Patient Reported Outcomes and Patient Education in Cellular Therapy Patients

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853277
• Other study ID #: STUDY02000641
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplant
• HSCT
• Leukemia
• Lymphoma
• Multiple Myeloma
• Stem Cell Transplant

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