Clinical trial · Interventional
Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice
- 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 study purpose is to compare usual hospice care and PAINRelieveIt groups for effects on: (1) patient outcomes (analgesic adherence; worst pain intensity, satisfaction, and misconceptions) and lay caregiver outcome (pain misconceptions) in a diverse sample of 250 cancer patient-caregiver dyads receiving hospice care; and (2) nurse outcomes (obtained appropriate analgesics for patient) in a sample of hospice nurses. The investigators hypothesize that at posttest, controlling for pretest data and compared to the usual care group, the PAINRelieveIt group will: a) report decreased scores for worst pain intensity and pain misconceptions; b) have increased analgesic adherence (primary outcome); and c) have a larger proportion who report satisfaction with pain intensity and whose nurses obtained appropriate analgesics for the patients' pain.
Conditions
Conditions (2)
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 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PAINConsultN | Behavioral | — | UNRESOLVED |
| PAINReportIt | Behavioral | — | UNRESOLVED |
| PAINUCope | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- usual hospice care
- description
- The usual care group will receive the typical hospice care and interact with PAINReportIt to provide data necessary for the analysis of study aims. They will use the tablet computer at baseline and at the study end and daily between. They also will have access to what looks like PAINUCope, but is really computer games so that they have similar attention with the computer as the experimental group. For ethical purposes, we will provide a PAINReportIt Summary to their hospice nurses to have access to their pain assessment information, something we did not do in previous studies focused on efficacy of the interventions.
- interventionNames
- Behavioral: PAINReportIt
- type
- EXPERIMENTAL
- label
- PAINRelieveIt (experimental group)
- description
- We will use Nursing Consult LLC's PAINRelieveIt software that includes: (1) PAINReportIt that has screens to collect pain, medications, and misconception data; (2) the intervention for the nurse clinicians, PAINConsultN; and (3) the intervention for the patients and lay caregiver, PAINUCope. This innovative, new program is the first computerized, multi-dimensional, self-report measure of pain with clinician decision support for analgesic prescriptions and multimedia patient education tailored to the patient's misconceptions and pain. Prototype versions of PAINConsultN and PAINUCope were tested in recently completed studies among outpatients with cancer and patients with sickle cell disease in outpatient, emergency and hospital settings.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Study inclusion criteria require that the patient: (1) be admitted to home care level of hospice service; (2) has a diagnosis of cancer; (3) has experienced worst pain in the past 24 hours \>3 on a 0-10 scale; (4) speaks, reads and writes English, Spanish, or Chinese; (5) is \> 18 years of age; 6) has a lay caregiver who is \> 18 years of age and willing to participate; and (7) has a life expectancy of about 19 days at the time of study enrollment, as suggested by a Palliative Performance Scale (PPS)41 score of \> 40. The lay caregiver inclusion criteria require that the individual: (1) be designated as the primary lay caregiver for the participating patient during the 7-day study period; (2) speaks, reads and writes English, Spanish, or Chinese; and (3) is \> 18 years of age. The hospice nurse inclusion criteria require that the individual: (1) be assigned as the primary hospice nurse for the participating patient during the 7-day study period; (2) speaks, reads and writes English (since the PAINConsultN is in English) but may speak Spanish or Chinese for clinical care purposes; and (3) is \> 18 years of age. Exclusion Criteria: * Patients and lay caregivers will be excluded if they: (1) are legally blind or deaf; or (2) have cognitive or physical impairments making it impossible to communicate or to complete study instruments at enrollment or any time during the study.
References
Publications (0)
Data not yet available