Exploration of Management Model and Intervention Research on Fear of Cancer Recurrence

NCT ID: NCT05922423

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-12-31

Brief 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.

Conditions

Cancer Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

MBSR

Intervention Type: BEHAVIORAL

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

Group Type: PLACEBO_COMPARATOR

health education

Intervention Type: BEHAVIORAL

For cancer patients who have entered the comfort group, automatic tweets and health knowledge related to science popularization will be provided knowledge

Interventions

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.

Intervention Type: BEHAVIORAL

health education

For cancer patients who have entered the comfort group, automatic tweets and health knowledge related to science popularization will be provided knowledge

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Luo xian, Doctor

Role: CONTACT

2443180803@qq.com

15521073773

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NFEC-2023-008

Identifier Type: -

Identifier Source: org_study_id