Advanced Lung CancerFSPC-LCNCT07490639
Family-Supported Palliative Care in Advanced Lung Cancer
A study testing Family-Supported Palliative Care and Routine Nursing Care in people with Advanced Lung Cancer and Non-Small Cell Lung Cancer, run by Shanxi Province Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Cancer, Non-Small Cell Lung Cancer, Lung Neoplasms
- What is being tested?
- Family-Supported Palliative Care and Routine Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Being tested
- Family-Supported Palliative Care, Routine Nursing Care
- Keywords
- Palliative Care, Family-Supported Care, Shared Decision-Making, Quality of Life, Decisional Conflict, Hope, Psychological Intervention, Oncology Nursing
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Supported Palliative CareBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Routine Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks
Secondary outcomes (6)
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.
Measured: Baseline to 8 weeks
Change in Hope Level Measured by Herth Hope Index (HHI)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Jan 2024
- Primary completion20 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanxi Province Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qingjuan Li, MD, Principal investigator, Shanxi Province Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, Taiyuan, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490639
- Sponsor's protocol ID
- FSPC-LC-2024-01
- Acronym
- FSPC-LC
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07490639
- Acronym / sponsor ID
- FSPC-LC / FSPC-LC-2024-01
- Keywords
- Palliative Care, Family-Supported Care, Shared Decision-Making, Quality of Life, Decisional Conflict, Hope, Psychological Intervention, Oncology Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Shanxi Province Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Family-Supported Palliative Care | Experimental | Behavioral: Family-Supported Palliative CareParticipants 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 | Behavioral: Routine Nursing CareParticipants received routine oncology nursing care, including standard health education, daily care support, and basic psychological counseling, without structured family-supported palliative care intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-Supported Palliative CareA 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. | Behavioural | Family-Supported Palliative Care |
| Routine Nursing CareStandard 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. | Behavioural | Routine Nursing Care |
Primary outcome
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.
6 secondary outcomes
Change in Decisional Conflict Measured by Decisional Conflict Scale (DCS)
Time frame: Baseline to 8 weeks
Change in Hope Level Measured by Herth Hope Index (HHI)
Time frame: Baseline to 8 weeks
Change in Anxiety Measured by Self-Rating Anxiety Scale (SAS)
Time frame: Baseline to 8 weeks
Change in Depression Measured by Self-Rating Depression Scale (SDS)
Time frame: Baseline to 8 weeks
Change in Nutritional Status (Serum Albumin and Prealbumin)
Time frame: Baseline to 8 weeks
Change in Pain- and Inflammation-Related Biomarkers (SP, PGE2, DA, CRP)
Time frame: Baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Advanced Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingjuan Li, MD principal investigator
Shanxi Province Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, Taiyuan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Supported Palliative Care and Routine Nursing Care in people with Advanced Lung Cancer and Non-Small Cell Lung Cancer, run by Shanxi Province Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life Measured by Functional Assessment of Cancer Therapy-Lung (FACT-L) (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.