NCT06746948

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 15, 2024

Last Update Submit

December 22, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From enrollment through study completion, an average of 6 months

Secondary Outcomes (4)

  • Illness Perception

    From enrollment through study completion, an average of 6 months

  • mindfulness

    From enrollment through study completion, an average of 6 months

  • self-compassion

    From enrollment through study completion, an average of 6 months

  • dyadic coping

    From enrollment through study completion, an average of 6 months

Study Arms (1)

lung cancer caregiver-caregiver dyads

Other: dyadic psychological distress

Interventions

There is no intervention among the cross-sectional study.

lung cancer caregiver-caregiver dyads

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya School of Nursing

Changsha, 410013, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 15, 2024

First Posted

December 24, 2024

Study Start

January 1, 2021

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations