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

Extracted Fields (from Registry)
Protocol IDNCT06529120
Registration Date2024-07-31
Statusactive, not recruiting
SponsorDuke University
CountryUnited States
Industrynot industry
Blindingunblinded
Center Typemulticenter RCT
Scopenational RCT
First Patient In2025-09-11
Last Patient Out2026-06-30
Publicationn
Gender %FEMALE
Mean Age18 Years -
LLM Classifications (Side-by-Side)
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
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