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The goal of this study is to evaluate the change in symptoms for women with cancer-related malignant ascites who complete an at-home paracentesis procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| At-home Paracentesis | Experimental | Participants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| At-home Paracentesis | Procedure | Paracentesis is a bedside procedure to obtain ascitic fluid from the peritoneum through needle aspiration, performed for both diagnostic and therapeutic purposes. The procedure involves needle insertion into the peritoneal cavity to remove fluid for analysis or to relieve symptoms from tense ascites. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis. | To evaluate the change in symptoms in patients who complete at-home paracentesis. The AIM survey consists of 3 questions from 0 (No Symptoms) to 5 (Very Severe). A lower score is better. At the end of the study, all the results will be added together for the TSS. A lower score is preferred to show a positive outcome. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type. | To assess the safety and tolerability of at-home paracentesis. | 3 months |
| The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0). |
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Inclusion Criteria:
Exclusion Criteria:
Female aged ≥ 18 years
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan Sharry | Contact | 801-585-3453 | susan.sharry@hci.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anna Beck, MD | Huntsman Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute at the University of Utah | Salt Lake City | Utah | 84112 | United States |
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|
To assess the safety and tolerability of at-home paracentesis. |
| 3 months |
| The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness. | To assess the safety and tolerability of at-home paracentesis. | 3 months |
| The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration. | To assess the safety and tolerability of at-home paracentesis. | 3 months |
| The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to the study intervention. | To assess the safety and tolerability of at-home paracentesis. | 3 months |
| The rate of procedure-related complications, including pain, bleeding, infection, and volume depletion. | To assess the rate of procedure-related complications after at-home paracentesis. | 3 months |