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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01344 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0321 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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Study halted prematurely, prior to enrollment of first participant
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well rectal administration of opioids using the Macy catheter works in reducing pain in patients with cancer that has spread to other anatomic sites or is no longer responding to treatment. Rectal administration of opioids using the Macy catheter may help to reduce the cost of care, resolve the issue of medication availability currently faced in the form of parenteral opioid shortage throughout the country, and provide adequate comfort and symptom relief for patients with smoother transition out of hospital.
PRIMARY OBJECTIVES:
I. Determine the feasibility of using the device 'Macy catheter' for rectal administration of opioids for comfort in cancer patients on palliative care.
SECONDARY OBJECTIVES:
I. To determine the ease of use, level of satisfaction and overall perception of effectiveness of 'Macy catheter' for rectal administration of opioids for pain control in advanced cancer patients, by the hospital bedside nursing staff.
II. To assess patients' (or primary care-giver's) experience of using the 'Macy catheter' 48 hours after discharge from the hospital.
III. To assess the hospice staff (or primary care-giver's) experience of using the 'Macy catheter' after patient's death.
OUTLINE:
Patients undergo placement of rectal catheter and receive opioids through the Macy catheter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device feasibility (Macy catheter, opioids) | Experimental | Patients undergo placement of rectal catheter and receive opioids through the Macy catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macy Catheter | Device | Undergo placement of Macy catheter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of using the device 'Macy catheter' for rectal administration of opioids for comfort in cancer patients on palliative care as defined by number of doses administered and patient satisfaction | Will be assessed by the number of doses that a patient finishes (at least 4 out of 6 doses administered) and by asking patients' about their level of satisfaction and overall perception of effectiveness of using the device, collected by question 10 and 11 in the survey, respectively. The association between patients' demographics and clinical characteristics and patients' satisfaction and perception of effectiveness will be evaluated by Wilcoxon rank sum test and chi-square (or Fisher's exact) test for continuous and categorical variables, respectively. In order to address the primary objective, the feasibility rate will be estimated and reported along with a 95% Clopper-Pearson exact confidence interval. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Episodes of confusion (delirium) assessed by primary caregiver survey | Up to 1 year | |
| Hospice nurse experience assessed by survey | Will be summarized by frequency tables. McNemar's test will be applied to evaluate whether the feasibility changes from the time at the hospital to 48 hours of discharge. Other statistical methods may be applied when appropriate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahsan Azhar | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Pain Therapy |
| Procedure |
Receive opioids via Macy catheter |
|
|
| Questionnaire Administration | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| Up to 1 year |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000698 | Analgesia |
| D059408 | Pain Management |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D013812 | Therapeutics |
| D019468 | Disease Management |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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