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

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

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.

Study Overview

• Status: Completed
• Conditions: Melphalan Autologous Transplant
• Intervention / Treatment: Other: Standard of care menu; Other: Self report dietary intake worksheet; Other: Post study questionnaire; Other: Specialized menu

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm: Regular 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	Other: Standard of care menu; -Standard registered dietitian support; Other: Self report dietary intake worksheet; -Self report nausea and diarrhea; Other: Post study questionnaire; -Completed upon count recovery and prior to discharge
Experimental: Intervention Arm: 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	Other: Self report dietary intake worksheet; -Self report nausea and diarrhea; Other: Post study questionnaire; -Completed upon count recovery and prior to discharge; Other: Specialized menu; -Specialized menu that will guide participant food choices if the participant experiences nausea or diarrhea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Mean daily caloric intake	Through count recovery (10 days)
Mean daily protein intake	Through count recovery (10 days)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Barnes-Jewish Hospital
• Investigators: Principal Investigator: Kathleen Stockmann, MS, RD, LD, Washington University School of Medicine; Principal Investigator: Meaghan Ryan, MSN, FNP-BC, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): February 27, 2018
• Study Completion (Actual): February 27, 2018

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Nutrition Tool; Melphalan Autologous Transplant
• Other Study ID Numbers: 201711044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No