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Active, Not Recruiting

NCT Number: NCT06001268

Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)

The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are undergoing surgery.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

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
  • Diagnosis of pancreatic cancer
  • Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy, total pancreatectomy) for treatment at Moffitt Cancer Center
  • Discharged on an oral diet
  • Able to speak and read English or Spanish
  • Able to provide informed consent

Exclusion criteria

  • Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)

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, bi-weekly nutrition counseling from a dietician via telehealth or in person.

survey

Behavioral

Participants will take a survey at baseline and weeks 4,8,& 12. (FACT-G) 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.

Primary outcomes

  1. Recruitment Rate - Feasibility

    Time frame: Up to 48 months

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

  2. Retention Rate - Feasibility

    Time frame: at 8 weeks

    The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks.

  3. Data Collection - Feasibility

    Time frame: at 8 weeks

    The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days.

  4. Participant Satisfaction - Acceptability

    Time frame: at 8 weeks

    The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20, score >/= 12).

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

    Time frame: at 8 weeks

    The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100, score of >/=60).

Secondary outcomes

  1. Malnutrition-Significant weight loss

    Time frame: 90 days

    Significant weight loss is defined as >5% and >10% of body weight at 30, 60, and 90 days after discharge. This will be calculated based on weight obtained during clinic visits.

  2. Malnutrition - Low BMI

    Time frame: at Baseline, 30, 60 and 90 days

    Low BMI will be defined as <20kg/m² for individuals <70 years old and <22kg/m2 for individuals ≥70 years old. This will be calculated based on weight and height measurements from clinic visits.

  3. Malnutrition - Low Skeletal Muscle Mass

    Time frame: At baseline, 30, 60 and 90 days

    Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline and 90 days after discharge (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.9 cm2 /m2 for females and SMI ≤55.4 cm2 /m2 for males.

  4. Quality of Life

    Time frame: at Baseline, 4, 8 and 12 weeks

    Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire includes questions about the 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 score indicates a better quality of life.

  5. Hospital Readmissions

    Time frame: 30, 60 and 90 days post-hospital discharge

    Hospital readmissions will be measured using a self-reported survey item to determine whether the patient was admitted to the index hospital or another hospital after hospital discharge.

  6. Malnutrition -Nutritional Status

    Time frame: at Baseline, 30, 60 and 90 days

    Nutritional status will be measured using the Patient-Generated Subjective Global Assessment (PG-SGA) Short Form (score range: 0-35) and categorized based on a prior validation study (0-1 well nourished, 2-8 at-risk, = 9 severely malnourished).

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)

Acronym: STRONG-PCS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2023
Registry last updated
Jul 2, 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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