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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05922423
Other study ID # NFEC-2023-008
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date December 2024

Study information

Verified date March 2024
Source Nanfang Hospital, Southern Medical University
Contact Luo xian, Doctor
Phone 15521073773
Email 2443180803@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

1. Through cross-sectional investigation and research, construct an fear of cancer recurrence warning model to identify and screen high fear of cancer recurrencecancer populations, in order to identify predictive factors for high fear of cancer recurrence, study how cancer patients develop susceptibility to fear of cancer recurrence during the diagnosis and treatment process, including which participating factors, explore the development trajectory of fear of cancer recurrence, and effectively prevent the occurrence of high-level fear of cancer recurrence. 2. Through randomized controlled trials, conduct a study on mindfulness and stress reduction psychosocial intervention for high-level fear of cancer recurrence patients, verify the effectiveness of psychosocial intervention measures targeting domestic cancer populations, and improve standardized intervention methods, intervention time, and treatment content.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 130
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults aged = 18 years old - Consistent with pathological diagnosis of cancer - Able to understand and comply with research protocols - Written informed consent can be provided - Own and know how to use smart ·terminals (such as smartphones, tablets, computers, etc.) Exclusion Criteria: - Patients with mental illness and consciousness disorders; - Patients with cancer metastasis or recurrence - End of life treatment for patients.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MBSR
Week 1: Introduce mindfulness theory knowledge to participants and guide them to engage in mindfulness breathing training; Week 2: Sitting meditation, explaining the essence of meditation and practicing with music; Week 3: Explain the connotation of walking meditation, inform the participants of precautions, and guide them to practice; Week 4: Explain the connotation and requirements of body scanning, guide participants in practice; Week 5: Introduce the connotation of hatha yoga and guide participants to practice; Week 6: Explain the meaning of mindfulness sounds and thoughts, guide participants to practice; Week 7: Explain the characteristics of non selective perception, combined with music practice; Week 8: Emphasize mindfulness to promote health, encourage participants to practice internalization, and develop into their own patterns.
health education
For cancer patients who have entered the comfort group, automatic tweets and health knowledge related to science popularization will be provided knowledge

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital, Southern Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary Fear of cancer recurrence subjects' fear of cancer recurrence indicators at baseline Baseline
Primary Fear of cancer recurrence Change in fear of cancer recurrence score compared to baseline at 8 weeks. At the end of the 8-week intervention
Primary Fear of cancer recurrence Fear of cancer recurrence after one month of intervention 1 mouth
Primary Fear of cancer recurrence Fear of cancer recurrence after three months of intervention 3 months
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