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Completed

NCT Number: NCT07490639

Family-Supported Palliative Care in Advanced Lung Cancer

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.

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Key information

Conditions

Advanced Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, 030013, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Quality of Life Measured by Functional Assessment of Cancer Therapy-Lung (FACT-L)

    Time frame: 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 outcomes

  1. Change in Decisional Conflict Measured by Decisional Conflict Scale (DCS)

    Time frame: 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.

  2. Change in Hope Level Measured by Herth Hope Index (HHI)

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. Change in Nutritional Status (Serum Albumin and Prealbumin)

    Time frame: 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.

  6. Change in Pain- and Inflammation-Related Biomarkers (SP, PGE2, DA, CRP)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanxi Province Cancer Hospital

Other

Registry information

Official study title

Study on the Impact of Family-Supported Palliative Care on Decision-Making Experience, Mental Attitude, and Quality of Life in Patients With Advanced Lung Cancer

Acronym: FSPC-LC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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