Authors
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Thome, Kevin -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2024
INTERVENTION: The study is an interventional study. NSCLC patients with a fear of cancer recurrence (FCR) will be randomly allocated to a music therapy and intervention group (Group 1, n = 31) and a control group who did not receive music therapy intervention (Group 2, n = 31). Patients’ anxiety will be measured using the State‐Trait Anxiety Inventory scores and heart rates. The primary outcome measure is assessed using PET scans. Secondary measures are salivary cortisol, salivary a‐amylase levels and heart rate. To control for selectivity bias, each participant will be randomly assigned a number using the online program RANDOM.org. All participants will then be randomly divided into Groups 1 or 2 using the online randomization program Research Randomizer. For clarity, ‘music intervention’ is defined as a patient’s exposure to music without a music therapist, and ‘music therapy intervention’ a patient’s exposure to music with a music therapist. Patients in Group 1 receive a music intervention and a music therapy intervention organized and conducted by a trained and experienced music therapist. The patients meet for two sessions, from Time ‐30 to Time 0 and from Time +30 to Time +60, for a total of 60 minutes. During the first session, before the PET examination, the subjects will be asked to restfully close their eyes and not talk in the waiting room to avoid interference with the brain’s glucose metabolism. This first session involves a passive music intervention. Music therapists developed suitable music lists for patients based on age and educational level. For the music intervention, the music therapist selects 6 songs, 3 instrumental and 3 vocal songs, with slow rhythms and comfortable melodies. If the patient felt that the music was too noisy or made them feel uncomfortable CONDITION: Reduction of fear of cancer recurrence in patients with non‐small cell lung carcinoma undergoing diagnostic PET‐CT ; Mental and Behavioural Disorders PRIMARY OUTCOME: [outcome variable] measured using a single PET‐CT scan at [time] SECONDARY OUTCOME: 1. Salivary cortisol measured using radioimmunoassay with saliva collection 30 minutes before the PET scan, shortly before the PET scan, and then at 30, 60, 70 and 80 minutes after completion of the PET scan; 2. Salivary alpha‐amylase measured using radioimmunoassay with saliva collection 30 minutes before the PET scan, shortly before the PET scan, and then at 30, 60, 70 and 80 minutes after completion of the PET scan; 3. Heart Rate measured using an ambulatory sphygmomanometer once at every saliva collection 30 minutes before the PET scan, shortly before the PET scan, and then at 30, 60, 70 and 80 minutes after completion of the PET scan; 4. State‐Trait Anxiety Inventory (STAI) measured using a questionnaire once at every saliva collection 30 minutes before the PET scan, shortly before the PET scan, and then at 30, 60, 70 and 80 minutes after completion of the PET scan INCLUSION CRITERIA: 1. Age range from 18 to 80 years old, regardless of gender 2. Patients who have been diagnosed with tumors through pathology or cytology and have received modern conventional medical treatment for tumors, including surgery, radiotherapy and chemotherapy, endocrine therapy, targeted therapy, immunotherapy, etc 3. Patient Karnofsky Functional State Scale KPS score = 80 points 4. A psychiatrist diagnosed mild to moderate anxiety and depression patients through DSM‐IV clinical diagnosis, with a score of 5‐14 on the Generalized Anxiety Scale GAD‐7 and a score of 5‐14 on the Patient Health Questionnaire Depression Screening Scale PHQ‐9 5. The patient has a certain level of emotional comprehension ability, clear language expression ability, can participate in intervention and management, has good compliance and signs an informed consent form
Epistemonikos ID: ecf30ff1d2aa1b5b6b20025a6d44fe5c42d35909
First added on: Aug 28, 2024