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Completed

NCT Number: NCT04194840

Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT

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.

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Key information

Conditions

Stem Cell Transplant Complications Allogeneic and Autologous Stem Cell Transplant Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Cognitive Assessment

Other

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

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

Medication review

Other

Medication Review via Beers Assessment

Nutrition Assessment

Other

Nutrition assessment Via Mini Nutrition Assessment (MNA)

Laboratory Studies

Other

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

Patient satisfaction Questionnaire

Other

Patient satisfaction questionnaire

Physician questionnaire

Other

Physician Questionnaire:

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

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

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Dec 11, 2019
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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