Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT

NCT ID: NCT04194840

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2025-03-28

Brief Summary

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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

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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

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

physical therapy consult

Intervention Type 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

Intervention Type OTHER

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

Cancer Aging Research Group (CARG) assessment

Intervention Type OTHER

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

Medication Review

Intervention Type OTHER

Medication Review via Beers Assessment

Nutrition assessment

Intervention Type OTHER

Nutrition assessment Via Mini Nutrition Assessment (MNA)

Laboratory studies

Intervention Type OTHER

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

Patient satisfaction questionnaire

Intervention Type OTHER

Patient satisfaction questionnaire

Physician Questionnaire

Intervention Type OTHER

Physician Questionnaire:

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

Patient follow-up questionnaire

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Cognitive Assessment

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

Intervention Type OTHER

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

Intervention Type OTHER

Medication Review

Medication Review via Beers Assessment

Intervention Type OTHER

Nutrition assessment

Nutrition assessment Via Mini Nutrition Assessment (MNA)

Intervention Type OTHER

Laboratory studies

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

Intervention Type OTHER

Patient satisfaction questionnaire

Patient satisfaction questionnaire

Intervention Type OTHER

Physician Questionnaire

Physician Questionnaire:

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda M Baer, APRN

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Brenda H Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Locations

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University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CASE9Z19

Identifier Type: -

Identifier Source: org_study_id

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