Clinical trial · Interventional
Shared Decision Making in Pain Management Planning in Patients With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this project is to evaluate the effectiveness of shared-decision-making (SDM) to manage chronic and breakthrough pain in patients with cancer. Providers will receive evidence-based education on shared decision-making strategies and comprehensive pain management at study start up. In addition, the information will be available on the Carevive platform for reference at the point of care. This multisite study will enroll 105 patients from three cancer institutions. This project will explore the SDM model using a touchscreen-based expanded pain assessment (EPA) to evaluate the impact of the shared-decision-making model on pain management, and explore its relationship to pain management care planning. Patients will use the Carevive Systems software in the clinic to answer questions regarding decision making preferences and complete a comprehensive assessment of their pain status. Treatment recommendations and a care plan will be provided to the patient at the time of the visit. At each clinic visit over 4 months, the patient will again complete the pain assessment and receive appropriate treatment recommendations and a revised care plan.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The Carevive CPS | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Effect of pain care plan on pain outcomes
- timeFrame
- Year 1
- description
- Pain intensity over time will be measured by the Sum of Pain Intensity Differences (SPID).
Secondary outcomes (2)
- measure
- Contribution of shared-decision-making on pain outcomes will be evaluated using the PainCQ© surveys
- timeFrame
- Year 1
- description
- The PainCQ measures the patient's perception of the quality of pain management by the interdisciplinary team and whether the patient felt included in decision making.
- measure
- Feasibility of the proposed shared decision-making model to effectively manage chronic pain experienced by patients with cancer
- timeFrame
- Year 1
- description
- Participating OCM practices will complete a single feasibility assessment measuring completeness of each intervention tool
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All participants must be 18 years of age or older. * Patient participants must have a diagnosis of cancer * Patients must have screened positive for pain per a previous clinical assessment * All participants must be able to understand English. Exclusion Criteria: * Any patient who cannot understand written or spoken English. * Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
References
Publications (0)
Data not yet available