RESUMO
AIMS: This study will assess the efficacy of digital CBT for insomnia (dCBT-I) compared to sleep hygiene education (SHE) for the management of insomnia in women with cancer. BACKGROUND: 30% of patients with cancer meet insomnia diagnostic criteria and this can be detrimental to health outcomes. Insomnia disorder comprises a dissatisfaction with sleep quantity or quality characterized by difficulty initiating sleep, frequent awakenings, or early morning wakening without the ability to return to sleep, at least 3 nights per week, for at least 3 months, causing significant impairment or distress in areas of functioning. METHODS: We will recruit 308 women with a current or prior cancer diagnosis who are currently experiencing insomnia; defined as a score of 16 or less on the Sleep Condition Indicator (SCI). Participants will be randomised to dCBT-I or SHE. dCBT-I will be delivered online via 6 sessions. SHE will be provided in an online format. Assessments of sleep and other related parameters, through validated questionnaires, will be taken at 12 and 24 weeks following intervention. Once 24 week assessments are completed, participants will crossover to the alternate arm (either SHE or dCBT-I) and undergo a final assessment at week 36. OUTCOMES: The primary outcome will be the mean continuous change in SCI score in the intervention arm compared to the control arm at 24 weeks. Additionally, the proportion of women with an SCI > 16 at 24 weeks will be assessed. Secondary outcomes include fatigue, sleep related quality of life, depression, anxiety, and hot flush interference. REGISTRATION: This study is registered on ClinicalTrials.gov with number NCT05816460.
Assuntos
Terapia Cognitivo-Comportamental , Neoplasias , Distúrbios do Início e da Manutenção do Sono , Humanos , Feminino , Distúrbios do Início e da Manutenção do Sono/etiologia , Distúrbios do Início e da Manutenção do Sono/terapia , Qualidade de Vida , Sono , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: Multidetector computed tomography (MDCT) is routinely used in the surveillance of epithelial ovarian cancer. The aim of this study was to determine the incidence of thoracic findings on routine MDCT surveillance imaging in patients with ovarian carcinoma. MATERIALS AND METHODS: Retrospective evaluation of 100 MDCT studies of patients with a diagnosis of epithelial ovarian cancer was performed at a university teaching hospital. The cross-sectional studies were reviewed by a consultant radiologist with subspeciality training in cross-sectional imaging. RESULTS: Intrathoracic findings were identified in 35% of patients. Pleural effusions were identified in 40%, pulmonary nodules in 37%, mediastinal adenopathy in 17%, and thyroid nodules in 6% of patients. Thirty-five (35%) patients were found to have thoracic findings on computed tomography. Pleural effusions developed in 14 (40%) of these patients. Small lung nodules (<1 cm) were present in 13 (37%) patients. Mediastinal lymphadenopathy was seen in 6 (17%) patients. Two patients (6%) had thyroid nodules of unknown significance. Pleural effusions and small lung nodules were present at a similar level to that of the general population. CONCLUSIONS: This retrospective study supports the imaging recommendations of the European Society of Urogenital Radiology that MDCT protocols for the initial staging and evaluation of recurrent disease in epithelial ovarian carcinoma require only inclusion of the lung bases to the inguinal region reducing exposure to ionizing radiation, alleviating patient anxiety, and offering a cost-benefit to hospitals.