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

March 18, 2026 updated by: Shanxi Province Cancer Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Province Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family-Supported Palliative Care
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
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.
Active Comparator: Routine Nursing Care
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks
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.
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanxi Province Cancer Hospital

Investigators

  • Principal Investigator: Qingjuan Li, MD, Shanxi Province Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, Taiyuan, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

February 20, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSPC-LC-2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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