- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04194840
Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT
Pilot Study to Develop a Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing Blood and Marrow Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Patient satisfaction questionnaire
- Other: physical therapy consult
- Other: Cognitive Assessment
- Other: Cancer Aging Research Group (CARG) assessment
- Other: Medication Review
- Other: Nutrition assessment
- Other: Laboratory studies
- Other: Physician Questionnaire
- Other: Patient follow-up questionnaire
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kirsten M Boughan, DO
- Phone Number: 1-800-641-2422
- Email: CTUReferral@UHhospitals.org
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Recruiting
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
-
Contact:
- Kirsten M Boughan, DO
- Phone Number: 216-844-7048
- Email: Kirsten.Boughan@UHhospitals.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transplant Wellness Clinic
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 |
Patient satisfaction questionnaire
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
Montreal cognitive assessment (MoCA) and the Blessed Orientation-Memory-Concentration Test (BOMC)
CARG assessment - utilized to capture information about a participant's medical history as well as functional, cognitive, and psychosocial status
Medication Review via Beers Assessment
Nutrition assessment Via Mini Nutrition Assessment (MNA)
Laboratory studies including urine toxicology screen, C-reactive protein, albumin, pre-albumin, vitamin D
Physician Questionnaire: Questionnaire to learn about physician satisfaction with information received from reports and participant questionnaires. Patient follow-up questionnaire: Questionnaire to learn more about participant opinions concerning the clinic and the quality of care received during visits with specialists |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at time of assessment (an average of 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
|
at time of assessment (less than 1 hour)
|
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
|
at time of assessment (less than 1 hour)
|
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
|
Assessed up to 6 months after transplant
|
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
|
Up to 100 days after transplant
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kirsten M Boughan, DO, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
- Principal Investigator: Brenda H Cooper, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CASE9Z19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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