- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06746948
Dyadic Psychological Stress Among Lung Cancer Patient-caregiver Dyads
December 22, 2024 updated by: Juan LI, Central South University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
254
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Changsha, China, 410013
- Xiangya School of Nursing
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
lung cancer caregiver-caregiver dyads
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There is no intervention among the cross-sectional study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment through study completion, an average of 6 months
|
|
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.
|
From enrollment through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Illness Perception
Time Frame: From enrollment through study completion, an average of 6 months
|
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.
|
From enrollment through study completion, an average of 6 months
|
|
mindfulness
Time Frame: From enrollment through study completion, an average of 6 months
|
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.
|
From enrollment through study completion, an average of 6 months
|
|
self-compassion
Time Frame: From enrollment through study completion, an average of 6 months
|
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.
|
From enrollment through study completion, an average of 6 months
|
|
dyadic coping
Time Frame: From enrollment through study completion, an average of 6 months
|
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.
|
From enrollment through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
December 15, 2024
First Submitted That Met QC Criteria
December 18, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 22, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dyadic psychological stress
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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