Patient Reported Outcomes and Patient Education in Cellular Therapy Patients
Primary Purpose
Stem Cell Transplant, CAR T-Cell Transplant, CAR T-Cell Therapy
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education
Sponsored by
About this trial
This is an interventional prevention trial for Stem Cell Transplant
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.
Sites / Locations
- Dartmouth-Hitchcock Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Education Group
Arm Description
Participants will receive an educational intervention focusing on psychosocial stressors and timeline of symptoms associated with the transplant/CAR-T experience.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Overall Survival
Post-Transplant Complications
Post-transplant complications are defined as infections, hospitalizations, and graft versus host disease (GVHD).
Full Information
NCT ID
NCT04853277
First Posted
April 13, 2021
Last Updated
April 16, 2021
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04853277
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell Transplant, CAR T-Cell Transplant, CAR T-Cell Therapy, Cellular Therapy, Hematopoietic Stem Cell Transplant, HSCT, Multiple Myeloma, Leukemia, Lymphoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Education Group
Arm Type
Experimental
Arm Description
Participants will receive an educational intervention focusing on psychosocial stressors and timeline of symptoms associated with the transplant/CAR-T experience.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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 Outcome Measure Information:
Title
Change in levels of anxiety, depression, and fatigue as measured by PROMIS-29
Description
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.
Time Frame
Baseline (pre-transplant) and 1, 3, 6, and 12-months post-transplant/CAR-T
Title
Change in levels of anxiety, depression, and fatigue as measured by NCCN Distress Thermometer
Description
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).
Time Frame
Baseline (pre-transplant) and 1, 3, 6, and 12-months post-transplant/CAR-T
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
12-months post-transplant
Title
Post-Transplant Complications
Description
Post-transplant complications are defined as infections, hospitalizations, and graft versus host disease (GVHD).
Time Frame
Day 0 (date cells are infused) to 12-months post-transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Meehan, MD
Phone
603-650-5000
Email
Kenneth.R.Meehan@hitchcock.org
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Meehan, MD
Phone
603-650-5000
Email
Kenneth.R.Meehan@hitchcock.org
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
At this time there are no plans to share IPD.
Learn more about this trial
Patient Reported Outcomes and Patient Education in Cellular Therapy Patients
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