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Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit Data Collection
Nutrition Counseling
Fact G Survey
General Anxiety Disorder (GAD)-7
Patient Health Questionnaire (PHQ)-9
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 Nutritional Support

Eligibility Criteria

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

Inclusion Criteria:

  • ≥18 years old
  • Newly diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer
  • Planning to initiate chemotherapy at Moffitt
  • Able to speak and read English
  • Able to provide informed consent

Exclusion Criteria:

  • Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
  • Undergoing concurrent treatment for a second primary GI cancer
  • ECOG status of 2 or greater
  • Receipt of chemotherapy in the past 6 months for recurrent pancreatic cancer
  • Use of parenteral or enteral nutrition
  • Presence of malignant ascites
  • The last two exclusion criteria were included because investigators do not anticipate that these patients would benefit from additional nutrition intervention.

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutritional Support

Arm Description

Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing data with a dietician

Outcomes

Primary Outcome Measures

Recruitment Rate - Feasibility
The study will be deemed feasible if ≥ 50% of eligible participants are recruited
Data Collection - Feasibility
The study will be deemed feasible if ≥ 50% of participants submit study assessments
Participant Rating on Ease of Use for 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

Secondary Outcome Measures

Participant Compliance with Palliative Care Visits - Intervention Adherence
Intervention adherence will be deemed successful if ≥ 60% of participants attend recommended palliative care visits (# of visits based on provider recommendation)
Participant Compliance with Dietician Visits - Intervention Adherence
Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician biweekly for 12 weeks
Participant Compliance with Dietary Log - Intervention Adherence
Intervention adherence will be deemed successful if ≥ 60% of participants rack food intake for 8/12 weeks

Full Information

First Posted
June 27, 2022
Last Updated
October 17, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Canopy Cancer Collective
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1. Study Identification

Unique Protocol Identification Number
NCT05438927
Brief Title
Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer
Official Title
Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Canopy Cancer Collective

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 patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition and supportive care for participants living with pancreatic cancer who are receiving chemotherapy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutritional Support
Arm Type
Experimental
Arm Description
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing data with a dietician
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, biweekly nutrition counseling from a dietician via telehealth
Intervention Type
Behavioral
Intervention Name(s)
Fact G Survey
Intervention Description
Participants will take a survey at baseline and weeks 4,8,12 & 16. The 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.
Intervention Type
Behavioral
Intervention Name(s)
General Anxiety Disorder (GAD)-7
Intervention Description
Participants will take a survey at baseline and weeks 4,8,12 & 16. The questionnaire measures participants anxiety with a scale of 0=not at all, 3=Nearly everyday.
Intervention Type
Behavioral
Intervention Name(s)
Patient Health Questionnaire (PHQ)-9
Intervention Description
Participants will take a survey at baseline and weeks 4,8,12 & 16. The questionnaire measures participants depression with a scale of 0=not at all, 3=Nearly everyday.
Primary Outcome Measure Information:
Title
Recruitment Rate - Feasibility
Description
The study will be deemed feasible if ≥ 50% of eligible participants are recruited
Time Frame
12 Months
Title
Data Collection - Feasibility
Description
The study will be deemed feasible if ≥ 50% of participants submit study assessments
Time Frame
12 Months
Title
Participant Rating on Ease of Use for 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
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Participant Compliance with Palliative Care Visits - Intervention Adherence
Description
Intervention adherence will be deemed successful if ≥ 60% of participants attend recommended palliative care visits (# of visits based on provider recommendation)
Time Frame
12 Months
Title
Participant Compliance with Dietician Visits - Intervention Adherence
Description
Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician biweekly for 12 weeks
Time Frame
12 Months
Title
Participant Compliance with Dietary Log - Intervention Adherence
Description
Intervention adherence will be deemed successful if ≥ 60% of participants rack food intake for 8/12 weeks
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥18 years old Newly diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer Planning to initiate chemotherapy under the guidance of Moffitt Able to speak and read English or Spanish Able to provide informed consent Exclusion Criteria: Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse) Undergoing concurrent treatment for a second primary GI cancer ECOG status of 2 or greater Receipt of chemotherapy in the past 6 months for recurrent pancreatic cancer Use of parenteral or enteral nutrition Presence of malignant ascites The last two exclusion criteria were included because investigators do not anticipate that these patients would benefit from additional nutrition intervention.
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 Turner, PhD
Phone
813-745-5213
Email
Kea.Turner@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kea Turner, PhD, MPH, MA
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela 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 Turner, PhD, MPH, MA
First Name & Middle Initial & Last Name & Degree
Pamela Hodul, MD
First Name & Middle Initial & Last Name & Degree
Sahana Rajasekhara, MD
First Name & Middle Initial & Last Name & Degree
James Costello, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jason Fleming, MD, FACS
First Name & Middle Initial & Last Name & Degree
Brian Gonzalez, PhD
First Name & Middle Initial & Last Name & Degree
Sarah Hoffe, MD
First Name & Middle Initial & Last Name & Degree
Dae Won Kim, MD
First Name & Middle Initial & Last Name & Degree
Richard Kim, MD
First Name & Middle Initial & Last Name & Degree
Jenny Permuth, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://moffitt.org/clinical-trials-research/clinical-trials/?gclid=EAIaIQobChMImIymzIa-9gIVAZ2GCh3uzAWJEAAYASAAEgI0ovD_BwE
Description
Moffitt Cancer Center Clinical Trials Search

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Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

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