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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family-Supported Palliative Care | Experimental | Participants received a structured family-supported palliative care program in addition to routine oncology nursing care for 8 weeks. The intervention included palliative care education, family caregiver training, shared decision-making discussions, emotional support, therapeutic activities, symptom management, and nutritional guidance. |
|
| Routine Nursing Care | Active Comparator | Participants received routine oncology nursing care, including standard health education, daily care support, and basic psychological counseling, without structured family-supported palliative care intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-Supported Palliative Care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Measured by Functional Assessment of Cancer Therapy-Lung (FACT-L) | 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. | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Decisional Conflict Measured by Decisional Conflict Scale (DCS) | 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. | Baseline to 8 weeks |
| Change in Hope Level Measured by Herth Hope Index (HHI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qingjuan Li, MD | Shanxi Province Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, Taiyuan, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanxi Province Cancer Hospital | Taiyuan | Shanxi | 030013 | China |
Individual participant data (IPD) will not be shared due to privacy and ethical restrictions. The data are not publicly available but available from the corresponding author upon reasonable request.
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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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.
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| Routine Nursing Care | Behavioral | 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. |
|
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. |
| Baseline to 8 weeks |
| Change in Anxiety Measured by Self-Rating Anxiety Scale (SAS) | 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. | Baseline to 8 weeks |
| Change in Depression Measured by Self-Rating Depression Scale (SDS) | 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. | Baseline to 8 weeks |
| Change in Nutritional Status (Serum Albumin and Prealbumin) | 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. | Baseline to 8 weeks |
| Change in Pain- and Inflammation-Related Biomarkers (SP, PGE2, DA, CRP) | 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. | Baseline to 8 weeks |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |