Clinical trial NCT04194840: Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT
Official title: Pilot Study to Develop a Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing Blood and Marrow Transplantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stem Cell Transplant Complications
Myeloma
Lymphoma
Allogeneic and Autologous Stem Cell Transplant
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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

Eligibility criteria: 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

Primary outcomes:
measure: Time to complete geriatric assessment clinic
timeFrame: at time of assessment (an average of 90 minutes)
measure: Patient satisfaction as determined by "patient follow-up quesitonnaire"
timeFrame: at time of assessment (less than 1 hour)
measure: Physician satisfaction as determined by "physician questionnaire"
timeFrame: at time of assessment (less than 1 hour)
measure: Length of transplant stay in days
timeFrame: Assessed up to 6 months after transplant
measure: Readmission rates
timeFrame: Up to 100 days after transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Linda M Baer, APRN
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Brenda H Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References: