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The goal of this study is to ask chronic pain patients their preferences regarding which side effects of pain medications are least acceptable in relation to their pain relief benefits. This information may help in the selection of improved treatment options in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic pain patients | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient questionnaire | Other | Online patient questionnaire that assesses multiple aspects such as current analgesic use, side effect burden, treatment satisfaction and patient preferences. |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic pain patient preferences of pain medications regarding pain relief relative to the side effects using numeric rating scales (adaptation of the outcome prioritization tool). | Using numeric rating scales from 0 to 10 (adaptation of the outcome prioritization tool) to assess patient perceived importance of analgesic effect relative to not having the following side effects: fatigue, drowsiness (sleepiness), dizziness, difficulty concentrating, nausea, constipation (difficulty passing stools), dry mouth, unintentional weight gain, addiction (medication craving). Higher scores mean the specific outcome is a higher priority for the participant. | Single measure at a time selected by the participant within the study period (up to 15 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic side effect burden measured by numeric rating scales (NRS) | Using numeric rating scales, from 0 to 10, to assess current burden of the following analgesic side effects: fatigue, drowsiness (sleepiness), dizziness, difficulty concentrating, nausea, constipation (difficulty passing stools), dry mouth, unintentional weight gain, addiction (medication craving). Higher scores mean being more affected by the side effects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLouvain/IONS | Recruiting | Brussels | 1200 | Belgium |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000073222 | Patient Health Questionnaire |
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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| Single measure at a time selected by the participant within the study period (up to 15 months). |
| Patient pain levels in the last 24 hours and pain body location and its impact on functioning measured by the Brief Pain Inventory short form (BPI-SF). | Single measure at a time selected by the participant within the study period (up to 15 months). |
| Overall pain levels in the past 7 days measured by a numeric rating scale. | Numeric rating scale from 0 to 10, with higher scores meaning higher pain levels. | Single measure at a time selected by the participant within the study period (up to 15 months). |
| Overall sleep quality in the past 7 days measured by a numeric rating scale. | Numeric rating scale from 0 to 10, with higher scores meaning better sleep. | Single measure at a time selected by the participant within the study period (up to 15 months). |
| Satisfaction of pain treatment will be assessed by select items from the PTSS | Patient treatment satisfaction will be assessed using 6 selected items from the Pain Treatment Satisfaction Scale (PTSS). The 6 items using 5-point Likert scales assess satisfaction of the time that it takes their pain medication to work, level or amount of pain relief, duration of pain relief, overall satisfaction, and to what extend the level of pain relief meet their expectations. | Single measure at a time selected by the participant within the study period (up to 15 months). |
| Evaluating Patient characteristics | Patient characteristics including demographics and which pain type/diagnosis and medications and dose are used including alternative/supplementary treatments. | Single measure at a time selected by the participant within the study period (up to 15 months). |
| MacArthur Scale of Subjective Social Status assessing subjective social status | Single-item measure, on a scale from 1 to 10, that assesses a person's perceived rank relative to others with a higher score meaning a higher rank. | Single measure at a time selected by the participant within the study period (up to 15 months). |
| Single Item Global Quality of Life Scale (SIG-QoL) | Assessing global quality of life through a Numerical Rating Scale on a scale from 0 to 100 that includes 11 descriptive markers where a higher scores means a better QOL. | Single measure at a time selected by the participant within the study period (up to 15 months). |
| Patient Health Questionnaire-4 (PHQ-4) is used to measure anxiety and depression | The PHQ-4 uses a 4-point Likert scale (Not at all, Several days, More than half the days, Nearly every day). | Single measure at a time selected by the participant within the study period (up to 15 months). |
| Current Opioid Misuse Measure - 9 items (COMM-9) is used to identify current aberrant opioid-related behavior in chronic pain patients on long-term opioid therapy | The COMM-9 uses a 5-point Likert scale (Never, Seldom, Sometimes, Often, Very often). | Single measure at a time selected by the participant within the study period (up to 15 months). |
| PROMIS Item Bank v2.0 - Cognitive Function- Short Form 4a assesses patient-perceived cognitive deficits. | The PROMIS Item Bank v2.0 - Cognitive Function- Short Form 4a uses a 5-point Likert scale (Never, Rarely (Once), Sometimes (Two or three times), Often (About once a day), Very often (Several times a day)). | Single measure at a time selected by the participant within the study period (up to 15 months). |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |