GastroEsophageal CancerSTRONG-GECNCT05438940
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients
A study testing Fitbit Data Collection, Nutrition Counseling and Survey in people with GastroEsophageal 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 patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastroesophageal cancer who are receiving chemotherapy and radiation treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GastroEsophageal Cancer
- What is being tested?
- Fitbit Data Collection, Nutrition Counseling and Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2022to 12 Jun 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
- ≥18 years old
- Locally advanced or metastatic GEC diagnosis
- Planned to initiate chemoradiation and/or radiation therapy with a plan to have surgery or a plan to have definitive treatment at Moffitt.
- 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
- Use of feeding tubes before enrollment (The last exclusion criterion was included because investigators do not anticipate these participants would benefit from a dietary monitoring intervention)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastroesophageal cancer who are receiving chemotherapy and radiation treatment
- Conditions
- GastroEsophageal Cancer
- Being tested
- Fitbit Data Collection, Nutrition Counseling, Survey
- Keywords
- Nutrition Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Data CollectionBehavioural
Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
Nutrition CounselingBehavioural
Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth
SurveyBehavioural
Participants will take a survey at baseline and weeks 4,8,12 \& 16. (FACT-G) Questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.
| Study group | Role | What they receive |
|---|---|---|
| STRONG-GEC | Experimental | Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician. Receives: Behavioral: Fitbit Data Collection; Behavioral: Nutrition Counseling; Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate - Feasibility
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled
Measured: 12 Months
Retention Rate - Feasibility
The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks
Measured: 12 Months
Data Collection - Feasibility
The study will be deemed feasible if ≥ 60% of participants submit 3/4 study assessments
Measured: 12 Months
Participant Satisfaction - Acceptability
The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20).
Measured: 12 Months
Participant Rating on Ease of Use the Mobile Application - Usability
The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100).
Measured: 12 Months
Secondary outcomes (2)
Participant Compliance with Dietician Visit - Intervention adherence
Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician for 4/6 visits
Measured: 12 Months
Participant Compliance with Dietary Log - Intervention adherence
Intervention adherence will be deemed successful if ≥ 60% of participants track food intake for 8/12 weeks
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start15 Jul 2022
- Primary completion4 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroEsophageal 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
- 23 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kea Turner, PhD, Principal investigator, Moffitt Cancer CenterJose M Pimiento, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438940
- Sponsor's protocol ID
- MCC-21889
- Acronym
- STRONG-GEC
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2022
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lin YC, Pimiento JM, Milano J, Riccardi D, Mckinnie N, Hume E, Sprow O, Diaz-Carraway S, Budnetz M, Hagen R, Al-Jumayli M, Pereira AL, Sinnamon AJ, Somasundaram A, Permuth JB, Tabriz AA, Turner K. Feasibility trial of STRONG: A digital intervention to improve nutritional management for individuals with esophageal and gastroesophageal junction cancer. Contemp Clin Trials Commun. 2024 Dec 23;43:101421. doi: 10.1016/j.conctc.2024.101421. eCollection 2025 Feb.
PubMed 39810840
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients
- ClinicalTrials.gov ID
- NCT05438940
- Acronym / sponsor ID
- STRONG-GEC / MCC-21889
- Conditions
- GastroEsophageal Cancer
- Keywords
- Nutrition Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 30 Jun 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 patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastroesophageal cancer who are receiving chemotherapy and radiation 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-GEC | Experimental | Behavioral: Fitbit Data Collection, Behavioral: Nutrition Counseling, Behavioral: SurveyParticipants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- Locally advanced or metastatic GEC diagnosis
- Planned to initiate chemoradiation and/or radiation therapy with a plan to have surgery or a plan to have definitive treatment at Moffitt.
- Able to speak and read English
- Able to provide informed consent
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
- Use of feeding tubes before enrollment (The last exclusion criterion was included because investigators do not anticipate these participants would benefit from a dietary monitoring intervention)
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 |
|---|---|---|
| Fitbit Data CollectionParticipants will log food intake while sharing their data with a dietician in real time for 12 weeks | Behavioural | STRONG-GEC |
| Nutrition CounselingParticipants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth | Behavioural | STRONG-GEC |
| SurveyParticipants will take a survey at baseline and weeks 4,8,12 \& 16. (FACT-G) Questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life. | Behavioural | STRONG-GEC |
Primary outcome
Recruitment Rate - Feasibility
Time frame: 12 Months
The study will be deemed feasible if ≥ 50% of eligible participants are enrolled
Retention Rate - Feasibility
Time frame: 12 Months
The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks
Data Collection - Feasibility
Time frame: 12 Months
The study will be deemed feasible if ≥ 60% of participants submit 3/4 study assessments
Participant Satisfaction - Acceptability
Time frame: 12 Months
The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20).
Participant Rating on Ease of Use the Mobile Application - Usability
Time frame: 12 Months
The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100).
2 secondary outcomes
Participant Compliance with Dietician Visit - Intervention adherence
Time frame: 12 Months
Participant Compliance with Dietary Log - Intervention adherence
Time frame: 12 Months
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 30 Jul 2026.
- Derived from this study: PubMed 39810840Lin YC, Pimiento JM, Milano J, Riccardi D, Mckinnie N, Hume E, Sprow O, Diaz-Carraway S, Budnetz M, Hagen R, Al-Jumayli M, Pereira AL, Sinnamon AJ, Somasundaram A, Permuth JB, Tabriz AA, Turner K. Feasibility trial of STRONG: A digital intervention to improve nutritional management for individuals with esophageal and gastroesophageal junction cancer. Contemp Clin Trials Commun. 2024 Dec 23;43:101421. doi: 10.1016/j.conctc.2024.101421. eCollection 2025 Feb.
- Individual participant dataSharing planned: Undecided
Related trials for GastroEsophageal Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 3
A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Active, not recruitingPhase 1
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
Advanced Cancer, Advanced Malignancies
RecruitingPhase 2
A Phase II, Trial of Neoadjuvant Trastuzumab + Durvalumab + FLOT Targeted Immunochemotherapy
Gastric Cancer
RecruitingPhase 2
An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma
Gastroesophageal Junction (GEJ) Adenocarcinoma
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.
Kea Turner, PhD principal investigator
Moffitt Cancer Center
Jose M Pimiento, 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 Fitbit Data Collection, Nutrition Counseling and Survey in people with GastroEsophageal 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 5 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 30 Jul 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?
Recruitment Rate - Feasibility (time frame: 12 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05438940, which also lists 1 linked publication.
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 30 Jul 2026.