GastroEsophageal CancerNCT06497569
Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer
A study testing Dietitian Consultation, Survey and Fitbit Data Collection in people with GastroEsophageal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients. 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?
- Dietitian Consultation, Survey and Fitbit Data Collection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jul 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants must be 18 years of age or older
- Participants must have locally advanced or metastatic gastroesophageal cancer (GEC)
- Participants must plan to initiate chemotherapy and/or radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt
- Participants must be able to speak and read Spanish and/or English
- Participants must be able to provide informed consent
Who cannot join
- Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)
- Use of feeding tubes at the time of study enrollment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Kea Turner, PhD, MPH, MA, 919-966-4432, Kea.Turner@unc.edu
Kea Turner, PhD, MPH, MA
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Emma Hume, 813-745-6426, Emma.Hume@moffitt.org
Amir Alishahi Tabriz, MD, phD, MPH
About this study
Official title: Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)
The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.
- Conditions
- GastroEsophageal Cancer
- Being tested
- Dietitian Consultation, Survey, Fitbit Data Collection, Referral to Dietitian, Social Determinants of Health Survey (SDOH)
- Keywords
- Nutrition Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietitian ConsultationBehavioural
Participants will meet with a dietitian who will provide individualized nutrition counseling and dietary goals for calorie and protein intake.
Bi-weekly, 30-minute dietitian telehealth visits will be conducted via ZOOM videoconferencing at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention.
SurveyBehavioural
Surveys will be conducted using the PG-SGA short form19-21 and a brief symptom assessment tool that captures additional nutrition-impact symptoms not captured by the PG-SGA (e.g., swallowing difficulty) measured by the FACT Esophageal and Gastric Cancer scales and the FAACT anorexia/cachexia scales 22,23 through REDCap.
Surveys are completed at the pre-intervention baseline visit and monthly during the intervention period prior to the dietitian visits (up to 90 days), and at the 4 and 6 month timepoints post-intervention.
Fitbit Data CollectionBehavioural
Participants will log food intake while sharing their data with a dietitian during the 30-minute dietitian telehealth visits at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention.
Referral to DietitianBehavioural
Usual Care condition referral to a dietitian based on physician discretion.
Social Determinants of Health Survey (SDOH)Behavioural
Participants will complete a SDOH Survey that captures individual-level factors (insurance type, preferred language, educational attainment, annual household income, digital health literacy, financial toxicity, and self-reported barriers to care [e.g., transportation]) and structural-level factors (neighborhood disadvantage, rural residence).
Digital health literacy will be measured using the validated eHEALS scale, an 8-item measure assessing confidence with finding, evaluating, and applying electronic information to inform health decision-making (score ≤ 30 indicates low literacy).
| Study group | Role | What they receive |
|---|---|---|
| STRONG Intervention | Experimental | Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days.
During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake.
Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention. Receives: Behavioral: Dietitian Consultation; Behavioral: Survey; Behavioral: Fitbit Data Collection; Behavioral: Social Determinants of Health Survey (SDOH) |
| Usual Care Intervention | Active comparator | Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention. Receives: Behavioral: Dietitian Consultation; Behavioral: Survey; Behavioral: Referral to Dietitian |
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 ≥ 50% of eligible patients are enrolled.
Measured: Up to 48 Months
Retention Rate- Feasibility
The Study will be deemed feasible if ≥ 70% of participants enrolled at baseline are retained at the end of the intervention period.
Measured: Up to 90 Days
Patient-reported outcome completion-Feasibility
The Study will be deemed feasible if ≥ 70% of participants enrolled submit 4 of the 6 study assessments.
Measured: Up to 6 Months
Food Log Data Collection-Feasibility
The study will be deemed feasible if ≥ 70% of participants enrolled log food for greater than 80% of study days (72 out of 90).
Measured: Up to 6 Months
Adherence to Dietitian Visits- Feasibility
The Study will be deemed feasible if ≥ 70% of participants enrolled attend 4 out of 6 dietitian visits.
Measured: Up to 6 Months
Fidelity to Study Protocol- Feasibility
The Study will be deemed feasible if 20% of randomly audited dietitian visits have documented PG-SGA and calorie and protein goals
Measured: Up to 6 Months
Patient Rating of MyPlate app-Feasibility
The Study will be deemed feasible if ≥ 70% of participants rate the MyPlate app as east-to use utilizing a validated usability scale (score ≥ 60).
Measured: Up to 6 Months
Participant Satisfaction- Acceptability
Patient satisfaction with the intervention will be deemed acceptable if ≥ 70% of participants rate the intervention as satisfactory utilizing a validated 4 item scale (score range 0-20).
A cutoff score of ≥ 12 based on prior studies to define intervention acceptability will be used.
Measured: Up to 6 Months
Secondary outcomes (7)
Malnutrition -Nutritional Status
Nutritional status will be measured using the Patient-Generated Subjective Global Assessment (PG-SGA) Short Form (score range: 0-35) and categorized based on a prior validation study (0-1 well nourished, 2-8 at-risk, ≥ 9 severely malnourished).
Measured: Baseline, 3 Months, 6 Months
Malnutrition-Significant weight loss
Significant weight loss is defined as >5% and >10% of body weight. This will be calculated based on weight obtained during clinic visits.
Measured: Baseline, 3 Months, 6 Months
Malnutrition - Low BMI
Low BMI will be defined as <20kg/m² for individuals <70 years old and <22kg/m2 for individuals ≥70 years old.
This will be calculated based on weight and height measurements from clinic visits.
Measured: Baseline, 3 Months, 6 Months
Malnutrition - Low Skeletal Muscle Mass
Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline, 3 months and 6 months (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.5 cm2 /m2 for females and SMI ≤52.4 cm2 /m2 for males.
Measured: Baseline, 3 Months, 6 Months
Quality of Life Questionnaires
Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Scale and the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) subscales.
(FACT-G) and (FAACT) Questionnaires include questions about the 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 score indicates a better quality of life.
Measured: Baseline, 3 Months, 6 Months
Treatment Adherence
Treatment Adherence will be measured by obtaining scheduling and electronic health record (EHR) data to estimate adherence to chemotherapy and/or radiation therapy.
Comparison of will be made of planned vs. received chemotherapy and/or radiation regimens to define 1) treatment delay (yes/no); 2) dose reduction (yes/no); and 3) treatment discontinuation (yes/no). We will also document receipt of surgery (yes/no).
Measured: Baseline, 3 Months, 6 Months
Progression Free Survival (PFS)
Progression Free Survival (PFS) status will be obtained from the cancer center registry to estimate overall survival (the time from random assignment to death from any cause) and progression-free survival (the time from random assignment to disease progression or death from any cause).
Measured: Up to 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start26 Jul 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Amir Alishahi Tabriz, MD, PhD, MPH, Principal investigator, Moffitt Cancer CenterJose Pimiento, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497569
- Sponsor's protocol ID
- MCC-23230
- Status last verified
- Mar 2026
- First submitted
- 5 Jul 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Turner K, Somasundaram A, Small BJ, Milano J, Santiago C, Sprow O, Hume E, Khajoueinejad N, McKinnie N, Pereira AL, Sinnamon A, Permuth JB, Tabriz AA, Pimiento JM. A patient-mediated implementation strategy to improve nutrition care delivery for esophageal and gastric cancer: a study protocol for a pilot randomized controlled trial. J Health Popul Nutr. 2025 Dec 28;45(1):37. doi: 10.1186/s41043-025-01208-3.
PubMed 41457289
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)
- ClinicalTrials.gov ID
- NCT06497569
- Acronym / sponsor ID
- MCC-23230
- Conditions
- GastroEsophageal Cancer
- Keywords
- Nutrition Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Jul 2024 (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 this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STRONG Intervention | Experimental | Behavioral: Dietitian Consultation, Behavioral: Survey, Behavioral: Fitbit Data Collection, Behavioral: Social Determinants of Health Survey (SDOH)Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days. During the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake. Participants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention. |
| Usual Care Intervention | Active comparator | Behavioral: Dietitian Consultation, Behavioral: Survey, Behavioral: Referral to DietitianParticipants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be 18 years of age or older
- Participants must have locally advanced or metastatic gastroesophageal cancer (GEC)
- Participants must plan to initiate chemotherapy and/or radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt
- Participants must be able to speak and read Spanish and/or English
- Participants must be able to provide informed consent
Key exclusion criteria (2 listed)
- Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)
- Use of feeding tubes at the time of study enrollment
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 |
|---|---|---|
| Dietitian ConsultationParticipants will meet with a dietitian who will provide individualized nutrition counseling and dietary goals for calorie and protein intake. Bi-weekly, 30-minute dietitian telehealth visits will be conducted via ZOOM videoconferencing at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention. | Behavioural | STRONG Intervention, Usual Care Intervention |
| SurveySurveys will be conducted using the PG-SGA short form19-21 and a brief symptom assessment tool that captures additional nutrition-impact symptoms not captured by the PG-SGA (e.g., swallowing difficulty) measured by the FACT Esophageal and Gastric Cancer scales and the FAACT anorexia/cachexia scales 22,23 through REDCap. Surveys are completed at the pre-intervention baseline visit and monthly during the intervention period prior to the dietitian visits (up to 90 days), and at the 4 and 6 month timepoints post-intervention. | Behavioural | STRONG Intervention, Usual Care Intervention |
| Fitbit Data CollectionParticipants will log food intake while sharing their data with a dietitian during the 30-minute dietitian telehealth visits at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention. | Behavioural | STRONG Intervention |
| Referral to DietitianUsual Care condition referral to a dietitian based on physician discretion. | Behavioural | Usual Care Intervention |
| Social Determinants of Health Survey (SDOH)Participants will complete a SDOH Survey that captures individual-level factors (insurance type, preferred language, educational attainment, annual household income, digital health literacy, financial toxicity, and self-reported barriers to care [e.g., transportation]) and structural-level factors (neighborhood disadvantage, rural residence). Digital health literacy will be measured using the validated eHEALS scale, an 8-item measure assessing confidence with finding, evaluating, and applying electronic information to inform health decision-making (score ≤ 30 indicates low literacy). | Behavioural | STRONG Intervention |
Primary outcome
Recruitment Rate- Feasibility
Time frame: Up to 48 Months
The Study will be deemed feasible ≥ 50% of eligible patients are enrolled.
Retention Rate- Feasibility
Time frame: Up to 90 Days
The Study will be deemed feasible if ≥ 70% of participants enrolled at baseline are retained at the end of the intervention period.
Patient-reported outcome completion-Feasibility
Time frame: Up to 6 Months
The Study will be deemed feasible if ≥ 70% of participants enrolled submit 4 of the 6 study assessments.
Food Log Data Collection-Feasibility
Time frame: Up to 6 Months
The study will be deemed feasible if ≥ 70% of participants enrolled log food for greater than 80% of study days (72 out of 90).
Adherence to Dietitian Visits- Feasibility
Time frame: Up to 6 Months
The Study will be deemed feasible if ≥ 70% of participants enrolled attend 4 out of 6 dietitian visits.
Fidelity to Study Protocol- Feasibility
Time frame: Up to 6 Months
The Study will be deemed feasible if 20% of randomly audited dietitian visits have documented PG-SGA and calorie and protein goals
Patient Rating of MyPlate app-Feasibility
Time frame: Up to 6 Months
The Study will be deemed feasible if ≥ 70% of participants rate the MyPlate app as east-to use utilizing a validated usability scale (score ≥ 60).
Participant Satisfaction- Acceptability
Time frame: Up to 6 Months
Patient satisfaction with the intervention will be deemed acceptable if ≥ 70% of participants rate the intervention as satisfactory utilizing a validated 4 item scale (score range 0-20). A cutoff score of ≥ 12 based on prior studies to define intervention acceptability will be used.
7 secondary outcomes
Malnutrition -Nutritional Status
Time frame: Baseline, 3 Months, 6 Months
Malnutrition-Significant weight loss
Time frame: Baseline, 3 Months, 6 Months
Malnutrition - Low BMI
Time frame: Baseline, 3 Months, 6 Months
Malnutrition - Low Skeletal Muscle Mass
Time frame: Baseline, 3 Months, 6 Months
Quality of Life Questionnaires
Time frame: Baseline, 3 Months, 6 Months
Treatment Adherence
Time frame: Baseline, 3 Months, 6 Months
Progression Free Survival (PFS)
Time frame: Up to 48 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 41457289Turner K, Somasundaram A, Small BJ, Milano J, Santiago C, Sprow O, Hume E, Khajoueinejad N, McKinnie N, Pereira AL, Sinnamon A, Permuth JB, Tabriz AA, Pimiento JM. A patient-mediated implementation strategy to improve nutrition care delivery for esophageal and gastric cancer: a study protocol for a pilot randomized controlled trial. J Health Popul Nutr. 2025 Dec 28;45(1):37. doi: 10.1186/s41043-025-01208-3.
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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.
Amir Alishahi Tabriz, MD, PhD, MPH principal investigator
Moffitt Cancer Center
Jose Pimiento, MD principal investigator
Moffitt Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietitian Consultation, Survey and Fitbit Data Collection in people with GastroEsophageal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites 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 2 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Hume (813-745-6426, Emma.Hume@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate- Feasibility (time frame: Up to 48 Months). The study lists 8 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 NCT06497569, 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 1 Apr 2026.