Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT
NCT ID: NCT04194840
Last Updated: 2025-08-05
Study Results
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-05-01
2025-03-28
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
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
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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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CASE9Z19
Identifier Type: -
Identifier Source: org_study_id
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