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Trial Title:
Effects of Repetitive Transcranial Magnetic Stimulation on Fear of Cancer Recurrence: mPFC-amygdala-hippocampus
NCT ID:
NCT05881889
Condition:
Psychology
Conditions: Official terms:
Recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
low-frequency repetitive transcranial magnetic stimulation
Description:
For patients in the rTMS group, we will first determine the intensity of the rTMS
protocol by assessing the individual resting motor threshold (rMT). After determination
of each individual's rMT, we will set rTMS intensity at 100% of the rMT and apply a
single train of low-frequency rTMS over the DLPFS at 1 Hz for a total duration of 30 min
(2000 pulses).
Arm group label:
repetitive transcranial magnetic stimulation
Intervention type:
Device
Intervention name:
sham low-frequency repetitive transcranial magnetic stimulation
Description:
sham low-frequency repetitive transcranial magnetic stimulation
Arm group label:
sham stimulation
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 1, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05881889
