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Completed

NCT Number: NCT05438927

Early Supportive Care and Nutritional Support in Adults With Pancreatic Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fitbit Data Collection

Behavioral

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

Nutrition counseling

Behavioral

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

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.

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.

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.

Primary outcomes

  1. Recruitment Rate - Feasibility

    Time frame: 12 Months

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

  2. Data Collection - Feasibility

    Time frame: 12 Months

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

  3. Participant Rating on Ease of Use for the Mobile Application - Usability

    Time frame: 12 Months

    The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake

Secondary outcomes

  1. Participant Compliance with Palliative Care Visits - Intervention Adherence

    Time frame: 12 Months

    Intervention adherence will be deemed successful if ≥ 60% of participants attend recommended palliative care visits (# of visits based on provider recommendation)

  2. Participant Compliance with Dietician Visits - Intervention Adherence

    Time frame: 12 Months

    Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician biweekly for 12 weeks

  3. Participant Compliance with Dietary Log - Intervention Adherence

    Time frame: 12 Months

    Intervention adherence will be deemed successful if ≥ 60% of participants rack food intake for 8/12 weeks

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Canopy Cancer Collective

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 30, 2022
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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