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

H. Lee Moffitt Cancer Center and Research Institute

Status

Enrolling

Conditions

Pancreatic Cancer

Treatments

Behavioral: Nutrition Counseling

Behavioral: Survey

Behavioral: Fitbit Data Collection

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT06001268

MCC-22476

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

STRONG-PCS Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Fitbit Data Collection

Behavioral: Survey

Behavioral: Nutrition Counseling

Usual Care

Active Comparator group

Description:

Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.

Treatment:

Behavioral: Survey

Behavioral: Nutrition Counseling