NCT03449927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

February 22, 2018

Last Update Submit

March 12, 2019

Conditions

Melphalan Autologous Transplant

Keywords

Nutrition ToolMelphalan Autologous Transplant

Outcome Measures

Primary Outcomes (2)

  • Pre and post intervention mean total caloric intake

    Through count recovery (10 days)

  • Mean total protein intake

    Through count recovery (10 days)

Secondary Outcomes (2)

  • Mean daily caloric intake

    Through count recovery (10 days)

  • Mean daily protein intake

    Through count recovery (10 days)

Study Arms (2)

Control Arm: Regular menu

ACTIVE COMPARATOR

* 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 menuOther: Self report dietary intake worksheetOther: Post study questionnaire

Intervention Arm: Specialized Menu

EXPERIMENTAL

* 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: Specialized menuOther: Self report dietary intake worksheetOther: Post study questionnaire

Interventions

Specialized menuOTHER

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

Intervention Arm: Specialized Menu
Standard of care menuOTHER

-Standard registered dietitian support

Control Arm: Regular menu
Self report dietary intake worksheetOTHER

-Self report nausea and diarrhea

Control Arm: Regular menuIntervention Arm: Specialized Menu
Post study questionnaireOTHER

-Completed upon count recovery and prior to discharge

Control Arm: Regular menuIntervention Arm: Specialized Menu

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

Study Officials

  • Kathleen Stockmann, MS, RD, LD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Meaghan Ryan, MSN, FNP-BC

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

January 1, 2018

Primary Completion

February 27, 2018

Study Completion

February 27, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)