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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education Group | Experimental | Participants will receive an educational intervention focusing on psychosocial stressors and timeline of symptoms associated with the transplant/CAR-T experience. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 12-months post-transplant | |
| 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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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
At this time there are no plans to share IPD.
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|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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