Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194840
• Other study ID #: CASE9Z19
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Case Comprehensive Cancer Center
• Contact: Linda Baer, APRN
• Phone: 216-844-3951
• Email: Linda.baer[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Allogeneic and Autologous Stem Cell Transplant
• Lymphoma
• Myeloma
• Stem Cell Transplant Complications

Intervention

Other:
• physical therapy consult
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
• Cognitive Assessment
Montreal cognitive assessment (MoCA) and the Blessed Orientation-Memory-Concentration Test (BOMC)
• Cancer Aging Research Group (CARG) assessment
CARG assessment - utilized to capture information about a participant's medical history as well as functional, cognitive, and psychosocial status
• Medication Review
Medication Review via Beers Assessment
• Nutrition assessment
Nutrition assessment Via Mini Nutrition Assessment (MNA)
• Laboratory studies
Laboratory studies including urine toxicology screen, C-reactive protein, albumin, pre-albumin, vitamin D
• Patient satisfaction questionnaire
Patient satisfaction questionnaire
• Physician Questionnaire
Physician Questionnaire: Questionnaire to learn about physician satisfaction with information received from reports and participant questionnaires.
• Patient follow-up questionnaire
Patient follow-up questionnaire: Questionnaire to learn more about participant opinions concerning the clinic and the quality of care received during visits with specialists

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete geriatric assessment clinic	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)
Primary	Patient satisfaction as determined by "patient follow-up quesitonnaire"	Analysis of patient and physician questionnaires will be tabulated and results reported in a descriptive fashion	at time of assessment (less than 1 hour)
Primary	Physician satisfaction as determined by "physician questionnaire"	Analysis of patient and physician questionnaires will be tabulated and results reported in a descriptive fashion	at time of assessment (less than 1 hour)
Primary	Length of transplant stay in days	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
Primary	Readmission rates	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