Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

NCT05438927 | Completed

• 1 other identifier: MCC-21795
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Nutritional Support

Outcome Measures

Primary Outcomes (3)

• Recruitment Rate - Feasibility

  The study will be deemed feasible if ≥ 50% of eligible participants are recruited

  12 Months

• Data Collection - Feasibility

  The study will be deemed feasible if ≥ 50% of participants submit study assessments

  12 Months

• 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

  12 Months

Secondary Outcomes (3)

• Participant Compliance with Palliative Care Visits - Intervention Adherence

  12 Months

• Participant Compliance with Dietician Visits - Intervention Adherence

  12 Months

• Participant Compliance with Dietary Log - Intervention Adherence

  12 Months

Study Arms (1)

Nutritional Support

EXPERIMENTAL

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

Behavioral: Fitbit Data Collection; Behavioral: Nutrition Counseling; Behavioral: Fact G Survey; Behavioral: General Anxiety Disorder (GAD)-7; Behavioral: Patient Health Questionnaire (PHQ)-9

Interventions

Fact G Survey 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.

Nutritional Support

Patient Health Questionnaire (PHQ)-9 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.

Nutritional Support

Fitbit Data Collection BEHAVIORAL

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

Nutritional Support

Nutrition Counseling BEHAVIORAL

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

Nutritional Support

General Anxiety Disorder (GAD)-7 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.

Nutritional Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Canopy Cancer Collective: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials Search

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amir Alishahi Tabriz, MD, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Pamela Hodul, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: July 15, 2022
• Primary Completion: October 16, 2024
• Study Completion: September 30, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)