Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT

NCT04194840 | Completed

• 1 other identifier: CASE9Z19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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

• 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

Study Arms (1)

Transplant Wellness Clinic

EXPERIMENTAL

* 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

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

Interventions

physical therapy consult OTHER

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

Transplant Wellness Clinic

Cognitive Assessment OTHER

Montreal cognitive assessment (MoCA) and the Blessed Orientation-Memory-Concentration Test (BOMC)

Transplant Wellness Clinic

Cancer Aging Research Group (CARG) assessment OTHER

CARG assessment - utilized to capture information about a participant's medical history as well as functional, cognitive, and psychosocial status

Transplant Wellness Clinic

Medication Review OTHER

Medication Review via Beers Assessment

Transplant Wellness Clinic

Nutrition assessment OTHER

Nutrition assessment Via Mini Nutrition Assessment (MNA)

Transplant Wellness Clinic

Laboratory studies OTHER

Laboratory studies including urine toxicology screen, C-reactive protein, albumin, pre-albumin, vitamin D

Transplant Wellness Clinic

Patient satisfaction questionnaire OTHER

Patient satisfaction questionnaire

Transplant Wellness Clinic

Physician Questionnaire OTHER

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

Transplant Wellness Clinic

Patient follow-up questionnaire OTHER

Patient follow-up questionnaire: Questionnaire to learn more about participant opinions concerning the clinic and the quality of care received during visits with specialists

Transplant Wellness Clinic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Lymphoma

Interventions

Mental Status and Dementia Tests; Restraint, Physical; Medication Review; Nutrition Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Linda M Baer, APRN

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Brenda H Cooper, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 11, 2019
• Study Start: May 1, 2021
• Primary Completion: June 27, 2024
• Study Completion: March 28, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)