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Completed

NCT Number: NCT05649969

STRONG Program for Cancer Patients

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.

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Consultations with Moffitt Dietician

Behavioral

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 application

Behavioral

Participants will keep a daily diary of food intake with a Fitbit smartphone application and wear a Fitbit for 12 weeks

Questionnaires

Behavioral

Participants will complete a questionnaire electronically at baseline and again at week 4, 8, 12 and 16.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

STRONG-PD: Support Through Remote Observation And Nutrition Guidance (STRONG) Program For Cancer Patients With Peritoneal Disease

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Dec 14, 2022
Registry last updated
Feb 9, 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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