STRONG Program for Cancer Patients

Gastrointestinal Cancer Clinical Trial

Official title:

STRONG-PD: Support Through Remote Observation And Nutrition Guidance (STRONG) Program For Cancer Patients With Peritoneal Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05649969
• Other study ID #: MCC-22117
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 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 nutrition support for participants living with gastrointestinal cancer who are receiving chemotherapy and surgical treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Gastrointestinal Cancer diagnosis (e.g., colon cancer, appendiceal cancer)
• Peritoneal disease diagnosis
• Received Cytoreductive Surgery and Heated Intra-Peritoneal Chemotherapy (CRS-HIPEC) for curative intent at Moffitt
• Transitioned to an oral diet post-surgery
• 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 secondary primary cancer
• Receipt of parenteral or enteral nutrition after surgery

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Behavioral:
• Consultations with Moffitt Dietician
Participants will have an initial consultation with a dietician and then biweekly follow-up visits (in person or virtually) for 12 weeks.
• Daily Food Intake Diary with Fitbit smartphone application
Participants will keep a daily diary of food intake with a Fitbit smartphone application and wear a Fitbit for 12 weeks
• Questionnaires
Participants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

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

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	The 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	Adherence to the STRONG Program	Participant adherence to the Support through Remote Observation and Nutrition Guidance (STRONG) program will be assessed by Fitbit dietary log data and dietician care visit data.	at 16 weeks
Primary	Efficacy of STRONG Program on Treatment Outcomes	Efficacy of STRONG program on treatment outcomes will be measured by reviewing the Electronic Health Record for hospital readmissions and cause of readmission	at 16 weeks

External Links

•   Moffitt Cancer Center Clinical Trials website