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Expressive Helping, Factual Writing · 1 trial · 2 indications
MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0="not present" to 10="As bad as you can imagine") to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.
| Arm | Type | Description |
|---|---|---|
| Expressive Helping writing | EXPERIMENTAL | Writing sessions 1-3: Participants complete one 20-minute expressive writing session at three time points: 1) after hospitalization but prior to transplant infusion, (2) approximately 3 days after hospital discharge, and (3) approximately 2 weeks after completion of writing session 2. Writing session 4: One 20-40 minute peer support writing session about 1 week after completion of writing session 3. |
| Factual Writing | ACTIVE_COMPARATOR | Writing sessions 1-3: Participants complete one 20-minute factual session at three time points: 1) after hospitalization but prior to transplant infusion, (2) approximately 3 days after hospital discharge, and (3) approximately 2 weeks after completion of writing session 2. Writing session 4: One 20-40 minute factual writing session about 1 week after completion of writing session 3. |
| Name | Type | Description |
|---|---|---|
| Expressive Helping | BEHAVIORAL | Expressive Helping (EH) is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience using previously-tested EH instructions, adapted for this population. |
| Factual Writing | BEHAVIORAL | Factual Writing has been used with cancer patients and in the investigators' prior EH trial. It is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience using standard Factual Writing instructions. |
Inclusion Criteria: * Cancer patients * Age ≥ 18 * English proficient * Scheduled for allogeneic or autologous transplant at JTCC, LCCC, or RHLCC. Exclusion Criteria: * Current participation in a behavioral intervention targeting symptoms or quality of life * Cognitive or psychiatric impairment p...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| TransMedics Group, Inc. | TMDX | 4 | - | Undisclosed |
| CareDx, Inc. | CDNA | 1 | N/A | Undisclosed |
Expressive Helping is an investigational behavioral intervention studied for use in stem cell transplantation, specifically in patients with hematologic malignancy. It was evaluated in a Phase 3 clinical trial in the United States. The drug is not approved and remains in clinical development.
Expressive Helping is developed by Meridian Bioscience Inc, traded on the stock exchange under the ticker VIVO. The company conducted a Phase 3 clinical trial of the intervention in stem cell transplant patients with hematologic malignancy.
Expressive Helping is in Phase 3 clinical development. A Phase 3 trial with 405 participants has been completed. The drug is investigational and has not been approved by regulatory authorities.
Expressive Helping has one completed Phase 3 clinical trial, identified as NCT03800758, titled 'Expressive Helping for Stem Cell Transplant Patients.' The trial enrolled 405 participants with stem cell transplantation and hematologic malignancy in the United States.
Expressive Helping is not FDA approved. It is an investigational intervention that has completed a Phase 3 clinical trial. The trial was active-controlled and randomized, but approval status has not been established.