CClinicalTrials.gg
CompletedNCT07749443FSTUpdated Aug 6, 2026

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

An interventional study of Caregiver cognitive intervention based on printed handbook and Graded information disclosure strategies in Lung Cancer (NSCLC), sponsored by Anhui Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Anhui Medical University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled May 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 160 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Anhui Medical University is the lead sponsor of 102 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • (1)Patients

    1. Eligible for radical lung cancer surgery confirmed by clinicians in accordance with lung cancer clinical guidelines;
    2. Aged over 18 years old;
    3. No history of drug or alcohol dependence, and no use of contraceptives or hormones within the past three months;
    4. Fully informed of the study, signed informed consent and volunteered to participate.

      (2)Family Caregivers

    <!-- -->

    1. Spouses, adult children or other relatives who provide long-term unpaid daily care and companionship for patients;
    2. Aged over 18 years old;
    3. No history of drug or alcohol dependence, and no use of contraceptives or hormones within the past three months;
    4. Fully informed of the study, signed informed consent and volunteered to participate.

Exclusion criteria

Exclusion Criteria:

  • (1)Patients:

    1. Patients who do not meet the surgical indications as evaluated by clinicians;
    2. Patients with immune system diseases;
    3. Patients with a history of mental illness or severe cognitive impairment.

      (2)Family Caregivers:

    <!-- -->

    1. Caregivers with severe organic lesions themselves;
    2. Caregivers who have experienced other major life events recently;
    3. Caregivers with a history of mental illness or severe cognitive impairment.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • Active comparator
    Caregiver Control Group

    Routine Care

    Behavioral: Routine health education

  • Experimental
    Caregiver Intervention Group

    Cognitive Intervention+Routine Care

    Behavioral: Caregiver cognitive intervention based on printed handbook

  • Active comparator
    Patient Control Group

    Routine Care

    Behavioral: Routine perioperative health education

  • Experimental
    Patient Intervention Group

    Caregiver Cognitive Intervention+Routine Care

    Behavioral: Graded information disclosure strategies

Interventions

  • BehavioralCaregiver cognitive intervention based on printed handbook

    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.

  • BehavioralGraded information disclosure strategies

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

  • BehavioralRoutine perioperative health education

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

  • BehavioralRoutine health education

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 1 day before operation, 1 day after operation, and 1 month after discharge

Secondary outcomes

  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.

    Time frame: 1 day before operation, 1 day after operation, and 1 month after discharge

  2. Blood Pressure

    Time frame: 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.

    Time frame: 1 day before operation, 1 day after operation, and 1 month after discharge

  4. BMI

    Time frame: 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.

    Time frame: 1 day before operation, 1 day after operation, and 1 month after discharge

07

Study locations

1 site
  • Anhui Provincial Hospital
    Hefei, Anhui, China
08

References and documents

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 ↗

Individual participant data

Plan to share: 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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07749443
Lead sponsor
Anhui Medical University
Responsible party
Dan Su (Associate Professor, Anhui Medical University) — Principal investigator
First posted
Aug 6, 2026
Start date
May 1, 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026
Last update
Aug 6, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion