| Protocol ID | NCT04763174 |
| Registration Date | 2021-02-21 |
| Status | completed |
| Sponsor | Duke University |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2021-09-15 |
| Last Patient Out | 2024-12-06 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 50 Years |
NCT04763174
An mHealth Symptom Management Intervention for Colorectal Cancer Patients
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5356ms / 11263 tok |
GLM
glm-5.1 6573ms / 9834 tok |
OPENAI
gpt-4o Thinking: o3 3131ms / 9671 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 | home care | home care | home care | 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 | yes | yes | yes | OK |
| intervention_complex | yes | yes | yes | 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
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention is primarily a coping skills training program that teaches patients specific behavioral and cognitive techniques to manage their symptoms, making education/training the main therapeutic component.
Thinking: no — This is a cognitive behavioral therapy intervention delivered by a psychologist that teaches coping skills as part of psychological treatment, not primarily an educational program.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The mCOPE intervention is a cognitive behavioral coping skills training protocol designed for psychological symptom management, rather than a primary educational or training program.
|
no
no → yes → no
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — mCOPE involves structured coping skills training as a primary component to educate patients on managing symptoms, which qualifies as a primarily educational intervention.
Thinking: no — mCOPE is a cognitive-behavioral coping skills therapy (psychological intervention) rather than a standalone educational program.
|
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 | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |