Family-Supported Palliative Care in Advanced Lung Cancer (FSPC-LC)

Shanxi Province Cancer Hospital

Status: Completed

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

Treatments: Behavioral: Family-Supported Palliative Care; Behavioral: Routine Nursing Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07490639

FSPC-LC-2024-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Family-Supported Palliative Care

Experimental group

Description:

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.

Treatment:

Behavioral: Family-Supported Palliative Care

Routine Nursing Care

Active Comparator group

Description:

Participants received routine oncology nursing care, including standard health education, daily care support, and basic psychological counseling, without structured family-supported palliative care intervention.

Treatment:

Behavioral: Routine Nursing Care