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

Sponsor
Nanfang Hospital, Southern Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05922423
Collaborator
(none)
130
Enrollment
2
Arms
16
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MBSR
  • Behavioral: health education
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Exploration of Management Model and Intervention Research on Fear of Cancer Recurrence
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Placebo Comparator: health education

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

Outcome Measures

Primary Outcome Measures

  1. Fear of cancer recurrence [Baseline]

    subjects' fear of cancer recurrence indicators at baseline

  2. Fear of cancer recurrence [At the end of the 8-week intervention]

    Change in fear of cancer recurrence score compared to baseline at 8 weeks.

  3. Fear of cancer recurrence [1 mouth]

    Fear of cancer recurrence after one month of intervention

  4. Fear of cancer recurrence [3 months]

    Fear of cancer recurrence after three months of intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Nanfang Hospital, Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Nanfang Hospital, Southern Medical University
ClinicalTrials.gov Identifier:
NCT05922423
Other Study ID Numbers:
  • NFEC-2023-008
First Posted:
Jun 28, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nanfang Hospital, Southern Medical University
Mindfulness-Based Stress Reduction
fear of cancer recurrence
Additional relevant MeSH terms:
Recurrence

Study Results

No Results Posted as of Jul 5, 2023