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

Primary Purpose

Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit Data Collection
Nutrition Counseling
Survey
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Nutrition Support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STRONG-PCS Intervention

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Recruitment Rate - Feasibility
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.
Retention Rate - Feasibility
The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks.
Data Collection - Feasibility
The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days.
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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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).

Full Information

First Posted
August 14, 2023
Last Updated
August 18, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT06001268
Brief Title
Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)
Acronym
STRONG-PCS
Official Title
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
August 2027 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Nutrition Support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STRONG-PCS Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.
Intervention Type
Behavioral
Intervention Name(s)
Fitbit Data Collection
Intervention Description
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Counseling
Intervention Description
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.
Intervention Type
Behavioral
Intervention Name(s)
Survey
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Rate - Feasibility
Description
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.
Time Frame
Up to 48 months
Title
Retention Rate - Feasibility
Description
The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks.
Time Frame
at 8 weeks
Title
Data Collection - Feasibility
Description
The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days.
Time Frame
at 8 weeks
Title
Participant Satisfaction - Acceptability
Description
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
Title
Participant Rating on Ease of Use the Mobile Application - Usability
Description
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
at 8 weeks
Secondary Outcome Measure Information:
Title
Malnutrition-Significant weight loss
Description
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
90 days
Title
Malnutrition - Low BMI
Description
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
Title
Malnutrition - Low Skeletal Muscle Mass
Description
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, 30, 60 and 90 days
Title
Quality of Life
Description
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
at Baseline, 4, 8 and 12 weeks
Title
Hospital Readmissions
Description
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
30, 60 and 90 days post-hospital discharge
Title
Malnutrition -Nutritional Status
Description
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).
Time Frame
at Baseline, 30, 60 and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Hume
Phone
813-745-6426
Email
emma.hume@moffitt.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kea L Turner, PhD
Phone
813-745-5213
Email
Kea.Turner@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kea Turner, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela J Hodul, MD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Hume
Phone
813-745-6426
Email
Emma.Hume@moffitt.org
First Name & Middle Initial & Last Name & Degree
Kea L Turner, PhD, MPH, MA
First Name & Middle Initial & Last Name & Degree
Pamela J Hodul, MD
First Name & Middle Initial & Last Name & Degree
Amir Alishahi Tabriz, MD, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Brian D Gonzalez, PhD
First Name & Middle Initial & Last Name & Degree
Nate H Parker, MPH, PhD
First Name & Middle Initial & Last Name & Degree
Laurence R Gore, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.moffitt.org/clinical-trials-research/clinical-trials/
Description
Moffitt Cancer Center Clinical Trial Search

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

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