Depression, AnxietyNCT04795700
Effects of MSC Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers
A study testing MSC intervention in people with Depression, Anxiety, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- MSC intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with lung cancer by pathological biopsy or cytology;
- The disease condition is relatively stable;
- Must be conscious, with normal communication ability;
- Must be volunteered to join the study.
- A primary caregiver designated by a lung cancer patient who has been included in this study, with a cumulative care time of more than 72 hours;
- One of the family members of a hospitalized lung cancer patient, such as their spouse, children, parents or other relatives
- must be conscious, with normal communication ability;
- must be volunteered to join the study.
Who cannot join
- Share a hospital room with a current study participant;
- With other types of cancer;
- Alcoholics and/or drug addicts;
- Disabilities and cannot take care of themselves.
- For caregivers
- Have an employment relationship with the patient, such as nurses and nanny；
- Alcoholics and/or drug addicts;
- Disabilities and cannot take care of themselves.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mindfulness Self-Compassion Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers: a Randomized Controlled Trial
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 24.2 to 73.4%. 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 patients'primary 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 individual's 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.
Read more
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 2.5-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.
Read the 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 participant's 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 manual'Caring 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 2.5 hours. The intervention is mainly out-of-hospital intervention, supplemented by short-term in-hospital intervention (1-2 weeks, adjusted according to the patient's 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.
- Conditions
- Depression, Anxiety
- Being tested
- MSC intervention
- Keywords
- lung cancer patients, caregivers, mindfulness, self-compassion, resilience, intimacy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC interventionBehavioural
Patients in the intervention group had access to conventional care, in addition to receiving the 8 weeks MSC intervention sessions. The intervention was provided by trained nurses, including one researcher and one MSC therapist. The intervention is mainly out-of-hospital intervention, supplemented by short-term in-hospital intervention. Among them, the first and second weeks of the intervention project in the hospital phase focus on guiding the research subjects to understand the content of mindful self-compassion and emotions, and carry out basic mindful self-compassion training; the content of the 3-8th week of the intervention program outside the hospital, Focus on the maintenance of mindful self-compassion training and the promotion of mindful life. Each face-to-face group contact lasted about 1 hour, depending on the complexity of the patients' problems.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | Patients in the intervention group receiving the 8 weeks MSC intervention sessions. Receives: Behavioral: MSC intervention |
| The control group | No intervention | No interventions except conventional care were performed for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression of lung cancer patients and their caregivers
Patient Health Questionnaire 2-item Depression Screen (PHQ-2) is used to initially screen the high-risk groups of depression. The score of each item ranges from "0 means no at all" to "3 points means almost every day". The total score is equal to the sum of the items is 6 points, and 3 points or more can be considered as depressed. . PHQ-2 has good reliability and validity in the screening of depression in patients with cardiovascular diseases. Cronbach's α coefficient is 0.809, and the test-retest reliability coefficient is 0.882.
Measured: 3-months (T3) after intervention
Anxiety of lung cancer patients and their caregivers
Generalized Anxiety Disorder-7 (GAD-7) is used to screen for Generalized Anxiety. There are 7 items in total. It is scored from 0 (never) to 3 (almost every day). , The higher the score, the more serious the anxiety. According to Spitzer's assessment of GAD-7 scale, 5 is divided into the cut-off value of symptom-positive samples.
Measured: 3-months (T3) after intervention
Secondary outcomes (1)
Self-compassion of lung cancer patients and their caregivers
The Self-compassion Scale has good adaptability in both healthy people and patients with chronic diseases. The scale contains 6 subscales of self-tolerance, self-criticism, universal humanity, loneliness, mindfulness and over-identification, with a total of 26 items. Each item uses a Likert 5-level score, ranging from "never" to "always". The score is 1 to 5, and the total score is 26 to 130. The three dimensions of self-criticism, loneliness, and over-identification use the reverse scoring method. The Cronbach coefficient of the scale is 0.84, and the test-retest reliability is 0.89.
Measured: 3-months (T3) after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Aug 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- 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
- Model description
- Patients in the intervention group had access to conventional care, in addition to receiving the follow-up 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 manual 'Caring for ourselves, we are together' (developed by psychologists, nursing managers, experienced oncology nurses, and researchers). No interventions were performed for the control group participants during the study. However, these patients received conventional care in the oncology departments according to the two hospitals' similar nursing guidelines.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan LI, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795700
- Sponsor's protocol ID
- MSC
- Status last verified
- Dec 2022
- First submitted
- 9 Mar 2021
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The process of data collection cost a lot of human and material resources, some of the data was privacy information of participants, and so on. Considering this, it is improper to share these data.
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Mitsudomi T, Takahashi T. [Genetic abnormalities in lung cancer and their prognostic implications]. Gan To Kagaku Ryoho. 1996 Jul;23(8):990-6. Japanese.
PubMed 8687234Hamer M, Chida Y, Molloy GJ. Psychological distress and cancer mortality. J Psychosom Res. 2009 Mar;66(3):255-8. doi: 10.1016/j.jpsychores.2008.11.002. Epub 2009 Jan 16.
PubMed 19232239Qureshi F, Shafi A, Ali S, Siddiqui N. Clinical predictors of anticipatory emesis in patients treated with chemotherapy at a tertiary care cancer hospital. Pak J Med Sci. 2016 Mar-Apr;32(2):337-40. doi: 10.12669/pjms.322.9493.
PubMed 27182235Chad-Friedman E, Coleman S, Traeger LN, Pirl WF, Goldman R, Atlas SJ, Park ER. Psychological distress associated with cancer screening: A systematic review. Cancer. 2017 Oct 15;123(20):3882-3894. doi: 10.1002/cncr.30904. Epub 2017 Aug 22.
PubMed 28833054Thomas BC, NandaMohan V, Nair MK, Pandey M. Gender, age and surgery as a treatment modality leads to higher distress in patients with cancer. Support Care Cancer. 2010 Feb;19(2):239-50. doi: 10.1007/s00520-009-0810-4. Epub 2010 Feb 23.
PubMed 20174987Lee YH, Liao YC, Shun SC, Lin KC, Liao WY, Chang PH, Jhang SY, Yu CJ, Yang PC, Hsieh PY, Lai YH. Trajectories of caregiver burden and related factors in family caregivers of patients with lung cancer. Psychooncology. 2018 Jun;27(6):1493-1500. doi: 10.1002/pon.4678. Epub 2018 Mar 30.
PubMed 29476636Talbot F, Theriault J, French DJ. Self-Compassion: Evaluation of a Psychoeducational Website. Behav Cogn Psychother. 2017 Mar;45(2):198-203. doi: 10.1017/S1352465816000230. Epub 2016 Jun 15.
PubMed 27302088Sung MR, Patel MV, Djalalov S, Le LW, Shepherd FA, Burkes RL, Feld R, Lin S, Tudor R, Leighl NB. Evolution of Symptom Burden of Advanced Lung Cancer Over a Decade. Clin Lung Cancer. 2017 May;18(3):274-280.e6. doi: 10.1016/j.cllc.2016.12.010. Epub 2017 Jan 5.
PubMed 28185791Lin S, Chen Y, Yang L, Zhou J. Pain, fatigue, disturbed sleep and distress comprised a symptom cluster that related to quality of life and functional status of lung cancer surgery patients. J Clin Nurs. 2013 May;22(9-10):1281-90. doi: 10.1111/jocn.12228.
PubMed 23574291Schellekens MPJ, Karremans JC, van der Drift MA, Molema J, van den Hurk DGM, Prins JB, Speckens AEM. Are Mindfulness and Self-Compassion Related to Psychological Distress and Communication in Couples Facing Lung Cancer? A Dyadic Approach. Mindfulness (N Y). 2017;8(2):325-336. doi: 10.1007/s12671-016-0602-0. Epub 2016 Sep 6.
PubMed 28360948Toplu-Demirtas E, Kemer G, Pope AL, Moe JL. Self-compassion matters: The relationships between perceived social support, self-compassion, and subjective well-being among LGB individuals in Turkey. J Couns Psychol. 2018 Apr;65(3):372-382. doi: 10.1037/cou0000261.
PubMed 29672086Manne SL, Siegel S, Kashy D, Heckman CJ. Cancer-specific Relationship Awareness, Relationship Communication, and Intimacy Among Couples Coping with Early Stage Breast Cancer. J Soc Pers Relat. 2014 May;31(3):314-334. doi: 10.1177/0265407513494950.
PubMed 25242854Rusu PP, Hilpert P, Beach SR, Turliuc MN, Bodenmann G. Dyadic coping mediates the association of sanctification with marital satisfaction and well-being. J Fam Psychol. 2015 Dec;29(6):843-9. doi: 10.1037/fam0000108. Epub 2015 Jul 6.
PubMed 26147936Li J, Zhou T, Li C, Zou J, Zhang J, Yuan B, Zhang J. Development of a dyadic mindfulness self-compassion intervention for patients with lung cancer and their family caregivers: A multi-method study. Asia Pac J Oncol Nurs. 2024 Nov 15;12:100622. doi: 10.1016/j.apjon.2024.100622. eCollection 2025 Dec.
PubMed 39712511
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Self-Compassion Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04795700
- Acronym / sponsor ID
- MSC
- Conditions
- Depression, Anxiety
- Keywords
- lung cancer patients, caregivers, mindfulness, self-compassion, resilience, intimacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 12 Mar 2021 (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.
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 24.2 to 73.4%. 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 patients'primary 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 individual's 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 2.5-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 participant's 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 manual'Caring 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 2.5 hours. The intervention is mainly out-of-hospital intervention, supplemented by short-term in-hospital intervention (1-2 weeks, adjusted according to the patient's 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients in the intervention group had access to conventional care, in addition to receiving the follow-up 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 manual 'Caring for ourselves, we are together' (developed by psychologists, nursing managers, experienced oncology nurses, and researchers). No interventions were performed for the control group participants during the study. However, these patients received conventional care in the oncology departments according to the two hospitals' similar nursing guidelines.
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: MSC interventionPatients in the intervention group receiving the 8 weeks MSC intervention sessions. |
| The control group | No intervention | –No interventions except conventional care were performed for the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with lung cancer by pathological biopsy or cytology;
- The disease condition is relatively stable;
- Must be conscious, with normal communication ability;
- Must be volunteered to join the study.
- A primary caregiver designated by a lung cancer patient who has been included in this study, with a cumulative care time of more than 72 hours;
Key exclusion criteria (8 listed)
- Share a hospital room with a current study participant;
- With other types of cancer;
- Alcoholics and/or drug addicts;
- Disabilities and cannot take care of themselves.
- For caregivers
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 |
|---|---|---|
| MSC interventionPatients in the intervention group had access to conventional care, in addition to receiving the 8 weeks MSC intervention sessions. The intervention was provided by trained nurses, including one researcher and one MSC therapist. The intervention is mainly out-of-hospital intervention, supplemented by short-term in-hospital intervention. Among them, the first and second weeks of the intervention project in the hospital phase focus on guiding the research subjects to understand the content of mindful self-compassion and emotions, and carry out basic mindful self-compassion training; the content of the 3-8th week of the intervention program outside the hospital, Focus on the maintenance of mindful self-compassion training and the promotion of mindful life. Each face-to-face group contact lasted about 1 hour, depending on the complexity of the patients' problems. | Behavioural | The intervention group |
Primary outcome
Depression of lung cancer patients and their caregivers
Time frame: 3-months (T3) after intervention
Patient Health Questionnaire 2-item Depression Screen (PHQ-2) is used to initially screen the high-risk groups of depression. The score of each item ranges from "0 means no at all" to "3 points means almost every day". The total score is equal to the sum of the items is 6 points, and 3 points or more can be considered as depressed. . PHQ-2 has good reliability and validity in the screening of depression in patients with cardiovascular diseases. Cronbach's α coefficient is 0.809, and the test-retest reliability coefficient is 0.882.
Anxiety of lung cancer patients and their caregivers
Time frame: 3-months (T3) after intervention
Generalized Anxiety Disorder-7 (GAD-7) is used to screen for Generalized Anxiety. There are 7 items in total. It is scored from 0 (never) to 3 (almost every day). , The higher the score, the more serious the anxiety. According to Spitzer's assessment of GAD-7 scale, 5 is divided into the cut-off value of symptom-positive samples.
1 secondary outcome
Self-compassion of lung cancer patients and their caregivers
Time frame: 3-months (T3) after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 8687234Mitsudomi T, Takahashi T. [Genetic abnormalities in lung cancer and their prognostic implications]. Gan To Kagaku Ryoho. 1996 Jul;23(8):990-6. Japanese.
- Background: PubMed 19232239Hamer M, Chida Y, Molloy GJ. Psychological distress and cancer mortality. J Psychosom Res. 2009 Mar;66(3):255-8. doi: 10.1016/j.jpsychores.2008.11.002. Epub 2009 Jan 16.
- Background: PubMed 27182235Qureshi F, Shafi A, Ali S, Siddiqui N. Clinical predictors of anticipatory emesis in patients treated with chemotherapy at a tertiary care cancer hospital. Pak J Med Sci. 2016 Mar-Apr;32(2):337-40. doi: 10.12669/pjms.322.9493.
- Background: PubMed 28833054Chad-Friedman E, Coleman S, Traeger LN, Pirl WF, Goldman R, Atlas SJ, Park ER. Psychological distress associated with cancer screening: A systematic review. Cancer. 2017 Oct 15;123(20):3882-3894. doi: 10.1002/cncr.30904. Epub 2017 Aug 22.
- Background: PubMed 20174987Thomas BC, NandaMohan V, Nair MK, Pandey M. Gender, age and surgery as a treatment modality leads to higher distress in patients with cancer. Support Care Cancer. 2010 Feb;19(2):239-50. doi: 10.1007/s00520-009-0810-4. Epub 2010 Feb 23.
- Background: PubMed 29476636Lee YH, Liao YC, Shun SC, Lin KC, Liao WY, Chang PH, Jhang SY, Yu CJ, Yang PC, Hsieh PY, Lai YH. Trajectories of caregiver burden and related factors in family caregivers of patients with lung cancer. Psychooncology. 2018 Jun;27(6):1493-1500. doi: 10.1002/pon.4678. Epub 2018 Mar 30.
- Background: PubMed 27302088Talbot F, Theriault J, French DJ. Self-Compassion: Evaluation of a Psychoeducational Website. Behav Cogn Psychother. 2017 Mar;45(2):198-203. doi: 10.1017/S1352465816000230. Epub 2016 Jun 15.
- Background: PubMed 28185791Sung MR, Patel MV, Djalalov S, Le LW, Shepherd FA, Burkes RL, Feld R, Lin S, Tudor R, Leighl NB. Evolution of Symptom Burden of Advanced Lung Cancer Over a Decade. Clin Lung Cancer. 2017 May;18(3):274-280.e6. doi: 10.1016/j.cllc.2016.12.010. Epub 2017 Jan 5.
- Background: PubMed 23574291Lin S, Chen Y, Yang L, Zhou J. Pain, fatigue, disturbed sleep and distress comprised a symptom cluster that related to quality of life and functional status of lung cancer surgery patients. J Clin Nurs. 2013 May;22(9-10):1281-90. doi: 10.1111/jocn.12228.
- Background: PubMed 28360948Schellekens MPJ, Karremans JC, van der Drift MA, Molema J, van den Hurk DGM, Prins JB, Speckens AEM. Are Mindfulness and Self-Compassion Related to Psychological Distress and Communication in Couples Facing Lung Cancer? A Dyadic Approach. Mindfulness (N Y). 2017;8(2):325-336. doi: 10.1007/s12671-016-0602-0. Epub 2016 Sep 6.
- Background: PubMed 29672086Toplu-Demirtas E, Kemer G, Pope AL, Moe JL. Self-compassion matters: The relationships between perceived social support, self-compassion, and subjective well-being among LGB individuals in Turkey. J Couns Psychol. 2018 Apr;65(3):372-382. doi: 10.1037/cou0000261.
- Individual participant dataSharing planned: No. The process of data collection cost a lot of human and material resources, some of the data was privacy information of participants, and so on. Considering this, it is improper to share these data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSC intervention in people with Depression, Anxiety, run by Central South University at 1 site in China.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression of lung cancer patients and their caregivers (time frame: 3-months (T3) after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04795700, which also lists 15 linked publications.
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 16 Dec 2022.