NCT03592771

Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence

Extracted Fields (from Registry)
Protocol IDNCT03592771
Registration Date2018-07-19
Statuscompleted
SponsorEmory University
CountryUnited States
Industrynot industry
Blindingunblinded
Center Typemulticenter RCT
Scopenational RCT
First Patient In2018-11-15
Last Patient Out2022-06-30
Publicationy
Gender %FEMALE
Mean Age18 Years - 110 Years
LLM Classifications (Side-by-Side)
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
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