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

NCT07749443 | Completed DMC

• 2 other identifiers: 832434432023AH050616
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

• Anxiety and Depression(HADS)

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

• Blood Pressure

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

• Resilience(CD-RISC)

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

• BMI

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

• Lymphocyte count

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

Study Arms (4)

Caregiver Control Group

ACTIVE COMPARATOR

Routine Care

Behavioral: Routine health education

Caregiver Intervention Group

EXPERIMENTAL

Cognitive Intervention+Routine Care

Behavioral: Caregiver cognitive intervention based on printed handbook

Patient Control Group

ACTIVE COMPARATOR

Routine Care

Behavioral: Routine perioperative health education

Patient Intervention Group

EXPERIMENTAL

Caregiver Cognitive Intervention+Routine Care

Behavioral: Graded information disclosure strategies

Interventions

Caregiver cognitive intervention based on printed handbook BEHAVIORAL

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.

Caregiver Intervention Group

Graded information disclosure strategies BEHAVIORAL

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

Patient Intervention Group

Routine perioperative health education BEHAVIORAL

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

Patient Control Group

Routine health education BEHAVIORAL

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

Caregiver Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, China

Location

Related Publications (1)

• 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.

  PMID: 34975555 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 6, 2026
• Study Start: May 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: August 6, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)