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

NCT06497569 | Recruiting

• 1 other identifier: MCC-23230
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Keywords

Nutrition Support

Outcome Measures

Primary Outcomes (8)

• Recruitment Rate- Feasibility

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

  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.

  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.

  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).

  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.

  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

  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).

  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.

  Up to 6 Months

Secondary Outcomes (7)

• Malnutrition -Nutritional Status

  Baseline, 3 Months, 6 Months

• Malnutrition-Significant weight loss

  Baseline, 3 Months, 6 Months

• Malnutrition - Low BMI

  Baseline, 3 Months, 6 Months

• Malnutrition - Low Skeletal Muscle Mass

  Baseline, 3 Months, 6 Months

• Quality of Life Questionnaires

  Baseline, 3 Months, 6 Months

Study Arms (2)

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.

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.

Behavioral: Dietitian Consultation; Behavioral: Survey; Behavioral: Referral to Dietitian

Interventions

Referral to Dietitian BEHAVIORAL

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

Usual Care 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.

STRONG Intervention; Usual Care 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.

STRONG Intervention

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.

STRONG Intervention; Usual Care Intervention

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).

STRONG Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• United States Department of Defense: collaborator

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amir Alishahi Tabriz, MD, PhD, MPH

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Jose Pimiento, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Hume

CONTACT

813-745-6426; Emma.Hume@moffitt.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To reduce risk of bias, only assessors unaware of randomization status will be used to assess study outcomes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 11, 2024
• Study Start: July 26, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (2)