Patient Reported Outcomes and Patient Education in Cellular Therapy Patients

NCT04853277 | Completed

• 1 other identifier: STUDY02000641
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

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

  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.

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

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

  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).

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

Secondary Outcomes (2)

• Overall Survival

  12-months post-transplant

• Post-Transplant Complications

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

Study Arms (1)

Education Group

EXPERIMENTAL

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

Behavioral: Education

Interventions

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.

Education Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Leukemia; Lymphoma

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 21, 2021
• Study Start: February 7, 2021
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)