Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT

January 2, 2024 updated by: Case Comprehensive Cancer Center

Pilot Study to Develop a Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing Blood and Marrow Transplantation

As the average age of individuals undergoing stem cell transplant continues to increase, challenges associated with balancing the side effects of cancer treatments while also managing other medical conditions develop. Studies have shown these individuals develop more treatment related side effects and take longer to leave the hospital due to complications. The purpose of this study is to develop a multiple provider clinic that will help identify any additional needs in the more complicated and generally older transplant patient population. If needed, this clinic will recommend interventions or referrals to the appropriate specialties to the participant and the transplant physician for the participant before your transplant procedure. Examples of potential areas of improvement include a course of physical therapy, nutritional supplements, or modifications of medications, among others with the goal to make your transplant safer and to decrease length of time in the hospital.

Study Overview

Detailed Description

This is a supportive interventional study to assess frailty in at risk geriatric cancer patients undergoing stem cell transplant and to determine if specific interventions are feasible and will improve overall outcomes.

A total of 20 participants will be enrolled in this study with the first 10 participants limited to myeloma or lymphoma patients who meet eligibility criteria and are candidates for autologous transplantation. The second 10 participants enrolled will be either allogeneic or autologous stem cell transplant candidates who meet eligibility criteria.

The objectives of this study are as follows:

  • To pilot a comprehensive multidisciplinary geriatric assessment clinic.
  • To determine whether a comprehensive geriatric assessment (outside of physical therapy assessment) can be performed in a time efficient manner. The goal is to complete all questionnaires and the multidisciplinary assessments in <90 minutes.
  • To assess participant and physician satisfaction
  • To determine if interventions recommended in the clinic are achievable for each participant
  • Examples of interventions could include, medication changes, management of depression, dietary modifications, physical therapy three times a week, etc.
  • To determine if participation in the transplant wellness clinic reduces length of stay and readmission rate compared to historical controls at our institution

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Deemed candidate for autologous or allogeneic transplantation by their Stem Cell Transplant Attending Physician
  • Stem cell transplant candidates > 60 years
  • Younger patients with age adjusted HCT- CMI> 4
  • Outpatient at time of enrollment.
  • Must have at a minimum 4 weeks and a maximum of 12 weeks before anticipated start of transplant procedures, ie initiation of preparation regimen or beginning of peripheral stem cell mobilization
  • Must have transportation to outpatient appointments
  • Must be able to read and understand English to complete the required questionnaires Must be able to read and understand protocol consent

Exclusion Criteria:

- Those who are not felt to be candidates for autologous or allogeneic stem cell transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transplant Wellness Clinic
  • Physical therapy consult
  • Intake vitals
  • CARG online survey, mental status exam
  • Medication review
  • Nutrition survey
  • Social work: available on prn basis (as-needed)
  • Exit survey

Recommendations made and given to the participant and sent to the referring MD. Participant receives post clinic phone call before transplant. Referring MD receives questionnaires. Data collected depending on if participant moved forward with transplant

Patient satisfaction questionnaire
Physical therapy consult to assess physical functioning on a separate office visit prior to attending the Transplant Wellness Clinic. Full evaluation that incorporates several tools to measure the risk of falling and to assess mobility and strength
Montreal cognitive assessment (MoCA) and the Blessed Orientation-Memory-Concentration Test (BOMC)
CARG assessment - utilized to capture information about a participant's medical history as well as functional, cognitive, and psychosocial status
Medication Review via Beers Assessment
Nutrition assessment Via Mini Nutrition Assessment (MNA)
Laboratory studies including urine toxicology screen, C-reactive protein, albumin, pre-albumin, vitamin D

Physician Questionnaire:

Questionnaire to learn about physician satisfaction with information received from reports and participant questionnaires.

Patient follow-up questionnaire:

Questionnaire to learn more about participant opinions concerning the clinic and the quality of care received during visits with specialists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete geriatric assessment clinic
Time Frame: at time of assessment (an average of 90 minutes)
Time to complete geriatric assessment clinic will be collected. Feasibility will be defined if 7 or more of the first 10 patients are able to complete the geriatric assessment clinic in under 90 minutes.
at time of assessment (an average of 90 minutes)
Patient satisfaction as determined by "patient follow-up quesitonnaire"
Time Frame: at time of assessment (less than 1 hour)
Analysis of patient and physician questionnaires will be tabulated and results reported in a descriptive fashion
at time of assessment (less than 1 hour)
Physician satisfaction as determined by "physician questionnaire"
Time Frame: at time of assessment (less than 1 hour)
Analysis of patient and physician questionnaires will be tabulated and results reported in a descriptive fashion
at time of assessment (less than 1 hour)
Length of transplant stay in days
Time Frame: Assessed up to 6 months after transplant
Length of transplant stay will be collected for all participants and compared to historical controls of similar age
Assessed up to 6 months after transplant
Readmission rates
Time Frame: Up to 100 days after transplant
Readmission rates in the first 100 days post-transplant will be collected and compared to historical controls using Chi-square test
Up to 100 days after transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kirsten M Boughan, DO, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
  • Principal Investigator: Brenda H Cooper, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CASE9Z19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Trial does not meet criteria for IPD sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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