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Completed

NCT Number: NCT05675059

Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients

The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides enhanced dietician access and nutrition support 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 of age or older
  • Diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer
  • Receiving chemotherapy under the guidance of 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
  • Use of parenteral or enteral nutrition
  • Presence of malignant ascites

Treatment and study plan

Consultations with Moffitt Dietician

Behavioral

Participants will have an initial consultation and then biweekly follow-up visits (in-person or virtually) with a study dietician for 12 weeks.

Daily Food Intake Diary with Fitbit smartphone application

Behavioral

Participants will keep a daily diary of food intake with a Fitbit smartphone app and wearing a Fitbit for 12 weeks.

Questionnaires

Behavioral

Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.

Primary outcomes

  1. Feasibility of the STRONG Program

    Time frame: at 12 weeks

    Feasibility of the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed using recruitment and retention rates, along with data completion rates.

  2. Acceptability of the STRONG Program

    Time frame: at 16 weeks

    Acceptability of the STRONG Program measure uses 4 items to indicate participant satisfaction. The measure uses a scale of 0-5, 0 meaning the participant completely disagrees with the statements regarding intervention satisfaction and 5 indicating complete agreement with the statements regarding intervention satisfaction. The measure score ranges from 0-20 with 20 indicating the highest degree of satisfaction.

  3. Participant adherence to the STRONG Program

    Time frame: Up to 90 days

    will be defined as ≥ 60% of patients will meet with a dietician for 4/6 dietician visits and ≥ 60% of patients will track daily food intake via a Fitbit.

  4. Malnutrition: Significant Weight Loss

    Time frame: at 16 weeks

    Significant weight loss will be defined as a loss of >5% and >10% of body weight over the 16 week assessment period. Weight will be measured in kg.

  5. Malnutrition: Low BMI

    Time frame: at 16 weeks

    Low BMI will be calculated by combining weight (kg) and height measurements (m²) and defined as <20kg/m² for adults < 70 years old and <22kg/m² for adults ≥ 70 years old over the 16 week assessment period.

  6. Malnutrition: Low Skeletal Muscle Mass

    Time frame: at 16 weeks

    Low skeletal muscle mass will be calculated by estimating skeletal muscle index (SMI) by dividing the cross-sectional area of muscle in a single 'slice' from an abdominal CT scan (cm2) by stature (square of height in m²). Low SMI will be defined as ≤38.9 cm2/m2 for females and ≤55.4 for males over the 16 week assessment period.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Pancreatic Cancer Action Network

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 9, 2023
Registry last updated
Jul 30, 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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