Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)

Pancreatic Cancer Clinical Trial

— STRONG-PCS  

Official title:

Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001268
• Other study ID #: MCC-22476
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: August 2027

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Emma Hume
• Phone: 813-745-6426
• Email: emma.hume[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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

Exclusion Criteria:

• Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Behavioral:
• Fitbit Data Collection
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
• Nutrition Counseling
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.
• Survey
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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate - Feasibility	The study will be deemed feasible if = 50% of eligible participants are enrolled.	Up to 48 months
Primary	Retention Rate - Feasibility	The study will be deemed feasible if = 70% of participants enrolled at baseline will be retained at 8 weeks.	at 8 weeks
Primary	Data Collection - Feasibility	The study will be deemed feasible if = 70% of participants log food for greater than 80% of study days.	at 8 weeks
Primary	Participant Satisfaction - Acceptability	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).	at 8 weeks
Primary	Participant Rating on Ease of Use the Mobile Application - Usability	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).	at 8 weeks
Secondary	Malnutrition-Significant weight loss	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.	90 days
Secondary	Malnutrition - Low BMI	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.	at Baseline, 30, 60 and 90 days
Secondary	Malnutrition - Low Skeletal Muscle Mass	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.	At baseline, 30, 60 and 90 days
Secondary	Quality of Life	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.	at Baseline, 4, 8 and 12 weeks
Secondary	Hospital Readmissions	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.	30, 60 and 90 days post-hospital discharge
Secondary	Malnutrition -Nutritional Status	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).	at Baseline, 30, 60 and 90 days

External Links

•   Moffitt Cancer Center Clinical Trial Search