Clinical trial NCT05881889: Effects of Repetitive Transcranial Magnetic Stimulation on Fear of Cancer Recurrence: mPFC-amygdala-hippocampus
Official title: Effects of Repetitive Transcranial Magnetic Stimulation on Fear of Cancer Recurrence: mPFC-amygdala-hippocampus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychology
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study will be a parallel assignment randomised controlled trial (RCT). Patients will be randomly assigned to rTMS intervention group (rTMS+ TAU), sham stimulation group (sham+ TAU). Treatment will be performed 5 times a week for 4 weeks. 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 screening, assessments, allocation and intervention will all be carried out via a WeChat mini Program (a widely used social communication application, with more than 1.2 billion users in China) specially tailored for the trial. An information sheet will be provided online, and informed consent will be completed online before participation in the study.

Eligibility criteria: 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.

Primary outcomes:
measure: Fear of Cancer Recurrence Questionnaire (FCRQ7)
timeFrame: we use FCRQ7 to assess the change of FCR level from baseline to 4, 5, 8, 16 weeks follow up
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ9)
timeFrame: we use PHQ9 to assess the change of depression level from baseline to 4, 5, 8, 16 weeks follow up
measure: Generalized Anxiety Disorder (GAD7)
timeFrame: we use GAD7 to assess the change of anxiety level from baseline to 4, 5, 8, 16 weeks follow up
measure: Numeric Rating Scale (NRS)
timeFrame: we use NRS to assess the change of pain level from baseline to 4, 5, 8, 16 weeks follow up
measure: Insomnia Severity Index (ISI)
timeFrame: we use ISI to assess the change of insomnia severity from baseline to 4, 5, 8, 16 weeks follow up
Other outcomes:
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