Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04194840|
Recruitment Status : Suspended (COVID-19)
First Posted : December 11, 2019
Last Update Posted : December 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stem Cell Transplant Complications Myeloma Lymphoma Allogeneic and Autologous Stem Cell Transplant||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||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pilot Study to Develop a Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing Blood and Marrow Transplantation|
|Actual Study Start Date :||May 19, 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2025|
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
Other: 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
Other: Cognitive Assessment
Montreal cognitive assessment (MoCA) and the Blessed Orientation-Memory-Concentration Test (BOMC)
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
Other: Medication Review
Medication Review via Beers Assessment
Other: Nutrition assessment
Nutrition assessment Via Mini Nutrition Assessment (MNA)
Other: Laboratory studies
Laboratory studies including urine toxicology screen, C-reactive protein, albumin, pre-albumin, vitamin D
Other: Patient satisfaction questionnaire
Patient satisfaction questionnaire
Other: Physician Questionnaire
Questionnaire to learn about physician satisfaction with information received from reports and participant questionnaires.
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194840
|United States, Ohio|
|University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|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|