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Lung Cancer (NSCLC)FSTNCT07749443

Construction and Empirical Study of Indirect Intervention Model for Protective Medical Lung Cancer Patients Based on Family System Theory

A study testing Caregiver cognitive intervention based on printed handbook, Graded information disclosure strategies and Routine perioperative health education in people with Lung Cancer (NSCLC), run by Anhui Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To clarify the irrational cognition of family caregivers of lung cancer patients at various perioperative stages under the background of protective medical treatment, construct an indirect intervention model for lung cancer patients, and evaluate its clinical efficacy. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Lung Cancer (NSCLC)
What is being tested?
Caregiver cognitive intervention based on printed handbook, Graded information disclosure strategies and Routine perioperative health education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
1 May 2025to 31 Mar 2026
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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • (1)Patients
  • Eligible for radical lung cancer surgery confirmed by clinicians in accordance with lung cancer clinical guidelines;
  • Aged over 18 years old;
  • No history of drug or alcohol dependence, and no use of contraceptives or hormones within the past three months;
  • Fully informed of the study, signed informed consent and volunteered to participate.
  • (2)Family Caregivers
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  • <!-- -->
  • Spouses, adult children or other relatives who provide long-term unpaid daily care and companionship for patients;
  • Aged over 18 years old;
  • No history of drug or alcohol dependence, and no use of contraceptives or hormones within the past three months;
  • Fully informed of the study, signed informed consent and volunteered to participate.

Who cannot join

  • (1)Patients:
  • Patients who do not meet the surgical indications as evaluated by clinicians;
  • Patients with immune system diseases;
  • Patients with a history of mental illness or severe cognitive impairment.
  • (2)Family Caregivers：
  • <!-- -->
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  • Caregivers with severe organic lesions themselves;
  • Caregivers who have experienced other major life events recently;
  • Caregivers with a history of mental illness or severe cognitive impairment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Anhui Provincial Hospital

    Hefei, Anhui

Other trials in China

About this study

To clarify the irrational cognition of family caregivers of lung cancer patients at various perioperative stages under the background of protective medical treatment, construct an indirect intervention model for lung cancer patients, and evaluate its clinical efficacy.

To develop popularizable cognitive intervention tools and formulate practical cognitive intervention strategies, so as to relieve perioperative stress responses among lung cancer patients and their family caregivers.

To provide reliable evidence and research directions for carrying out comprehensive and systematic interventions on perioperative stress responses in lung cancer patients and their family caregivers in clinical practice in the future.

Being tested
Caregiver cognitive intervention based on printed handbook, Graded information disclosure strategies, Routine perioperative health education, Routine health education
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caregiver cognitive intervention based on printed handbookBehavioural

    Caregivers receive standardized cognitive intervention based on printed handbook. The handbook includes disease knowledge, symptom management strategies and psychological coping skills. One-on-one guidance is provided during hospitalization, followed by regular follow-up.

  • Graded information disclosure strategiesBehavioural

    Nurses adopt graded information disclosure strategies, combine health handbook to carry out individualized guidance about postoperative cough, sleep regulation and emotional adaptation.

  • Routine perioperative health educationBehavioural

    Patients receive routine perioperative health education following hospital standard nursing procedures . No targeted graded information communication and spec

  • Routine health educationBehavioural

    Caregivers receive routine health education according to standard hospital nursing procedures, without additional cognitive intervention handbook and targeted guidance.

Study groups in NCT07749443
Study groupRoleWhat they receive
Caregiver Control GroupActive comparatorRoutine Care
Receives: Behavioral: Routine health education
Caregiver Intervention GroupExperimentalCognitive Intervention+Routine Care
Receives: Behavioral: Caregiver cognitive intervention based on printed handbook
Patient Control GroupActive comparatorRoutine Care
Receives: Behavioral: Routine perioperative health education
Patient Intervention GroupExperimentalCaregiver Cognitive Intervention+Routine Care
Receives: Behavioral: Graded information disclosure strategies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decisional Conflict（DCS）

    Patient decisional conflict level is assessed using the validated 16-item Decisional Conflict Scale (DCS). Each item adopts a 5-point Likert rating with partial reverse scoring (1=strongly agree, 2=agree, 3=uncertain, 4=disagree, 5=strongly disagree). The mean raw score (1-5) of all items is linearly converted to a standardized total score of 0-100 via formula: (mean score-1)×25. Higher total scores indicate greater decisional conflict.

    Measured: 1 day before operation, 1 day after operation, and 1 month after discharge

  2. Functional status(FACT-L)

    Patient functional status and cancer-specific quality of life are measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L), containing 27 items across 4 general domains plus 9 lung-cancer-specific items. Each item is scored 0-4 points, domain scores are summed separately, and the overall total score ranges 0-144. Higher total scores represent better postoperative functional status and quality of life.

    Measured: 1 day before operation, 1 day after operation, and 1 month after discharge

Secondary outcomes (5)

  1. Anxiety and Depression(HADS)

    Anxiety and depressive symptoms are evaluated with the Hospital Anxiety and Depression Scale (HADS), consisting of 7 anxiety items and 7 depression items. Each single item is scored 0-3 points; the anxiety subscale and depression subscale are calculated independently, with each subscale total ranging 0-21. Higher subscale scores correspond to more severe anxiety or depressive symptoms.

    Measured: 1 day before operation, 1 day after operation, and 1 month after discharge

  2. Blood Pressure

    Measured: 1 day before operation, 1 day after operation, and 1 month after discharge

  3. Resilience(CD-RISC)

    Psychological resilience is assessed using the validated 25-item Connor-Davidson Resilience Scale (CD-RISC). Each item is rated on a 5-point Likert scale (0=not true at all, 1=rarely true, 2=sometimes true, 3=often true, 4=true nearly all the time). All item scores are summed directly for the aggregate total score (range 0-100). A higher total score reflects better psychological resilience.

    Measured: 1 day before operation, 1 day after operation, and 1 month after discharge

  4. BMI

    Measured: 1 day before operation, 1 day after operation, and 1 month after discharge

  5. Lymphocyte count

    Lymphocyte count is tested by routine peripheral venous blood analysis, unit: ×10⁹/L.

    Measured: 1 day before operation, 1 day after operation, and 1 month after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start1 May 2025
  3. Primary completion31 Mar 2026
  4. Study completion31 Mar 2026

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07749443
Sponsor's protocol ID
83243443
Other IDs
2023AH050616
Acronym
FST
Status last verified
May 2025
First submitted
31 Jul 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data (IPD) will not be shared. The data involves sensitive clinical information of patients. There is no pre-established plan for data sharing with external researchers at the current stage

Publications

  • Mao S, Lu H, Zhang Y, Yu J, Li X, Peng J, Liang Y. Evaluation of Psychosocial Pathways to Family Adaptation of Chinese Patients With Liver Cancer Using the McCubbin's Family Resilience Model. Front Psychiatry. 2021 Dec 16;12:703137. doi: 10.3389/fpsyt.2021.703137. eCollection 2021.

    PubMed 34975555

Questions about this trial

What is this clinical trial studying?

A study testing Caregiver cognitive intervention based on printed handbook, Graded information disclosure strategies and Routine perioperative health education in people with Lung Cancer (NSCLC), run by Anhui Medical 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 11 inclusion and 9 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 6 Aug 2026. 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?

Decisional Conflict（DCS） (time frame: 1 day before operation, 1 day after operation, and 1 month after discharge). 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 NCT07749443, 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 6 Aug 2026.

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