| Protocol ID | NCT06765707 |
| Registration Date | 2025-01-09 |
| Status | enrolling_by_invitation |
| Sponsor | Medical College of Wisconsin |
| Country | United States |
| Industry | not industry |
| Blinding | blinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2025-06-23 |
| Last Patient Out | 2029-08-01 |
| Publication | n |
| Gender % | FEMALE |
| Mean Age | 18 Years - |
NCT06765707
Symptom Monitoring Using Patient-Reported Outcomes to Optimize Medication Use
| Field |
GLM
glm-5.1 5698ms / 9340 tok |
CLAUDE
claude-sonnet-4-20250514 6191ms / 10682 tok |
OPENAI
gpt-4o 4405ms / 9185 tok |
Review |
|---|---|---|---|---|
| rct_type | cross-over RCT | cross-over RCT | cross-over RCT | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
other
shaky reasoning✓ Unanimous
Initial: other
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention involves outpatient pharmacist consultations (face-to-face or virtual visits) and monthly symptom monitoring via online surveys or phone calls, which are delivered in clinic or community settings rather than requiring hospital admission.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention involves both virtual and face-to-face visits with clinical pharmacists, making the primary setting outpatient clinical care, not requiring hospital admission or specific facility-based delivery.
|
OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is a single behavioral intervention consisting of pharmacist-delivered symptom monitoring and management, even though it has multiple components (monitoring + management), they are all part of one integrated behavioral/supportive care approach rather than combining distinct intervention types.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention consists of a single modality approach focusing on pharmacist-led symptom monitoring and management based on patient-reported outcomes, without combining distinct interventions from different categories.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention being tested is a pharmacist-delivered symptom monitoring and management program to improve medication adherence, not a screening tool itself - the patient-reported outcomes are used as part of the symptom management intervention rather than being the screening intervention being evaluated.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The primary focus is on symptom monitoring and management to optimize medication adherence, not on testing a screening tool for palliative care needs.
|
OK |
| intervention_palliative |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This is a behavioral intervention focused on symptom monitoring and pharmacist-led medication adherence support for breast cancer patients, not a palliative care consultation or service delivery intervention.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial focuses on symptom monitoring and pharmacist-led management for medication adherence, not palliative care as an intervention.
|
OK |
| intervention_education |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial primarily uses symptom monitoring with pharmacist-led management to address symptoms and barriers, rather than utilizing patient/caregiver education or training as a primary component.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is a pharmacist-led symptom monitoring and management intervention focused on improving medication adherence, not a primarily educational program.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The primary focus of the trial is symptom monitoring and management to optimize medication adherence, not education or training.
|
OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |