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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06001268
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 14, 2023
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: STRONG-PCS Intervention
    Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.
  • Active Comparator: Usual Care
    Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.

Primary Outcome Measure

Recruitment Rate - Feasibility [ Time Frame: Up to 48 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Emma Hume
[email protected]
813-745-6426
Kea L Turner, PhD, MPH, MA (PRINCIPAL_INVESTIGATOR)
Pamela J Hodul, MD (PRINCIPAL_INVESTIGATOR)
Amir Alishahi Tabriz, MD, PhD, MPH (SUB_INVESTIGATOR)
Brian D Gonzalez, PhD (SUB_INVESTIGATOR)
Nate H Parker, MPH, PhD (SUB_INVESTIGATOR)
Laurence R Gore, PhD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Moffitt Cancer Center· Tampa, FL

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