Sleep Treatment Education Program for Cancer Survivors: Protocol for an Efficacy Trial
Notice bibliographique
Résumé
BACKGROUND: Cancer survivors are at increased risk for chronic insomnia, even years after treatment completion. As insomnia is associated with a variety of long-term health consequences, access to insomnia treatment is critically important for the survivor population. Cognitive behavioral therapy for insomnia (CBTI) is the recommended first-line treatment for insomnia but remains largely unavailable to survivors. Treatment barriers include geographic limitations, a shortage of trained providers, and demanding treatment regimens. Designed with these limitations in mind, the Sleep Treatment Education Program (STEP-1) delivers components of CBTI in a low-intensity educational intervention delivered online. OBJECTIVE: This is a phase II pilot randomized controlled trial. The primary aims are to test the efficacy of STEP-1 to improve (1) insomnia symptoms and (2) mood in cancer survivors compared to a control condition. The secondary aims will (1) explore participant factors associated with clinically significant response, (2) evaluate acceptability of the control intervention, (3) explore feasibility of delivering individualized coaching sessions for participants who do not have a significant response to STEP-1, and (4) describe participants' satisfaction with STEP-1 and suggestions for improvement. METHODS: This 2-arm randomized controlled trial enrolled 70 off-treatment cancer survivors aged 40-89 years with clinically significant insomnia. Participants are randomized to receive either the STEP-1 intervention or control condition (relaxation education); interventions are delivered in one-on-one, synchronous, virtual videoconference sessions by trained interventionists. The STEP-1 intervention presents educational information on the development of insomnia after cancer and offers suggestions for improving insomnia symptoms based on the CBTI elements of sleep hygiene, stimulus control, and cognitive restructuring. With the interventionist, participants review the suggestions and develop a personalized sleep action plan for implementation. The relaxation education session provides information on the potential benefits of relaxation and how to independently access online relaxation exercises. The Insomnia Severity Index is used to measure insomnia symptoms, and the Profile of Mood States Short Form is used to measure mood at baseline and 4 and 8 weeks after intervention. The primary end point is change in the Insomnia Severity Index score at 8 weeks, and the secondary end point is change in mood symptoms (Profile of Mood States Short Form) at 8 weeks. RESULTS: This trial was funded in July 2022. Enrollment and data collection began in February 2023 and concluded in October 2024, with 70 participants enrolled. The analysis will begin in fall 2024, and the results are expected in winter 2025. CONCLUSIONS: Trial results will determine if STEP-1 effects go beyond those that could be attributed to placebo and other nonspecific treatment factors. Should results support the efficacy of STEP-1 to improve mood and insomnia symptoms, we anticipate developing efficacy and implementation trials of STEP-1 in larger and more diverse samples. TRIAL REGISTRATION: ClinicalTrials.gov NCT05519982; https://clinicaltrials.gov/study/NCT05519982. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60762.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,029 | 0,027 |
| Méta-épidémiologie (sens strict) | 0,006 | 0,003 |
| Méta-épidémiologie (sens large) | 0,009 | 0,005 |
| Bibliométrie | 0,002 | 0,004 |
| Études des sciences et des technologies | 0,005 | 0,003 |
| Communication savante | 0,004 | 0,003 |
| Science ouverte | 0,003 | 0,002 |
| Intégrité de la recherche | 0,006 | 0,010 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,129 | 0,019 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».