Gastrointestinal CancerNCT05649969
STRONG Program for Cancer Patients
A study testing Consultations with Moffitt Dietician, Daily Food Intake Diary with Fitbit smartphone application and Questionnaires in people with Gastrointestinal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Consultations with Moffitt Dietician, Daily Food Intake Diary with Fitbit smartphone application and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 21 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STRONG-PD: Support Through Remote Observation And Nutrition Guidance (STRONG) Program For Cancer Patients With Peritoneal Disease
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.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Consultations with Moffitt Dietician, Daily Food Intake Diary with Fitbit smartphone application, Questionnaires
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultations with Moffitt DieticianBehavioural
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 applicationBehavioural
Participants will keep a daily diary of food intake with a Fitbit smartphone application and wear a Fitbit for 12 weeks
QuestionnairesBehavioural
Participants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Consultations with Moffitt Dietician; Behavioral: Daily Food Intake Diary with Fitbit smartphone application; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Dec 2022
- Primary completion30 Nov 2023
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amir Alishahi Tabriz, MD, PhD, MPH, Principal investigator, Moffitt Cancer CenterBen Powers, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649969
- Sponsor's protocol ID
- MCC-22117
- Status last verified
- Feb 2026
- First submitted
- 6 Dec 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRONG-PD: Support Through Remote Observation And Nutrition Guidance (STRONG) Program For Cancer Patients With Peritoneal Disease
- ClinicalTrials.gov ID
- NCT05649969
- Acronym / sponsor ID
- MCC-22117
- Conditions
- Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STRONG Program | Experimental | Behavioral: Consultations with Moffitt Dietician, Behavioral: Daily Food Intake Diary with Fitbit smartphone application, Behavioral: Questionnairesthe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consultations with Moffitt DieticianParticipants will have an initial consultation with a dietician and then biweekly follow-up visits (in person or virtually) for 12 weeks. | Behavioural | STRONG Program |
| Daily Food Intake Diary with Fitbit smartphone applicationParticipants will keep a daily diary of food intake with a Fitbit smartphone application and wear a Fitbit for 12 weeks | Behavioural | STRONG Program |
| QuestionnairesParticipants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16. | Behavioural | STRONG Program |
Primary outcome
Feasibility of the STRONG Program
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Alishahi Tabriz, MD, PhD, MPH principal investigator
Moffitt Cancer Center
Ben Powers, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultations with Moffitt Dietician, Daily Food Intake Diary with Fitbit smartphone application and Questionnaires in people with Gastrointestinal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the STRONG Program (time frame: at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.