality of life in these patients during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional status of patients with locally advanced pancreatic cancer: a pilot study. Ferrucci, LM., Bell, D., Thornton, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8114161/

Digital Biomarkers of Symptom Burden Self-Reported by ... The aim of this study was to examine whether smartphone and Fitbit data could be used to estimate daily symptom burden before and after pancreatic surgery.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04440800

Feasibility of Wearable Activity Trackers for Detection ... Wearable activity monitors to assess performance status and predict clinical outcomes in advanced cancer patients. NPJ Digit Med. 2018 Jul 5;1:27. doi ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8074869/

Predicting Outcomes in Patients Undergoing ... The objective of this study was to evaluate the utility of wearable telemonitoring technologies to predict treatment outcomes using patient activity metrics ...

4. researchgate.net researchgate.net/publication/361124288_Association_between_remotely-monitored_activity_patient-reported_outcomes_and_physical_function_in_patients_with_advanced_pancreatic_cancer

Association between remotely-monitored activity, patient ... Association between remotely-monitored activity, patient-reported outcomes, and physical function in patients with advanced pancreatic cancer.

5. healthtechmagazine.net healthtechmagazine.net/article/2018/09/cedars-sinai-uses-fitbits-better-monitor-cancer-patients-and-improve-care

Cedars-Sinai Uses Fitbits to Better Monitor Cancer Patients ... The wearables can offer an objective window into patient activity, which can translate to more accurate care.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03623464

NCT03623464 | RCT of Mobile Apps & FitBit v. Usual Care The mobile app will collect information on patients' daily physical activity patterns and health status data for clinicians using smartphone mobile technology ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7688381/

The Use of Wearables in Clinical Trials During Cancer ... The purpose of this review is to explore the use of wearables in clinical trials during cancer treatment, with a special focus on adherence.

8. npcf.us npcf.us/clinical-trials/rct-of-mobile-apps-fitbit-v-usual-care/

RCT Of Mobile Apps & FitBit V. Usual Care This is a randomized clinical trial to evaluate the use of mobile devices in preventing readmission in patients undergoing major GI cancer operations.

9. cancercenter.com cancercenter.com/community/blog/2024/05/wearable-fitness-trackers-cancer-patients

Do Wearable Fitness Trackers Help Cancer Patients? The use of wearable fitness trackers may help cancer patients and their care teams monitor activity and other vital health information.