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Completed

NCT Number: NCT07749443

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anhui Provincial Hospital

Hefei, Anhui, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Treatment and study plan

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.

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.

Routine Perioperative Health Education

Behavioral

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

routine health education

Behavioral

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

Primary outcomes

  1. Decisional Conflict(DCS)

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

    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.

  2. Functional status(FACT-L)

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

    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.

Secondary outcomes

  1. Anxiety and Depression(HADS)

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

    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.

  2. Blood Pressure

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

  3. Resilience(CD-RISC)

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

    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.

  4. BMI

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

  5. Lymphocyte count

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

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

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Acronym: FST

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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