Clinical trial NCT04853277: Patient Reported Outcomes and Patient Education in Cellular Therapy Patients
Official title: Effect of Patient Education Regarding Emotional Stressors on Patient Reported Outcomes in Patients Undergoing Cellular Therapy (HSCT or CAR-T)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stem Cell Transplant
CAR T-Cell Transplant
CAR T-Cell Therapy
Cellular Therapy
Hematopoietic Stem Cell Transplant
HSCT
Multiple Myeloma
Leukemia
Lymphoma
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in levels of anxiety, depression, and fatigue as measured by PROMIS-29
timeFrame: Baseline (pre-transplant) and 1, 3, 6, and 12-months post-transplant/CAR-T
measure: Change in levels of anxiety, depression, and fatigue as measured by NCCN Distress Thermometer
timeFrame: Baseline (pre-transplant) and 1, 3, 6, and 12-months post-transplant/CAR-T
Secondary outcomes:
measure: Overall Survival
timeFrame: 12-months post-transplant
measure: Post-Transplant Complications
timeFrame: Day 0 (date cells are infused) to 12-months post-transplant
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References: