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

Primary Purpose

Cancer Patients

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MBSR
health education
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Patients focused on measuring Mindfulness-Based Stress Reduction, fear of cancer recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MBSR

    health education

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Fear of cancer recurrence
    subjects' fear of cancer recurrence indicators at baseline
    Fear of cancer recurrence
    Change in fear of cancer recurrence score compared to baseline at 8 weeks.
    Fear of cancer recurrence
    Fear of cancer recurrence after one month of intervention
    Fear of cancer recurrence
    Fear of cancer recurrence after three months of intervention

    Secondary Outcome Measures

    Full Information

    First Posted
    May 24, 2023
    Last Updated
    July 2, 2023
    Sponsor
    Nanfang Hospital, Southern Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05922423
    Brief Title
    Exploration of Management Model and Intervention Research on Fear of Cancer Recurrence
    Official Title
    Exploration of Management Model and Intervention Research on Fear of Cancer Recurrence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanfang Hospital, Southern Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Patients
    Keywords
    Mindfulness-Based Stress Reduction, fear of cancer recurrence

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MBSR
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    health education
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Name(s)
    MBSR
    Intervention Description
    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
    Intervention Name(s)
    health education
    Intervention Description
    For cancer patients who have entered the comfort group, automatic tweets and health knowledge related to science popularization will be provided knowledge
    Primary Outcome Measure Information:
    Title
    Fear of cancer recurrence
    Description
    subjects' fear of cancer recurrence indicators at baseline
    Time Frame
    Baseline
    Title
    Fear of cancer recurrence
    Description
    Change in fear of cancer recurrence score compared to baseline at 8 weeks.
    Time Frame
    At the end of the 8-week intervention
    Title
    Fear of cancer recurrence
    Description
    Fear of cancer recurrence after one month of intervention
    Time Frame
    1 mouth
    Title
    Fear of cancer recurrence
    Description
    Fear of cancer recurrence after three months of intervention
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luo xian, Doctor
    Phone
    15521073773
    Email
    2443180803@qq.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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