Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

NCT ID: NCT05438927

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nutritional Support

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

Group Type EXPERIMENTAL

Fitbit Data Collection

Intervention Type BEHAVIORAL

Participants will log food intake while sharing their data with a dietician in real time for 12 weeks

Nutrition Counseling

Intervention Type BEHAVIORAL

Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth

Fact G Survey

Intervention Type BEHAVIORAL

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.

General Anxiety Disorder (GAD)-7

Intervention Type BEHAVIORAL

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.

Patient Health Questionnaire (PHQ)-9

Intervention Type BEHAVIORAL

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.

Interventions

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Fitbit Data Collection

Participants will log food intake while sharing their data with a dietician in real time for 12 weeks

Intervention Type BEHAVIORAL

Nutrition Counseling

Participants will receive individually tailored, biweekly nutrition counseling from a dietician via telehealth

Intervention Type BEHAVIORAL

Fact G Survey

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

General Anxiety Disorder (GAD)-7

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

Patient Health Questionnaire (PHQ)-9

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canopy Cancer Collective

UNKNOWN

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amir Alishahi Tabriz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Pamela Hodul, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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MCC-21795

Identifier Type: -

Identifier Source: org_study_id

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