Stem Cell Transplant ComplicationsNCT04194840
Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT
A study testing physical therapy consult, Cognitive Assessment and Cancer Aging Research Group (CARG) assessment in people with Stem Cell Transplant Complications and Myeloma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stem Cell Transplant Complications, Myeloma, Lymphoma
- What is being tested?
- physical therapy consult, Cognitive Assessment and Cancer Aging Research Group (CARG) assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Those who are not felt to be candidates for autologous or allogeneic stem cell transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Pilot Study to Develop a Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing Blood and Marrow Transplantation
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.
Read the 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
- Conditions
- Stem Cell Transplant Complications, Myeloma, Lymphoma, Allogeneic and Autologous Stem Cell Transplant
- Being tested
- physical therapy consult, Cognitive Assessment, Cancer Aging Research Group (CARG) assessment, Medication Review, Nutrition assessment
- Medical subject headings
- Neoplasms, Plasma Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy consultOther
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 AssessmentOther
Montreal cognitive assessment (MoCA) and the Blessed Orientation-Memory-Concentration Test (BOMC)
Cancer Aging Research Group (CARG) assessmentOther
CARG assessment - utilized to capture information about a participant's medical history as well as functional, cognitive, and psychosocial status
Medication ReviewOther
Medication Review via Beers Assessment
Nutrition assessmentOther
Nutrition assessment Via Mini Nutrition Assessment (MNA)
Laboratory studiesOther
Laboratory studies including urine toxicology screen, C-reactive protein, albumin, pre-albumin, vitamin D
Patient satisfaction questionnaireOther
Patient satisfaction questionnaire
Physician QuestionnaireOther
Physician Questionnaire:
Questionnaire to learn about physician satisfaction with information received from reports and participant questionnaires.
Patient follow-up questionnaireOther
Patient follow-up questionnaire:
Questionnaire to learn more about participant opinions concerning the clinic and the quality of care received during visits with specialists
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 100 days after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 May 2021
- Primary completion27 Jun 2024
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda M Baer, APRN, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterBrenda H Cooper, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194840
- Sponsor's protocol ID
- CASE9Z19
- Status last verified
- Aug 2025
- First submitted
- 10 Dec 2019
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Trial does not meet criteria for IPD sharing
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Develop a Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing Blood and Marrow Transplantation
- ClinicalTrials.gov ID
- NCT04194840
- Acronym / sponsor ID
- CASE9Z19
- Conditions
- Stem Cell Transplant Complications, Myeloma, Lymphoma, Allogeneic and Autologous Stem Cell Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplant Wellness Clinic | Experimental | 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* 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Those who are not felt to be candidates for autologous or allogeneic stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical therapy consultPhysical 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 | Other | Transplant Wellness Clinic |
| Cognitive AssessmentMontreal cognitive assessment (MoCA) and the Blessed Orientation-Memory-Concentration Test (BOMC) | Other | Transplant Wellness Clinic |
| Cancer Aging Research Group (CARG) assessmentCARG assessment - utilized to capture information about a participant's medical history as well as functional, cognitive, and psychosocial status | Other | Transplant Wellness Clinic |
| Medication ReviewMedication Review via Beers Assessment | Other | Transplant Wellness Clinic |
| Nutrition assessmentNutrition assessment Via Mini Nutrition Assessment (MNA) | Other | Transplant Wellness Clinic |
| Laboratory studiesLaboratory studies including urine toxicology screen, C-reactive protein, albumin, pre-albumin, vitamin D | Other | Transplant Wellness Clinic |
| Patient satisfaction questionnairePatient satisfaction questionnaire | Other | Transplant Wellness Clinic |
| Physician QuestionnairePhysician Questionnaire: Questionnaire to learn about physician satisfaction with information received from reports and participant questionnaires. | Other | Transplant Wellness Clinic |
| Patient follow-up questionnairePatient follow-up questionnaire: Questionnaire to learn more about participant opinions concerning the clinic and the quality of care received during visits with specialists | Other | Transplant Wellness Clinic |
Primary outcome
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.
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No. Trial does not meet criteria for IPD sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda M Baer, APRN principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Brenda H Cooper, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy consult, Cognitive Assessment and Cancer Aging Research Group (CARG) assessment in people with Stem Cell Transplant Complications and Myeloma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete geriatric assessment clinic (time frame: at time of assessment (an average of 90 minutes)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.