Patient Reported Outcomes and Patient Education in Cellular Therapy Patients

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04853277
Collaborator
(none)
30
1
1
23.8
1.3

Study Details

Study Description

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 symptoms they are currently having. 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. They will be provided with a pamphlet to review during the visit and on their own time 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 their 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 their post-transplant/CAR-T care at a hospital other than DHMC, surveys will be mailed to them to complete and return at the same time points.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Patient Education Regarding Emotional Stressors on Patient Reported Outcomes in Patients Undergoing Cellular Therapy (HSCT or CAR-T)
Actual Study Start Date :
Feb 7, 2021
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Education Group

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

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

  1. Overall Survival [12-months post-transplant]

  2. Post-Transplant Complications [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756

Sponsors and Collaborators

  • Dartmouth-Hitchcock Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kenneth Meehan, Staff Physician, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT04853277
Other Study ID Numbers:
  • 02000641
First Posted:
Apr 21, 2021
Last Update Posted:
Apr 21, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2021