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

NCT05922423 | Not Yet Recruiting

• 1 other identifier: NFEC-2023-008
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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

Keywords

Mindfulness-Based Stress Reduction; fear of cancer recurrence

Outcome Measures

Primary Outcomes (4)

• Fear of cancer recurrence

  subjects' fear of cancer recurrence indicators at baseline

  Baseline

• 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

• Fear of cancer recurrence

  Fear of cancer recurrence after one month of intervention

  1 mouth

• Fear of cancer recurrence

  Fear of cancer recurrence after three months of intervention

  3 months

Study Arms (2)

MBSR

EXPERIMENTAL

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.

Behavioral: MBSR

health education

PLACEBO COMPARATOR

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

Behavioral: health education

Interventions

MBSR 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.

MBSR

health education BEHAVIORAL

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

health education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• Patients with mental illness and consciousness disorders;
• Patients with cancer metastasis or recurrence
• End of life treatment for patients.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Central Study Contacts

Luo xian, Doctor

CONTACT

15521073773; 2443180803@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 28, 2023
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share