Skip to main content
OpenTrials
Completed

NCT Number: NCT04853277

Patient Reported Outcomes and Patient Education in Cellular Therapy Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stem Cell Transplant Blood Protein Disorders CAR T-Cell Transplant CAR T-cell Therapy Cardiovascular Diseases Cellular Therapy HSCT Hematologic Diseases Hematopoietic Stem Cell Transplant Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education

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.

Primary outcomes

  1. Change in levels of anxiety, depression, and fatigue as measured by PROMIS-29

    Time frame: Baseline (pre-transplant) and 1, 3, 6, and 12-months post-transplant/CAR-T

    Patient-Reported Outcomes Measurement Information System (PROMIS-29) includes 29 questions for 8 categories (Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity) with a Likert scale from 1-5. Transformed scores will be used in analysis. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. For the categories measured in this study (Anxiety, Depression, and Fatigue) a higher value represents greater symptom burden, while a lower value represents lower symptom burden.

  2. Change in levels of anxiety, depression, and fatigue as measured by NCCN Distress Thermometer

    Time frame: Baseline (pre-transplant) and 1, 3, 6, and 12-months post-transplant/CAR-T

    The National Comprehensive Cancer Network (NCCN) Thermometer consists of a single-item self-report measure of psychological distress, which consists of an 11-point scale with the endpoints labeled "No distress" (0) and "Extreme distress" (10).

Secondary outcomes

  1. Overall Survival

    Time frame: 12-months post-transplant

  2. Post-Transplant Complications

    Time frame: Day 0 (date cells are infused) to 12-months post-transplant

    Post-transplant complications are defined as infections, hospitalizations, and graft versus host disease (GVHD).

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Effect of Patient Education Regarding Emotional Stressors on Patient Reported Outcomes in Patients Undergoing Cellular Therapy (HSCT or CAR-T)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2021
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.