Lung Cancer (NSCLC)
Conditions
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.
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.
Sponsors
Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
* (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict（DCS） | 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. |
| Functional status(FACT-L) | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and Depression(HADS) | 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. |
| 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 | 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. |
| 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 | Lymphocyte count is tested by routine peripheral venous blood analysis, unit: ×10⁹/L. |
Countries
China
Outcome results
None listed