Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04795700
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2021-03-09
Brief Title:
Effects of MSC Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers
Sponsor:
Central South University
Organization:
Central South University
Study Overview
Official Title:
Effects of Mindfulness Self-Compassion Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The incidence and mortality of lung cancer ranks first among cancers in the world and the five-year survival rate of lung cancer patients is only 15 to 30 Lung cancer patients bear a great psychological pressure prone to anger isolation anxiety depression self-esteem and other psychological problems The incidence of psychological disorders in lung cancer patients was 242 to 734 A diagnosis of cancer not only causes physical and mental pain to the patient but also has a huge impact on the family and their caregivers As patientsprimary coping resources caregivers have to bear both physical and mental pressures Therefore it is worth to attention the mental health of lung cancer patients and their caregivers
With the further deepening of self-concept research and the integration of Buddhist thought and psychology the new concept of self-compassion was proposed and developed Self-compassion means that individuals treat themselves like their friends with a friendly and tolerant attitude maintains an objective and rational attitude towards the individuals own situation at all times thinks that pain is a common experience shared by others and everyone should be understood and sympathized At the same time self-compassion not only includes acceptance and affirmation of oneself but also connects oneself with others advocating that one should sympathize with oneself as sympathizing with others providing the possibility of emotional connection between patients and their caregivers Therefore the study of mindfulness and self-compassion is expected to provide a reference for improving the dyadic mental health of lung cancer patient-caregiver dyads in China
Mindfulness Self-Compassion MSC is a positive psychology intervention method that covers the concept of self-compassion developed by Neff and Germer on the basis of Mindfulness-based Stress Reduction MSC is a 25-hour weekly 8-week standardized training course Some studies have shown that MSC can promote the emotional health of cancer patients and buffer their mental symptoms
To sum up the current mindfulness self-compassion training program has been applied to some cancer patients and shows that the intervention has a positive effect while the research in China has only been initially applied in the student population and has not been applied in the field of cancer Therefore for lung cancer patient-caregiver dyad the researchers can learn from the experience of mindfulness self-compassion training and develop a dyadic mental health intervention program based on Chinese condition The current study aims to verify the effect of the dyadic mindfulness self-compassion intervention program for lung cancer patients and their caregivers and explore its mechanism
With the further deepening of self-concept research and the integration of Buddhist thought and psychology the new concept of self-compassion was proposed and developed Self-compassion means that individuals treat themselves like their friends with a friendly and tolerant attitude maintains an objective and rational attitude towards the individuals own situation at all times thinks that pain is a common experience shared by others and everyone should be understood and sympathized At the same time self-compassion not only includes acceptance and affirmation of oneself but also connects oneself with others advocating that one should sympathize with oneself as sympathizing with others providing the possibility of emotional connection between patients and their caregivers Therefore the study of mindfulness and self-compassion is expected to provide a reference for improving the dyadic mental health of lung cancer patient-caregiver dyads in China
Mindfulness Self-Compassion MSC is a positive psychology intervention method that covers the concept of self-compassion developed by Neff and Germer on the basis of Mindfulness-based Stress Reduction MSC is a 25-hour weekly 8-week standardized training course Some studies have shown that MSC can promote the emotional health of cancer patients and buffer their mental symptoms
To sum up the current mindfulness self-compassion training program has been applied to some cancer patients and shows that the intervention has a positive effect while the research in China has only been initially applied in the student population and has not been applied in the field of cancer Therefore for lung cancer patient-caregiver dyad the researchers can learn from the experience of mindfulness self-compassion training and develop a dyadic mental health intervention program based on Chinese condition The current study aims to verify the effect of the dyadic mindfulness self-compassion intervention program for lung cancer patients and their caregivers and explore its mechanism
Detailed Description:
The study was a single blind follow-up randomized controlled trial Researchers recruited subjects from two general tertiary hospitals in Changsha Hunan province China And the whole trail was on the basis of the CONSORT statements The two hospitals provided similar conventional care for lung cancer patients Study procedures were approved by the institutional review boards of all participating centers before data collection began All patients were screened by researchers for eligibility and then enrolled in the study if eligible and if the provided consent
Potential eligible participants were identified by researchers according to medical records at the colorectal surgery unit in each hospital The participants were recruited with informed consent and researchers explained the study purposes procedures benefits and risks involved orally The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list A sequentially numbered and opaque sealed envelope system was used by a non-investigator The generated random numbers were put into consecutively numbered and opaque sealed envelopes When enrolling and randomising a new participant the enrolling investigators opened the sealed envelope after participants name was written on next available envelopes the enrolling investigators were blinded to the trial design and study hypotheses
The researcher will recruit 74 lung cancer patient-caregiver dyads and randomly divide them into 2 groups the control group the dyadic intervention group Among them patients in the control group and caregivers received routine psychological care programs patients in the intervention group had access to conventional care in addition to receiving the 8-week dyadic MSC intervention sessions The intervention was provided by trained nurses including one researcher and one MSC therapist The researcher was regarded as primary leader of the intervention sessions The leader informed patients of the schedule for each session using the educational manualCaring for ourselves we are together developed by psychologists nursing managers experienced MSC therapist oncology Nurse and researchers
The MSC techniques include body scanning breathing meditation sitting meditation walking meditation loving-kindness practice and self-compassion writing expression Intensive training once a week 1 hour each time encourage students to use 15-20 minutes a day to learn these skills the total training time per week is 25 hours The intervention is mainly out-of-hospital intervention supplemented by short-term in-hospital intervention 1-2 weeks adjusted according to the patients hospital stay The in-hospital stage focuses on guiding the research subjects to understand the content of mindful self-compassion and emotions and conduct basic mindful self-compassion training the outside of the hospital focuses on the maintenance of mindful self-compassion training and the promotion of mindful life
Data were collected by a research assistant who was blind to the study design and allocation of participants At baseline before randomization sociodemographic and clinical characteristics were collected from medical records and personal interviews The two groups of participants completed surveys after each follow-up via face to face interviews at baseline T0 and immediately after intervention T1 The next two evaluations were performed at 1-month T2 and 3-months T3 after intervention via telephone contact
Potential eligible participants were identified by researchers according to medical records at the colorectal surgery unit in each hospital The participants were recruited with informed consent and researchers explained the study purposes procedures benefits and risks involved orally The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list A sequentially numbered and opaque sealed envelope system was used by a non-investigator The generated random numbers were put into consecutively numbered and opaque sealed envelopes When enrolling and randomising a new participant the enrolling investigators opened the sealed envelope after participants name was written on next available envelopes the enrolling investigators were blinded to the trial design and study hypotheses
The researcher will recruit 74 lung cancer patient-caregiver dyads and randomly divide them into 2 groups the control group the dyadic intervention group Among them patients in the control group and caregivers received routine psychological care programs patients in the intervention group had access to conventional care in addition to receiving the 8-week dyadic MSC intervention sessions The intervention was provided by trained nurses including one researcher and one MSC therapist The researcher was regarded as primary leader of the intervention sessions The leader informed patients of the schedule for each session using the educational manualCaring for ourselves we are together developed by psychologists nursing managers experienced MSC therapist oncology Nurse and researchers
The MSC techniques include body scanning breathing meditation sitting meditation walking meditation loving-kindness practice and self-compassion writing expression Intensive training once a week 1 hour each time encourage students to use 15-20 minutes a day to learn these skills the total training time per week is 25 hours The intervention is mainly out-of-hospital intervention supplemented by short-term in-hospital intervention 1-2 weeks adjusted according to the patients hospital stay The in-hospital stage focuses on guiding the research subjects to understand the content of mindful self-compassion and emotions and conduct basic mindful self-compassion training the outside of the hospital focuses on the maintenance of mindful self-compassion training and the promotion of mindful life
Data were collected by a research assistant who was blind to the study design and allocation of participants At baseline before randomization sociodemographic and clinical characteristics were collected from medical records and personal interviews The two groups of participants completed surveys after each follow-up via face to face interviews at baseline T0 and immediately after intervention T1 The next two evaluations were performed at 1-month T2 and 3-months T3 after intervention via telephone contact
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None