Family-Supported Palliative Care in Advanced Lung Cancer

NCT07490639 | Completed

• 1 other identifier: FSPC-LC-2024-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Lung Cancer; Non-Small Cell Lung Cancer; Lung Neoplasms

Keywords

Palliative Care; Family-Supported Care; Shared Decision-Making; Quality of Life; Decisional Conflict; Hope; Psychological Intervention; Oncology Nursing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in Decisional Conflict Measured by Decisional Conflict Scale (DCS)

  Baseline to 8 weeks

• Change in Hope Level Measured by Herth Hope Index (HHI)

  Baseline to 8 weeks

• Change in Anxiety Measured by Self-Rating Anxiety Scale (SAS)

  Baseline to 8 weeks

• Change in Depression Measured by Self-Rating Depression Scale (SDS)

  Baseline to 8 weeks

• Change in Nutritional Status (Serum Albumin and Prealbumin)

  Baseline to 8 weeks

Study Arms (2)

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.

Behavioral: Family-Supported Palliative Care

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.

Behavioral: Routine Nursing Care

Interventions

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.

Family-Supported Palliative Care

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.

Routine Nursing Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanxi Province Cancer Hospital: lead

Study Sites (1)

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, 030013, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Qingjuan Li, MD

  Shanxi Province Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, Taiyuan, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: January 1, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 28, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)