| Protocol ID | NCT06529120 |
| Registration Date | 2024-07-31 |
| Status | active, not recruiting |
| Sponsor | Duke University |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2025-09-11 |
| Last Patient Out | 2026-06-30 |
| Publication | n |
| Gender % | FEMALE |
| Mean Age | 18 Years - |
NCT06529120
Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5139ms / 11062 tok |
GLM
glm-5.1 11082ms / 9668 tok |
OPENAI
gpt-4o Thinking: o3 2834ms / 9521 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | 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
shaky reasoning✓ Unanimous
Initial: home care
Requery: home care — The intervention sessions are conducted remotely via conference (Zoom) or telephone, meaning participants receive the treatment from their own homes.
|
home care
home care → home care
shaky reasoning✓ Unanimous
Initial: home care
Requery: home care — The intervention sessions are conducted remotely via Zoom or telephone, which means patients receive the intervention in their own homes.
|
home care
other → home care
shaky reasoning✓ Unanimous
Initial: other
Requery: home care — The intervention sessions are delivered remotely via conference (Zoom) or telephone to participants in their own homes.
|
OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary |
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention includes mindfulness-based strategies, which is a complementary and alternative medicine modality.
Thinking: no — This is a mindfulness-based therapy combined with cognitive-behavioral strategies, which falls under psychological interventions rather than complementary medicine.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is based on mindfulness and cognitive-behavioral strategies, which are psychological rather than complementary modalities.
|
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention involves mindfulness and cognitive-behavioral strategies, which are psychological therapies, not complementary modalities like acupuncture or herbal remedies.
Thinking: no — The intervention is a psychological mindfulness-based cognitive-behavioral therapy, not an alternative modality such as acupuncture, yoga, or herbal remedies.
|
OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | yes | yes | yes | OK |
| intervention_complex |
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The Nite2Day intervention explicitly combines mindfulness-based strategies with cognitive-behavioral techniques, representing two distinct therapeutic modalities working together for insomnia and symptom management.
Thinking: no — This is a single behavioral/psychological intervention combining mindfulness and cognitive-behavioral techniques, both from the same intervention category.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention combines mindfulness and cognitive-behavioral strategies into a single unified behavioral/psychological therapy for insomnia and symptom management.
|
no
no → yes → no
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The intervention combines mindfulness-based therapy with cognitive-behavioral symptom management techniques, representing psychological and behavioral components from different categories that interact to manage symptoms in breast cancer patients.
Thinking: no — Mindfulness training and CBT coping skills are both behavioral/psychological elements within a single modality, not multiple distinct categories.
|
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 | 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 |