Implementation of a Nutritional Tool During Melphalan Autologous Transplant to Improve Caloric and Protein Intake

Phase 1

Completed

• Conditions: Melphalan Autologous Transplant
• Interventions: Other: Standard of care menu; Other: Specialized menu; Other: Self report dietary intake worksheet; Other: Post study questionnaire

• Registration Number: NCT03449927
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this pilot before and after interventional study is to determine if early intervention and provision of menus regarding appropriate diet choices for melphalan autologous transplant patients experiencing nausea and diarrhea will improve nutrition status and overall calorie and protein intake throughout the transplant process.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-02-22
• Primary Completion: 2018-02-27
• Study Completion: 2018-02-27
• Study First Posted: 2018-02-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients undergoing melphalan autologous transplants will be included in this study
• All patients that will be included in this pilot before and after interventional study will be inpatient on floors 5900, 6900 or 8900 of Barnes-Jewish Hospital
• Per hospital protocol, all patients who will receive a melphalan autologous transplant will be admitted and remain inpatient for the duration of the transplant process. There will be no exclusion for dietary restrictions or food allergies as the foodservice provided to patients is room service, all food allergies are noted and suitable alternatives are provided as a standard of service.
• Once a patient has been determined to meet criteria for the study, they will be approached by a member of the research team between day -2 and day 0 of transplant for consent. Patients must consent for the study by day +1 of transplant to be enrolled.

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Exclusion Criteria

• Patients <18 years of age
• Pregnant women
• Prisoners
• Patient unable to provide informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control Arm: Regular menu	Post study questionnaire	* Calorie count initiated on day +1 of transplant and ending upon count recovery * Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000) * Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea * Interventions provided for control group: standard of care, verbal or printed handouts, standard educations created by Barnes Jewish Hospital (BJH) oncology dietitians
Intervention Arm: Specialized Menu	Self report dietary intake worksheet	* Calorie count and tool provided on day +1 and ending upon count recovery * Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000) * Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea * Interventions provided for intervention group: standard of care provided by BJH oncology dietitians, tools including nausea and diarrhea menus and follow up by registered dietitian (RD) to provide additional counseling on menus as symptoms arise
Intervention Arm: Specialized Menu	Post study questionnaire	* Calorie count and tool provided on day +1 and ending upon count recovery * Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000) * Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea * Interventions provided for intervention group: standard of care provided by BJH oncology dietitians, tools including nausea and diarrhea menus and follow up by registered dietitian (RD) to provide additional counseling on menus as symptoms arise
Control Arm: Regular menu	Standard of care menu	* Calorie count initiated on day +1 of transplant and ending upon count recovery * Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000) * Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea * Interventions provided for control group: standard of care, verbal or printed handouts, standard educations created by Barnes Jewish Hospital (BJH) oncology dietitians
Control Arm: Regular menu	Self report dietary intake worksheet	* Calorie count initiated on day +1 of transplant and ending upon count recovery * Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000) * Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea * Interventions provided for control group: standard of care, verbal or printed handouts, standard educations created by Barnes Jewish Hospital (BJH) oncology dietitians
Intervention Arm: Specialized Menu	Specialized menu	* Calorie count and tool provided on day +1 and ending upon count recovery * Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000) * Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea * Interventions provided for intervention group: standard of care provided by BJH oncology dietitians, tools including nausea and diarrhea menus and follow up by registered dietitian (RD) to provide additional counseling on menus as symptoms arise

Primary Outcome Measures

Name	Time	Method
Pre and post intervention mean total caloric intake	Through count recovery (10 days)
Mean total protein intake	Through count recovery (10 days)

Secondary Outcome Measures

Name	Time	Method
Mean daily caloric intake	Through count recovery (10 days)
Mean daily protein intake	Through count recovery (10 days)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States