STRONG Program for Cancer Patients

H. Lee Moffitt Cancer Center and Research Institute10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Gastrointestinal Cancer

Interventions

Consultations with Moffitt DieticianBEHAVIORAL

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 applicationBEHAVIORAL

Participants will keep a daily diary of food intake with a Fitbit smartphone application and wear a Fitbit for 12 weeks

QuestionnairesBEHAVIORAL

Participants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: at 12 weeks

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.

Time frame: at 16 weeks

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.

Time frame: at 16 weeks

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

Time frame: at 16 weeks

Data from ClinicalTrials.gov

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