Lung CancersNCT06746948
Dyadic Psychological Stress Among Lung Cancer Patient-caregiver Dyads
An observational study of Lung Cancers and Lung Cancer Patients, run by Central South University at 1 site in China.
Trial summary
A lung cancer diagnosis has a huge impact on the psychological well-being of both patients and family caregivers. However, the current psychological stress status among dyads remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancers, Lung Cancer Patients
- What is being tested?
- dyadic psychological distress
- How many people
- 254 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Observational
- 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
Study population: hospitalized patients with lung cancer diagnosed by pathological section or cytology and a primary caregiver with a cumulative caregiving time of more than 33 hours; and a family member of the patient with lung cancer, such as spouse, children, parents, or other relatives.
Who may be able to join
- As for patients: aged≥18 years; hospitalized patients with lung cancer diagnosed by pathological section or cytology; and relatively stable condition, conscious, and able to express their willingness correctly.
- As for caregivers: aged ≥18 years; a primary caregiver with a cumulative caregiving time of more than 33 hours; and a family member of the patient with lung cancer, such as spouse, children, parents, or other relatives.
Who cannot join
- As for patients: people with a combination of other cancers or serious life-threatening diseases; the presence of audiological disorders or previous mental or cognitive disorders, such as anxiety disorder, or depression disorder; and receiving mental disorder treatments.
- As for caregivers: formal caregivers with employment relationships, such as nannies; the presence of audiological disorders or previous mental disorders or cognitive disorders, such as anxiety disorder, depression disorder; and receiving mental disorder treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Influencing Factors of the Dyadic Psychological Stress Among Patients With Lung Cancer and Their Family Caregivers: A Cross-Sectional Study
A lung cancer diagnosis has a huge impact on the psychological well-being of both patients and family caregivers. However, the current psychological stress status among dyads remains unclear. The investigators aimed to determine the prevalence of anxiety and depression and identify the factors that influence patients with lung cancer and their caregivers. The investigators will conduct a cross-sectional study of 254 dyads of lung cancer patients and family caregivers from four tertiary hospitals in Hunan Province, China from January 2021 to June 2021. Besides, the investigators used several instruments to collect data on depression, anxiety, illness perception, mindfulness, self-compassion, and dyadic coping. The independent samples t-test, analysis of one-way variance, Spearman's correlation analysis, and multiple linear regression analysis were employed. The results will recommend oncology nurses promptly screen high-risk patient-caregiver dyads who may suffer from severe psychological stress and provide them with targeted psychosocial interventions.
- Conditions
- Lung Cancers, Lung Cancer Patients
- Being tested
- dyadic psychological distress
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dyadic psychological distressOther
There is no intervention among the cross-sectional study.
| Study group | Role | What they receive |
|---|---|---|
| lung cancer caregiver-caregiver dyads | Not described Receives: Other: dyadic psychological distress |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression
The investigators measured dyadic depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9), which is a 9-item questionnaire. Scores range from 0 to 27, with higher scores indicating more severe depression. According to Kroenke et al.'s scoring of the PHQ-9, a score of 0-4 indicates no depression, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15-19 indicates moderate severe depression, and 20-27 indicates severe depression. The prevalence of depression is equal to the number of cases with a PHQ-9 score of 5 or greater divided by the total number of cases. Cronbach's alpha coefficients in this study were 0.85 and the KMO test value was 0.719, which showed good reliability and validity.
Measured: From enrollment through study completion, an average of 6 months
anxiety
The investigators assessed anxious symptoms using the Generalized Anxiety Disorder-7 scale (GAD-7), which is a 7-item questionnaire. Scores range from 0 to 21, with higher scores indicating more severe anxiety. According to Spitzer et al's evaluation of GAD-7 scale, a score of 0-4 indicates no anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. The prevalence of anxiety was defined as the number of cases with a GAD-7 score of 5 or greater divided by the total number of cases. Cronbach's alpha coefficients in this study were 0.93, respectively and KMO test value was 0.927, which showed good reliability and validity.
Measured: From enrollment through study completion, an average of 6 months
Secondary outcomes (4)
Illness Perception
The investigators administered the Brief Illness Perception Questionnaire (BIPQ) to assess the dyads' cognitive and emotional reactions to illness. The scale has 9 items, with items 1-5 assessing cognition, items 6 and 8 assessing emotional status, item 7 assessing comprehension, and item 9 being an open-ended question about causality of the cause of the illness. Each item is scored on a scale of 0 to 10, and the total score ranges from 0 to 80, with higher scores indicating more negative perceptions of the illness. Cronbach's alpha coefficient in this study was 0.77.
Measured: From enrollment through study completion, an average of 6 months
mindfulness
The investigators used the Mindful Attention Awareness Scale (MAAS) to assess the dyads' mindfulness tendencies. The scale consists of 15 items and each item is assigned a score from 1 to 6, with the scale ranging from "almost always" to "almost never", with higher scores indicating higher levels of awareness and attention to the present moment. Cronbach's alpha coefficient in this study was 0.92.
Measured: From enrollment through study completion, an average of 6 months
self-compassion
The dyadic self-compassion was assessed using the Self-compassion Scale (SCS), which includes six dimensions of self-kindness, self-criticism, common humanity, loneliness, stillness, and over-indulgence, with a total of 26 items, has a high re-test reliability (r=0.93) and internal consistency reliability (α=0.92). Cronbach's α coefficient in this study was 0.88.
Measured: From enrollment through study completion, an average of 6 months
dyadic coping
The Dyadic Coping Inventory (DCI)(32) was used to evaluate the coping ability of dyads. The Chinese version has a total of 37 items, including six dimensions: stress communication, support, negativity, empowerment coping, cooperation, and evaluation. A 5-point Likert scale was used, with higher scores indicating higher levels of positive dyadic coping, and the negative supportive coping items (items 7, 10, 11, 15, 22, 25, 26, 27) were reverse scored, with higher scores indicating higher levels of negative dyadic coping. A total score below 111 is considered low, a total score between 111 and 145 is considered moderate, and a total score above 145 is considered high. Cronbach's alpha coefficients in this study were 0.93.
Measured: From enrollment through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancersStudies 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
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 254 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
- NCT06746948
- Sponsor's protocol ID
- Dyadic psychological stress
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Li C, Zou J, Cheng FQ, Peng L, Deng LH, Wu PP, Gao SY, Xiong ZY, Zuo Y, Luo Y, Rao XH, Yuan B, Chen OY, Zhang JP. Prevalence and influencing factors of the dyadic psychological stress among patients with lung cancer and their family caregivers: a cross-sectional study. BMC Nurs. 2025 Jan 6;24(1):13. doi: 10.1186/s12912-024-02635-z.
PubMed 39762831
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Influencing Factors of the Dyadic Psychological Stress Among Patients With Lung Cancer and Their Family Caregivers: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06746948
- Acronym / sponsor ID
- Dyadic psychological stress
- Conditions
- Lung Cancers, Lung Cancer Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Dec 2024 (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.
A lung cancer diagnosis has a huge impact on the psychological well-being of both patients and family caregivers. However, the current psychological stress status among dyads remains unclear. The investigators aimed to determine the prevalence of anxiety and depression and identify the factors that influence patients with lung cancer and their caregivers. The investigators will conduct a cross-sectional study of 254 dyads of lung cancer patients and family caregivers from four tertiary hospitals in Hunan Province, China from January 2021 to June 2021. Besides, the investigators used several instruments to collect data on depression, anxiety, illness perception, mindfulness, self-compassion, and dyadic coping. The independent samples t-test, analysis of one-way variance, Spearman's correlation analysis, and multiple linear regression analysis were employed. The results will recommend oncology nurses promptly screen high-risk patient-caregiver dyads who may suffer from severe psychological stress and provide them with targeted psychosocial interventions.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer caregiver-caregiver dyads | – | Other: dyadic psychological distress |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized patients with lung cancer diagnosed by pathological section or cytology and a primary caregiver with a cumulative caregiving time of more than 33 hours; and a family member of the patient with lung cancer, such as spouse, children, parents, or other relatives.
Key inclusion criteria (2 listed)
- As for patients: aged≥18 years; hospitalized patients with lung cancer diagnosed by pathological section or cytology; and relatively stable condition, conscious, and able to express their willingness correctly.
- As for caregivers: aged ≥18 years; a primary caregiver with a cumulative caregiving time of more than 33 hours; and a family member of the patient with lung cancer, such as spouse, children, parents, or other relatives.
Key exclusion criteria (2 listed)
- As for patients: people with a combination of other cancers or serious life-threatening diseases; the presence of audiological disorders or previous mental or cognitive disorders, such as anxiety disorder, or depression disorder; and receiving mental disorder treatments.
- As for caregivers: formal caregivers with employment relationships, such as nannies; the presence of audiological disorders or previous mental disorders or cognitive disorders, such as anxiety disorder, depression disorder; and receiving mental disorder treatments.
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 |
|---|---|---|
| dyadic psychological distressThere is no intervention among the cross-sectional study. | Other | lung cancer caregiver-caregiver dyads |
Primary outcome
depression
Time frame: From enrollment through study completion, an average of 6 months
The investigators measured dyadic depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9), which is a 9-item questionnaire. Scores range from 0 to 27, with higher scores indicating more severe depression. According to Kroenke et al.'s scoring of the PHQ-9, a score of 0-4 indicates no depression, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15-19 indicates moderate severe depression, and 20-27 indicates severe depression. The prevalence of depression is equal to the number of cases with a PHQ-9 score of 5 or greater divided by the total number of cases. Cronbach's alpha coefficients in this study were 0.85 and the KMO test value was 0.719, which showed good reliability and validity.
anxiety
Time frame: From enrollment through study completion, an average of 6 months
The investigators assessed anxious symptoms using the Generalized Anxiety Disorder-7 scale (GAD-7), which is a 7-item questionnaire. Scores range from 0 to 21, with higher scores indicating more severe anxiety. According to Spitzer et al's evaluation of GAD-7 scale, a score of 0-4 indicates no anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. The prevalence of anxiety was defined as the number of cases with a GAD-7 score of 5 or greater divided by the total number of cases. Cronbach's alpha coefficients in this study were 0.93, respectively and KMO test value was 0.927, which showed good reliability and validity.
4 secondary outcomes
Illness Perception
Time frame: From enrollment through study completion, an average of 6 months
mindfulness
Time frame: From enrollment through study completion, an average of 6 months
self-compassion
Time frame: From enrollment through study completion, an average of 6 months
dyadic coping
Time frame: From enrollment through study completion, an average of 6 months
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 27 Dec 2024.
- Derived from this study: PubMed 39762831Li J, Li C, Zou J, Cheng FQ, Peng L, Deng LH, Wu PP, Gao SY, Xiong ZY, Zuo Y, Luo Y, Rao XH, Yuan B, Chen OY, Zhang JP. Prevalence and influencing factors of the dyadic psychological stress among patients with lung cancer and their family caregivers: a cross-sectional study. BMC Nurs. 2025 Jan 6;24(1):13. doi: 10.1186/s12912-024-02635-z.
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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?
An observational study of Lung Cancers and Lung Cancer Patients, 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 2 inclusion and 2 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 27 Dec 2024. 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 (time frame: From enrollment through study completion, an average of 6 months). 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 NCT06746948, which also lists 1 linked publication.
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 27 Dec 2024.