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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05675059
• Other study ID #: MCC-22082
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• 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

• 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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Behavioral:
• Consultations with Moffitt Dietician
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
Participants will keep a daily diary of food intake with a Fitbit smartphone app and wearing a Fitbit for 12 weeks.
• Questionnaires
Participants will complete a questionnaire electronically at baseline and again at 4, 8, 12 and 16 weeks.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Pancreatic Cancer Action Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the STRONG Program	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.	at 12 weeks
Primary	Acceptability of the STRONG Program	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.	at 16 weeks
Primary	Participant adherence to the STRONG Program	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.	Up to 90 days
Primary	Malnutrition: Significant Weight Loss	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.	at 16 weeks
Primary	Malnutrition: Low BMI	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.	at 16 weeks
Primary	Malnutrition: Low Skeletal Muscle Mass	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.	at 16 weeks

External Links

•   Moffitt Cancer Center Clinical Trials website