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Patient Reported Outcomes and Patient Education in Cellular Therapy Patients

NCT ID: NCT04853277

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-07

Study Completion Date

2023-03-29

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Education Group

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

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

Each Patient will undergo a 30 minute telephone visit with a trained Medical Provider outlining the timeline of various common emotional challenges experienced after transplant/CAR-T, as well as coping techniques. A pamphlet with information discussed will also be provided to the patient to review on their own time. The patient will have an opportunity to express any psychosocial/emotional concerns at this time.

Interventions

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Education

Each Patient will undergo a 30 minute telephone visit with a trained Medical Provider outlining the timeline of various common emotional challenges experienced after transplant/CAR-T, as well as coping techniques. A pamphlet with information discussed will also be provided to the patient to review on their own time. The patient will have an opportunity to express any psychosocial/emotional concerns at this time.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Meehan

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY02000641

Identifier Type: -

Identifier Source: org_study_id