Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT

Not Applicable

Active, not recruiting

• Conditions: Myeloma; Stem Cell Transplant Complications; Lymphoma; Allogeneic and Autologous Stem Cell Transplant
• Interventions: Other: physical therapy consult; Other: Cognitive Assessment; Other: Cancer Aging Research Group (CARG) assessment; Other: Medication Review; Other: Nutrition assessment; Other: Laboratory studies; Other: Patient satisfaction questionnaire; Other: Physician Questionnaire; Other: Patient follow-up questionnaire

• Registration Number: NCT04194840
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

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 Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Study Start: 2021-05-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transplant Wellness Clinic	Cognitive Assessment	* 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
Transplant Wellness Clinic	Cancer Aging Research Group (CARG) assessment	* 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
Transplant Wellness Clinic	Patient satisfaction questionnaire	* 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
Transplant Wellness Clinic	physical therapy consult	* 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
Transplant Wellness Clinic	Medication Review	* 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
Transplant Wellness Clinic	Laboratory studies	* 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
Transplant Wellness Clinic	Patient follow-up questionnaire	* 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
Transplant Wellness Clinic	Nutrition assessment	* 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
Transplant Wellness Clinic	Physician Questionnaire	* 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

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States