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Approximately 66% of patients with advanced cancer experience pain, which is often inadequately controlled and associated with a decline in health-related quality of life (HRQoL). Conventional pharmacologic management, ranging from simple analgesics to strong opioids, is frequently limited by insufficient efficacy and systemic side effects. Intrathecal drug delivery (IDD) offers targeted, continuous medication infusion directly into the intrathecal space, allowing lower systemic doses and potentially reducing side effects while maintaining effective analgesia. The CAREGIVER study is a randomized, controlled trial designed to evaluate whether patients with severe refractory cancer pain receiving IDD experience a difference in HRQoL compared to those receiving conventional medical management (CMM) with oral pain medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal Drug Delivery | Active Comparator |
| |
| Comprehensive Medical Management | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal Drug Delivery | Procedure | Patients assigned to the IDD-group (intervention group) will undergo implantation of an IDD pump (Synchromed™, Medtronic). The device will be placed subcutaneously in the abdominal region and connected to a catheter delivering pain medication directly into the intrathecal space surrounding the spinal cord. At the time of implantation, the pump will be filled with medication, such as morphine, local anesthetics, or a combination thereof, and an initial daily dose will be selected. In the days following surgery, dose titration will be performed to establish the optimal balance between pain relief and tolerability. Following implantation, the most common postoperative procedure is the drug refill. This involves aseptic access to the pump reservoir, removal of any residual volume, and replenishment with a fresh dose of medication. Refill intervals will depend on the patient's daily dosage, ranging from monthly to once every 2-3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | Health-related quality of life will be evaluated with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). | At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient comfort | Patient comfort is evaluated with the General Comfort Questionnaire (GCQ), a self-reported instrument consisting of 48 items that reflect the physical, spiritual, environmental, and social dimension. | At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation |
| Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maarten Moens, MD PhD MBA | Contact | +3224775514 | stimulusresearchgroup@gmail.com | |
| Lisa Goudman, MSC, PhD | Contact | +32472412507 | lisa.goudman@vub.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Recruiting | Jette | 1090 | Belgium |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Comprehensive Medical Management | Drug | Participants randomized to the CMM-group will receive standard care. |
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The survival rate will be determined by recording the time from treatment initiation until death. |
| At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation |
| Pain intensity | Pain intensity will be measured with the Visual Analogue Scale (ranging from 0 (no pain) to 100 (maximal pain)) in electronic format. Momentary data collection will be used to collect pain intensity scores for VAS (valid and reliable for pain experience), whereby pain intensity is measured for multiple times per day for 1 week to reveal patterns of transient or fluctuating symptoms in the environment and context of the patients' lives, without a recall bias. | At baseline and 1, 2, 4, 6, 8, 10, and 12 months post-treatment initiation |
| Perceived stress | Perceived stress will be assessed by using the 10-item Perceived Stress Scale. | At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation |
| Anxiety | Patient anxiety will be provided through the State Trait Anxiety Inventory (STAI). | At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation |
| Perceived Injustice | Using the Injustice Experience Questionnaire (IEQ), perceived injustice related to current health status will be assessed. | At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation |
| Self-efficacy | The General Self-Efficacy (GSE) Scale is a 10-item self-report questionnaire used to assess perceived self-efficacy. | At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation |
| Caregiver burden | To evaluate caregiver burden, the Zarit Burden Interview (ZBI) questionnaire will be completed. This 12-item self-report instrument assesses caregiver burden and is a shortened version of the original 22-item Zarit Burden Scale. | At baseline and 1, 2, 4, 6, and 12 months post-treatment initiation |
| Health expenditure | Expenditures related to in-hospital care will be extracted from hospital claims data. All other healthcare-related costs will be gathered through telephone interviews with patients, conducted each month after treatment initiation. During these calls, researchers will ask patients whether they have had any medical consultations, hospital admissions, AEs, changes in medication (such as daily morphine, MED, antidepressants,…), or incurred any additional healthcare costs. | monthly after treatment initiation until 12 months |
| Safety | Recording of (serious) adverse events. | Throughout the duration of the study, an average of 12 months. |
| Number of responders | Responder status will be determined based on pain scores, adverse events, and medication dose changes. Responders are defined as patients achieving a clinically meaningful reduction in pain intensity (≥30% from baseline) without intolerable adverse effects. | at 1, 2, 4, 6, and 12 months post-treatment initiation |