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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STRONG Program | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consultations with Moffitt Dietician | Behavioral | Participants will have an initial consultation with a dietician and then biweekly follow-up visits (in person or virtually) for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amir Alishahi Tabriz, MD, PhD, MPH | Moffitt Cancer Center | Principal Investigator |
| Ben Powers, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D003625 | Data Collection |
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| Daily Food Intake Diary with Fitbit smartphone application | Behavioral | Participants will keep a daily diary of food intake with a Fitbit smartphone application and wear a Fitbit for 12 weeks |
|
| Questionnaires | Behavioral | Participants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16. |
|
| D005767 |
| Gastrointestinal Diseases |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |