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NCT Number: NCT06497569

Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer

The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Dietitian Consultation

Behavioral

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.

survey

Behavioral

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 Collection

Behavioral

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 Dietitian

Behavioral

Usual Care condition referral to a dietitian based on physician discretion.

Social Determinants of Health Survey (SDOH)

Behavioral

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).

Primary outcomes

  1. Recruitment Rate- Feasibility

    Time frame: Up to 48 Months

    The Study will be deemed feasible ≥ 50% of eligible patients are enrolled.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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

  7. 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).

  8. 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.

Secondary outcomes

  1. Malnutrition -Nutritional Status

    Time frame: Baseline, 3 Months, 6 Months

    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).

  2. Malnutrition-Significant weight loss

    Time frame: Baseline, 3 Months, 6 Months

    Significant weight loss is defined as >5% and >10% of body weight. This will be calculated based on weight obtained during clinic visits.

  3. Malnutrition - Low BMI

    Time frame: Baseline, 3 Months, 6 Months

    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.

  4. Malnutrition - Low Skeletal Muscle Mass

    Time frame: Baseline, 3 Months, 6 Months

    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.

  5. Quality of Life Questionnaires

    Time frame: Baseline, 3 Months, 6 Months

    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.

  6. Treatment Adherence

    Time frame: Baseline, 3 Months, 6 Months

    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).

  7. Progression Free Survival (PFS)

    Time frame: Up to 48 Months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Hume

CONTACT

[email protected]

813-745-6426

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 11, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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