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

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. ^{1 2 3 4 5}

Is 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. ^{5 6 7 8 9}

How 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. ^{3 4 5 10 11}

Research Team

Kea Turner, PhD

Principal Investigator

Moffitt Cancer Center

Pamela Hodul, MD

Principal Investigator

Moffitt Cancer Center

Eligibility 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 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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Nutritional status of patients with locally advanced pancreatic cancer: a pilot study. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

[Predict factors associated with malnutrition from patient generated subjective global assessment (PG-SGA) in head and neck cancer patients]. [2013]

3. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of the nutrition referral system in a multidisciplinary pancreatic cancer clinic. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Outcomes of systematic nutritional assessment and medical nutrition therapy in pancreatic cancer. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Impact on Dietary Intake of Two Levels of Technology-Assisted Personalized Nutrition: A Randomized Trial. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. [2023]

7. Canada 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. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Respondent Characteristics and Dietary Intake Data Collected Using Web-Based and Traditional Nutrition Surveillance Approaches: Comparison and Usability Study. [2021]

9. United States 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). [2021]

10. China pubmed.ncbi.nlm.nih.gov

[Validation of an online dietary assessment tool]. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

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