Gastrointestinal Cancer
Conditions
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.
Interventions
BEHAVIORALConsultations 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.
Participants will keep a daily diary of food intake with a Fitbit smartphone application and wear a Fitbit for 12 weeks
BEHAVIORALQuestionnaires
Participants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the STRONG Program | at 12 weeks | 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 | at 16 weeks | 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 | at 16 weeks | 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 | at 16 weeks | Efficacy of STRONG program on treatment outcomes will be measured by reviewing the Electronic Health Record for hospital readmissions and cause of readmission |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmir Alishahi Tabriz, MD, PhD, MPH
Moffitt Cancer Center
PRINCIPAL_INVESTIGATORBen Powers, MD
Moffitt Cancer Center
Outcome results
None listed