Psychology Clinical Trial
Official title:
Effects of Repetitive Transcranial Magnetic Stimulation on Fear of Cancer Recurrence: mPFC-amygdala-hippocampus
Introduction: Previous studies have shown that many breast cancer patients are suffering from fear of cancer recurrence (FCR). However, effective physical intervention for FCR has been scarce. In this study, low-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the right dorsolateral prefrontal cortex (DLPFC) will be applied on patients with high FCR. We aim to assess the efficacy of low-frequency rTMS in the treatment of FCR in breast cancer patients. Methods and analysis: This will be a two-arm, randomised controlled trial comparing rTMS, sham stimulation in breast cancer patients with high FCR. A total of 50 breast cancer patients with a high FCR score (>27) will be recruited. Patients will be randomly assigned to receive 4-week rTMS, sham stimulation. Assessments will be conducted at week 0 (baseline), week 4 (the end of intervention), week 5 (1 week post-treatment), week 8 (1 month post-treatment), and week 16 (3 months post-treatment). The primary outcome of the study will be to ascertain, whether the rTMS program is sufficient in relieving FCR in breast cancer patients (measured by the 7-item FCR scale). Additionally, GAD7, PHQ9, NRS, and ISI7 will be used to measure individual's anxiety, depression, pain, and insomnia symptoms.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Adult; 2. Breast cancer patients undergoing treatment for the first time; 3. Able to understand and sign informed consent; 4. Being able to comply with the intervention. Exclusion Criteria: 1. Minors; 2. Having a diagnosis for a significant untreated mental or medical illness (e.g., consciousness disturbances, mania, acute phase of schizophrenia, major depressive disorder, etc.); 3. Patients with recurrent cancer; 4. Hospice patients. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Guangdong Provincial People's Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fear of Cancer Recurrence Questionnaire (FCRQ7) | There are 7 items scored on 5 levels, the total score of each item is summed up. The score above 27 indicates that the patient has significant fear, which requires certain psychological intervention and treatment. | we use FCRQ7 to assess the change of FCR level from baseline to 4, 5, 8, 16 weeks follow up | |
Secondary | Patient Health Questionnaire (PHQ9) | The PHQ9 strictly conforms to the 9 symptomatic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5), with each item scoring 0-3 points and the total value range 0-27 points. PHQ9 can be used for both screening and evaluating the severity of depression. The results of PHQ9 are graded as follows: 0-4: no depression; 5-9: mild depression; 10-14: moderate depression; 15-19: moderate to severe depression; and 20-27: severe depression | we use PHQ9 to assess the change of depression level from baseline to 4, 5, 8, 16 weeks follow up | |
Secondary | Generalized Anxiety Disorder (GAD7) | The total score is categorized as follows: 0-4: no generalized anxiety; 5-9: mild generalized anxiety; 10-14: moderate generalized anxiety; and 15-21: severe generalized anxiety. | we use GAD7 to assess the change of anxiety level from baseline to 4, 5, 8, 16 weeks follow up | |
Secondary | Numeric Rating Scale (NRS) | Participant's somatic pain level will be assessed using the "0-10" numeric rating scale (NRS) (i.e., how would you rate your pain at its worst over the past 3 days?) , in which 0 means 'no pain' and 10 means 'the worst pain'. Participants will be asked to select a number between 0 and 10, to indicate their current pain level. A total score of 4 or more indicates that the patient is currently suffering from pain. | we use NRS to assess the change of pain level from baseline to 4, 5, 8, 16 weeks follow up | |
Secondary | Insomnia Severity Index (ISI) | The change in insomnia symptoms will be measured by the insomnia severity index (ISI) , which assesses the severity, nature, and impact of insomnia. It is a 7-item self-report measure, ranging from 0 (no problem) to 4 (very severe problem). The resulting sum score of the ISI ranges from 0 to 28. Higher scores indicate more severe insomnia symptoms. | we use ISI to assess the change of insomnia severity from baseline to 4, 5, 8, 16 weeks follow up |
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