Cancer PatientsNCT05922423
Exploration of Management Model and Intervention Research on Fear of Cancer Recurrence
A study testing MBSR and health education in people with Cancer Patients, run by Nanfang Hospital, Southern Medical University.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Patients
- What is being tested?
- MBSR and health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- Patients with mental illness and consciousness disorders;
- Patients with cancer metastasis or recurrence
- End of life treatment for patients.
Trial locations and contacts
No sites are listed yet.
About this study
- 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.
- Conditions
- Cancer Patients
- Being tested
- MBSR, health education
- Keywords
- Mindfulness-Based Stress Reduction, fear of cancer recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
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 educationBehavioural
For cancer patients who have entered the comfort group, automatic tweets and health knowledge related to science popularization will be provided knowledge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of cancer recurrence
subjects' fear of cancer recurrence indicators at baseline
Measured: Baseline
Fear of cancer recurrence
Change in fear of cancer recurrence score compared to baseline at 8 weeks.
Measured: At the end of the 8-week intervention
Fear of cancer recurrence
Fear of cancer recurrence after one month of intervention
Measured: 1 mouth
Fear of cancer recurrence
Fear of cancer recurrence after three months of intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study startMar 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922423
- Sponsor's protocol ID
- NFEC-2023-008
- Status last verified
- Mar 2024
- First submitted
- 24 May 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Management Model and Intervention Research on Fear of Cancer Recurrence
- ClinicalTrials.gov ID
- NCT05922423
- Acronym / sponsor ID
- NFEC-2023-008
- Conditions
- Cancer Patients
- Keywords
- Mindfulness-Based Stress Reduction, fear of cancer recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR | Experimental | Behavioral: MBSRWeek 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 | Placebo comparator | Behavioral: health educationFor cancer patients who have entered the comfort group, automatic tweets and health knowledge related to science popularization will be provided knowledge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (3 listed)
- Patients with mental illness and consciousness disorders;
- Patients with cancer metastasis or recurrence
- End of life treatment for patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSRWeek 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. | Behavioural | MBSR |
| health educationFor cancer patients who have entered the comfort group, automatic tweets and health knowledge related to science popularization will be provided knowledge | Behavioural | health education |
Primary outcome
Fear of cancer recurrence
Time frame: Baseline
subjects' fear of cancer recurrence indicators at baseline
Fear of cancer recurrence
Time frame: At the end of the 8-week intervention
Change in fear of cancer recurrence score compared to baseline at 8 weeks.
Fear of cancer recurrence
Time frame: 1 mouth
Fear of cancer recurrence after one month of intervention
Fear of cancer recurrence
Time frame: 3 months
Fear of cancer recurrence after three months of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR and health education in people with Cancer Patients, run by Nanfang Hospital, Southern Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luo xian, Doctor (15521073773, 2443180803@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of cancer recurrence (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.