Back to resultsSTRONG Program for Cancer Patients
Primary Purpose
Gastrointestinal Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Consultations with Moffitt Dietician
Daily Food Intake Diary with Fitbit smartphone application
Questionnaires
Sponsored by
About this trial
This is an interventional supportive care trial for Gastrointestinal Cancer
Eligibility Criteria
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
Sites / Locations
- Moffitt Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STRONG Program
Arm Description
the STRONG program includes consultations with a Moffitt dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
Outcomes
Primary Outcome Measures
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.
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.
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05649969
First Posted
December 6, 2022
Last Updated
October 17, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05649969
Brief Title
STRONG Program for Cancer Patients
Official Title
STRONG-PD: Support Through Remote Observation And Nutrition Guidance (STRONG) Program For Cancer Patients With Peritoneal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STRONG Program
Arm Type
Experimental
Arm Description
the STRONG program includes consultations with a Moffitt dietician, logging intake of food daily into a food diary with a Fitbit smartphone app, and completing questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Consultations with Moffitt Dietician
Intervention Description
Participants will have an initial consultation with a dietician and then biweekly follow-up visits (in person or virtually) for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Daily Food Intake Diary with Fitbit smartphone application
Intervention Description
Participants will keep a daily diary of food intake with a Fitbit smartphone application and wear a Fitbit for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Intervention Description
Participants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16.
Primary Outcome Measure Information:
Title
Feasibility of the STRONG Program
Description
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
Title
Acceptability of the STRONG Program
Description
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
Title
Adherence to the STRONG Program
Description
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
Title
Efficacy of STRONG Program on Treatment Outcomes
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kea Turner, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ben Powers, MD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.moffitt.org/clinical-trials-research/clinical-trials/
Description
Moffitt Cancer Center Clinical Trials website
Learn more about this trial
STRONG Program for Cancer Patients
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