Advanced Lung Cancer, Non-Small Cell Lung Cancer, Lung Neoplasms
Conditions
Keywords
Palliative Care, Family-Supported Care, Shared Decision-Making, Quality of Life, Decisional Conflict, Hope, Psychological Intervention, Oncology Nursing
Brief summary
This study aims to evaluate the clinical effectiveness and ethical implications of a family-supported palliative care model in patients with advanced lung cancer. A single-center, parallel-group randomized controlled trial was conducted, in which 110 eligible patients were randomly assigned to either a routine nursing care group or a family-supported palliative care group for an 8-week intervention period. The intervention integrates structured family involvement, palliative care education, shared decision-making support, psychological counseling, symptom management, and nutritional guidance. The primary outcome is quality of life assessed by the Functional Assessment of Cancer Therapy-Lung (FACT-L). Secondary outcomes include decisional conflict (DCS), hope level (HHI), anxiety and depression (SAS/SDS), nutritional indicators (albumin and prealbumin), and pain- and inflammation-related biomarkers (substance P, prostaglandin E2, dopamine, and C-reactive protein). This study seeks to determine whether structured family engagement can improve patient-centered outcomes, reduce decisional conflict, enhance psychological well-being, and support ethically sound shared decision-making in the context of advanced cancer care.
Detailed description
This study was designed as a single-center, parallel-group randomized controlled trial to investigate the effects of a structured family-supported palliative care intervention on decision-making experience, psychological status, and quality of life in patients with advanced lung cancer. A total of 110 patients with pathologically or cytologically confirmed advanced lung cancer were enrolled and randomly assigned in a 1:1 ratio to either the control group or the intervention group. The control group received routine oncology nursing care, while the intervention group received an integrated family-supported palliative care program in addition to routine care. The intervention lasted for 8 weeks. The family-supported palliative care model consisted of multiple components, including structured palliative care education for patients and family members, guided shared decision-making discussions, emotional support and companionship, therapeutic recreational activities, continuous communication and follow-up support, individualized pain management, and nutritional support. Family members were actively involved in the care process to enhance communication, emotional support, and decision-making alignment. Outcome measures were assessed at baseline and at the end of the 8-week intervention. The primary outcome was quality of life measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L). Secondary outcomes included decisional conflict measured by the Decisional Conflict Scale (DCS), hope level assessed using the Herth Hope Index (HHI), psychological status evaluated by the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), nutritional indicators including serum albumin and prealbumin, and pain- and inflammation-related biomarkers such as substance P, prostaglandin E2, dopamine, and C-reactive protein. This study also explores the ethical implications of family participation in end-of-life care, particularly in balancing patient autonomy with family involvement. By integrating structured family engagement into clinical practice, the study aims to provide evidence for improving patient-centered care and optimizing shared decision-making in advanced cancer management.
Interventions
BEHAVIORALFamily-Supported Palliative Care
A structured, multi-component palliative care intervention integrating active family participation. The program included palliative care education, caregiver training, shared decision-making support, emotional and social support, therapeutic activities, individualized pain management, and nutritional support, delivered over an 8-week period.
BEHAVIORALRoutine Nursing Care
Standard oncology nursing care including general health education, assistance with activities of daily living, and routine psychological support, without additional structured family-supported palliative care intervention.
Sponsors
Shanxi Province Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants were randomly assigned in a 1:1 ratio to either the intervention group (family-supported palliative care plus routine nursing) or the control group (routine nursing care alone) and followed for 8 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically or cytologically confirmed diagnosis of advanced lung cancer (stage III-IV or limited prognosis). * Age ≥ 18 years. * Receiving initial or first-line systemic treatment. * Fully informed of the diagnosis, with normal cognitive function and ability to communicate effectively. * Able to complete questionnaires and assessments. * Provided written informed consent.
Exclusion criteria
* Prior exposure to more than one line of systemic antitumor therapy. * Severe cognitive impairment or diagnosed psychiatric disorders affecting compliance. * Severe comorbid conditions (cardiac, hepatic, or renal dysfunction) with life expectancy \< 3 months. * Conditions that may interfere with outcome assessment, such as active infection or systemic inflammatory diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Measured by Functional Assessment of Cancer Therapy-Lung (FACT-L) | Baseline to 8 weeks | Quality of life was assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. The outcome was defined as the change in total FACT-L score from baseline to the end of the 8-week intervention period. Higher scores indicate better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Decisional Conflict Measured by Decisional Conflict Scale (DCS) | Baseline to 8 weeks | Decisional conflict was assessed using the Decisional Conflict Scale (DCS). The outcome was defined as the change in total DCS score from baseline to 8 weeks. Lower scores indicate less decisional conflict. |
| Change in Hope Level Measured by Herth Hope Index (HHI) | Baseline to 8 weeks | Hope level was assessed using the Herth Hope Index (HHI). The outcome was defined as the change in total HHI score from baseline to 8 weeks. Higher scores indicate higher levels of hope. |
| Change in Anxiety Measured by Self-Rating Anxiety Scale (SAS) | Baseline to 8 weeks | Anxiety was assessed using the Self-Rating Anxiety Scale (SAS). The outcome was defined as the change in standardized SAS score from baseline to 8 weeks. Higher scores indicate more severe anxiety symptoms. |
| Change in Depression Measured by Self-Rating Depression Scale (SDS) | Baseline to 8 weeks | Depression was assessed using the Self-Rating Depression Scale (SDS). The outcome was defined as the change in standardized SDS score from baseline to 8 weeks. Higher scores indicate more severe depressive symptoms. |
| Change in Nutritional Status (Serum Albumin and Prealbumin) | Baseline to 8 weeks | Nutritional status was assessed by serum albumin and prealbumin levels. The outcome was defined as the change in these indicators from baseline to 8 weeks. |
| Change in Pain- and Inflammation-Related Biomarkers (SP, PGE2, DA, CRP) | Baseline to 8 weeks | Pain- and inflammation-related biomarkers including substance P (SP), prostaglandin E2 (PGE2), dopamine (DA), and C-reactive protein (CRP) were measured. The outcome was defined as the change in these biomarkers from baseline to 8 weeks. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORQingjuan Li, MD
Shanxi Province Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, Taiyuan, China
Outcome results
None listed