| Protocol ID | NCT03592771 |
| Registration Date | 2018-07-19 |
| Status | completed |
| Sponsor | Emory University |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2018-11-15 |
| Last Patient Out | 2022-06-30 |
| Publication | y |
| Gender % | FEMALE |
| Mean Age | 18 Years - 110 Years |
NCT03592771
Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence
| Field |
GLM
glm-5.1 7013ms / 10021 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5455ms / 11398 tok |
OPENAI
gpt-4o Thinking: o3 2547ms / 9869 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel 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 | other | 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 |
yes
no
shaky reasoning✓ Unanimous
Initial: no
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention combines multiple distinct components including behavioral (app-based symptom monitoring), technological (electronic health record integration with care team alerts), and educational (tailored feedback messages with symptom-specific educational materials and coping strategies) that work together to improve adherence and symptom management.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The intervention combines behavioral components (web app usage) and educational components (tailored feedback), which interact to improve medication adherence and symptom management.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial primarily tests a web-enabled app for symptom monitoring and communication rather than focusing on patient or provider education as a primary component.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The primary intervention is a behavioral app-based communication system for symptom monitoring and adherence tracking, not an educational program, though some tailored feedback includes educational materials as a secondary component.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The primary component of the trial is a communication app to enhance adherence to endocrine therapy, focusing on improving patient-provider communication and symptom management, not primarily on education.
|
OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study explicitly evaluates costs, specifically mentioning 'resource use-related costs' in the detailed description to help achieve the 'Triple Aim' of reducing costs while improving outcomes.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study explicitly states it will evaluate costs and resource use-related costs as part of achieving the 'Triple Aim' to reduce costs while improving health outcomes.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study evaluates the impact of the intervention on resource use-related costs, fitting the criteria for cost analysis.
|
OK |
| outcome_other |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome measures medication adherence, which is not covered by the symptom/QoL/dignity/cost categories.
|
yes
yes → no → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes focus on symptom management (Endocrine Symptom Subscale, PROMIS Self-Efficacy for Managing Symptoms), quality of life measures (SF-12 Physical and Mental Component Summary scores), and medication adherence which relates to symptom management - no outcomes measure caregiver impacts, communication quality, goal-concordant care, survival, or other categories outside symptom/QoL domains.
Thinking: yes — The primary outcome is medication adherence and the study also mentions communication quality, which are not covered by symptom/QoL/dignity/cost categories.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial includes outcomes related to patient-provider communication, which are not covered by symptom, QoL, dignity, or cost categories.
Thinking: yes — Primary outcome is medication adherence, an outcome outside symptom, QoL, dignity or cost categories.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |