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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04853277
Other study ID # STUDY02000641
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 7, 2021
Est. completion date March 29, 2023

Study information

Verified date November 2023
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date March 29, 2023
Est. primary completion date March 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (1)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Overall Survival 12-months post-transplant
Secondary Post-Transplant Complications Post-transplant complications are defined as infections, hospitalizations, and graft versus host disease (GVHD). Day 0 (date cells are infused) to 12-months post-transplant
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