Patient Reported Outcomes and Patient Education in Cellular Therapy Patients

Dartmouth Health

Status: Completed

Conditions: CAR T-Cell Transplant; Multiple Myeloma; Hematopoietic Stem Cell Transplant; CAR T-Cell Therapy; Stem Cell Transplant; Lymphoma; Leukemia; HSCT; Cellular Therapy

Treatments: Behavioral: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04853277

STUDY02000641

Details and patient eligibility

About

The purpose of this research is to provide an educational visit addressing common emotional stressors involved in the transplant/CAR-T process, and determine if this added education improves levels of anxiety, depression, and fatigue after transplant/CART in comparison to people who do not receive the brief educational visit.

Full description

Individuals who decide to participate in this study, will be provided with a survey evaluating current symptoms. This survey should take approximately 10 minutes to complete.

Individuals will then be scheduled for a 30 minute telephone visit to review common emotional stressors experienced after Stem Cell Transplant/CAR-T therapy as well as strategies to help reduce these symptoms. Participants will be provided with a pamphlet to review during the visit and independently afterwards. This visit will be conducted by telephone to avoid extra travel to the hospital, and will be conducted prior to admission for Transplant/CAR-T.

Individuals will then be asked to fill out the same set of surveys at 1 month, 3 months, 6 months, and 12 months after receiving the transplant/CAR-T therapy. These surveys will be conducted during other scheduled clinic visits to avoid additional travel to the hospital.

An individual's involvement will be complete at 1 year.

If an individual receives post-transplant/CAR-T care at a hospital other than DHMC, surveys will be mailed to the participant to complete and return at the same time points.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient with an underlying hematologic disease planning to undergo an autologous or allogeneic hematopoietic stem cell transplant (HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy at Dartmouth-Hitchcock Medical Center is eligible.
• The patient must be approved for HSCT/CAR-T by the treating transplant physician.

This includes completion of their pre-treatment work up and consent as directed by the standard DHMC SOPs.

• Age >18 years, and no upper age limit

Exclusion criteria

• Any patient with medical, social, or psychological factors that would prevent the patient from cooperating with the trial and completing surveys at requested intervals.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Education Group

Experimental group

Description:

Participants will receive an educational intervention focusing on psychosocial stressors and timeline of symptoms associated with the transplant/CAR-T experience.

Treatment:

Behavioral: Education