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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-02-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Melphalan Autologous Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Standard of care menu

Intervention Type OTHER

-Standard registered dietitian support

Self report dietary intake worksheet

Intervention Type OTHER

-Self report nausea and diarrhea

Post study questionnaire

Intervention Type OTHER

-Completed upon count recovery and prior to discharge

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

Group Type EXPERIMENTAL

Specialized menu

Intervention Type OTHER

-Specialized menu that will guide participant food choices if the participant experiences nausea or diarrhea

Self report dietary intake worksheet

Intervention Type OTHER

-Self report nausea and diarrhea

Post study questionnaire

Intervention Type OTHER

-Completed upon count recovery and prior to discharge

Interventions

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Specialized menu

-Specialized menu that will guide participant food choices if the participant experiences nausea or diarrhea

Intervention Type OTHER

Standard of care menu

-Standard registered dietitian support

Intervention Type OTHER

Self report dietary intake worksheet

-Self report nausea and diarrhea

Intervention Type OTHER

Post study questionnaire

-Completed upon count recovery and prior to discharge

Intervention Type OTHER

Eligibility Criteria

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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.