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

The Washington University

Status and phase: Completed; Phase 1

Conditions: Melphalan Autologous Transplant

Treatments: Other: Self report dietary intake worksheet; Other: Specialized menu; Other: Post study questionnaire; Other: Standard of care menu

Study type: Interventional

Funder types: Other

Identifiers

NCT03449927

201711044

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Control Arm: Regular menu

Active Comparator group

Description:

* 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

Treatment:

Other: Self report dietary intake worksheet

Other: Post study questionnaire

Other: Standard of care menu

Intervention Arm: Specialized Menu

Experimental group

Description:

* 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

Treatment:

Other: Self report dietary intake worksheet

Other: Post study questionnaire

Other: Specialized menu