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PsychologyNCT05881889

Effects of Repetitive Transcranial Magnetic Stimulation on Fear of Cancer Recurrence: mPFC-amygdala-hippocampus

A study testing low-frequency repetitive transcranial magnetic stimulation in people with Psychology, run by Guangdong Provincial People's Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Psychology
What is being tested?
low-frequency repetitive transcranial magnetic stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
No sites listed yet
Study dates
1 Jul 2023to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult;
  • Breast cancer patients undergoing treatment for the first time;
  • Able to understand and sign informed consent;
  • Being able to comply with the intervention.

Who cannot join

  • Minors;
  • Having a diagnosis for a significant untreated mental or medical illness (e.g., consciousness disturbances, mania, acute phase of schizophrenia, major depressive disorder, etc.);
  • Patients with recurrent cancer;
  • Hospice patients.

Trial locations and contacts

No sites are listed yet.

Yuan Yang, Doctor contact

18825059293

yangyuan@gdph.org.cn

About this study

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.

Read the 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.

Conditions
Psychology
Being tested
low-frequency repetitive transcranial magnetic stimulation, sham low-frequency repetitive transcranial magnetic stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low-frequency repetitive transcranial magnetic stimulationDevice

    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).

  • sham low-frequency repetitive transcranial magnetic stimulationDevice

    sham low-frequency repetitive transcranial magnetic stimulation

Study groups in NCT05881889
Study groupRoleWhat they receive
repetitive transcranial magnetic stimulationExperimentalFor 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). receive 4 week rTMS treatment.
Receives: Device: low-frequency repetitive transcranial magnetic stimulation
sham stimulationSham comparatorFor patients in the sham group, we will apply rTMS over the DLPFS in sham modality.
Receives: Device: sham low-frequency repetitive transcranial magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: we use FCRQ7 to assess the change of FCR level from baseline to 4, 5, 8, 16 weeks follow up

Secondary outcomes (4)

  1. 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

    Measured: we use PHQ9 to assess the change of depression level from baseline to 4, 5, 8, 16 weeks follow up

  2. 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.

    Measured: we use GAD7 to assess the change of anxiety level from baseline to 4, 5, 8, 16 weeks follow up

  3. 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.

    Measured: we use NRS to assess the change of pain level from baseline to 4, 5, 8, 16 weeks follow up

  4. 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.

    Measured: we use ISI to assess the change of insomnia severity from baseline to 4, 5, 8, 16 weeks follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2023
  2. Study start1 Jul 2023 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05881889
Sponsor's protocol ID
8220053738
Status last verified
Feb 2023
First submitted
20 Mar 2023
Last updated
31 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu W, Zhao N, Li W, Qiu L, Luo X, Lin Y, Wang W, Garg S, Sun H, Yang Y. Effects of repetitive transcranial magnetic stimulation on fear of cancer recurrence and its underlying neuromechanism. Contemp Clin Trials Commun. 2024 Apr 23;39:101299. doi: 10.1016/j.conctc.2024.101299. eCollection 2024 Jun.

    PubMed 38720913

Questions about this trial

What is this clinical trial studying?

A study testing low-frequency repetitive transcranial magnetic stimulation in people with Psychology, run by Guangdong Provincial People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yuan Yang, Doctor (18825059293, yangyuan@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fear of Cancer Recurrence Questionnaire (FCRQ7) (time frame: we use FCRQ7 to assess the change of FCR level from baseline to 4, 5, 8, 16 weeks follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05881889, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.

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