Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing BMT

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04194840
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Case Comprehensive Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Linda M Baer, APRNBrenda H Cooper, MD
Principal Investigator Affiliation	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Stem Cell Transplant Complications, Myeloma, Lymphoma, Allogeneic and Autologous Stem Cell Transplant

Additional Details

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

Arms & Interventions

Arms

Experimental: 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

Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106

Site Contact

Linda M Baer, APRN

Linda.baer@uhhospitals.org

216-844-3951

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