Lung Cancer, Immunotherapy, Quality of Life, Symptom Severity, Care NeedsNCT06433206
Care Needs in Lung Cancer Patients Receiving Immunotherapy
An observational study of Lung Cancer, Immunotherapy, Quality of Life, Symptom Severity, Care Needs, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Lung cancer ranks as the leading cause of cancer-related deaths globally and is among the most common malignancies. In recent years, the advancements in immune checkpoint inhibitors have marked a significant breakthrough in the immunotherapy of lung cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer, Immunotherapy, Quality of Life, Symptom Severity, Care Needs
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Apr 2021to 31 Dec 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Using consecutive sampling, lung cancer patients who have received or are currently undergoing immunotherapy will be selected from a medical center and a specialized cancer hospital in northern Taiwan.
Who may be able to join
- Individuals diagnosed with malignant lung tumors based on imaging or post-surgical histopathological examination results by specialized physicians.
- Individuals who have received immunotherapy in the past or are currently undergoing immunotherapy.
- Research participants who are conscious, aged 20 years or older, able to communicate in Mandarin or Taiwanese, capable of completing the questionnaire, willing to participate in the study, and have signed the research consent form.
Who cannot join
- Individuals with significant cognitive impairments who are unable to complete the questionnaire.
- Individuals who are unable to communicate in Mandarin or Taiwanese.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Cancer Center
Taipei, Taiwan, 106
Meng Ping Hsiao, Master, +886 919865349, A00708@ntucc.gov.tw
About this study
Official title: Quality of Life, Symptom Severity, and Care Needs in Lung Cancer Patients Receiving Immunotherapy
Lung cancer ranks as the leading cause of cancer-related deaths globally and is among the most common malignancies. In recent years, the advancements in immune checkpoint inhibitors have marked a significant breakthrough in the immunotherapy of lung cancer. However, immunotherapy is a relatively new treatment modality, and ongoing clinical trials continue to explore its efficacy. Due to a lack of knowledge about immunotherapy-related care, patients often experience uncertainty and anxiety regarding its effectiveness, resulting in associated care needs.
A total of 160 lung cancer patients were included in the study. The research findings revealed statistically significant correlations (p < 0.05) between the severity of disease, symptomatology, overall health status, functional capacity, cognitive function, disease progression, mood, and general supportive care needs, as well as specific needs of lung cancer patients.
Regarding factors influencing care needs, it was found that general supportive care needs were significantly influenced by marital status, average personal monthly income, and disease progression. Additionally, age, surgical history, functional capacity, and cognitive function significantly influenced specific care needs. Based on these statistical findings, it is crucial for nursing staff to closely monitor changes in patients' symptoms and mood and provide timely care and support. Furthermore, future interventions should focus on addressing the heightened needs of lung cancer patients, thereby reducing their dissatisfaction along the cancer treatment journey.
Read the detailed description
Background and Purpose: Lung cancer is a major health concern affecting the Taiwanese population. Immunotherapy represents a novel treatment approach which activates the immune system to combat tumor cells through a series of interactions. However, the side effects associated with immunotherapy can be significant, potentially causing uncertainty and anxiety in patients. Medical decision-making also involves numerous considerations, impacting their psychosocial well-being and subsequent health behaviors. Research in this area remains limited. Therefore, this study aims to (1) explore the quality of life, severity of symptoms, and care needs of lung cancer patients following immunotherapy; (2) investigate the correlations between quality of life, severity of symptoms, and care needs; and (3) identify predictive factors for the care needs of immunotherapy patients.
Research Method: This study adopts a cross-sectional research design, conducted at a medical center and a specialized cancer hospital in Taipei City. Recruitment takes place in hospital wards, treatment rooms, and outpatient clinics, utilizing consecutive sampling. Lung cancer patients who have undergone or are currently undergoing immunotherapy are selected. Structured questionnaires are employed, covering demographics, disease treatment characteristics, severity of symptoms, quality of life, functional disability, supportive care needs, fear of disease progression, and qualitative interviews. Quantitative data are analyzed using descriptive and inferential statistics in SPSS version 22.0. The study aims to enroll 180 participants.
Expected Results: The anticipated findings of this study are expected to provide valuable insights for clinical healthcare professionals. They can aid in understanding patients' needs, contribute to the development of post-immunotherapy care guidelines for lung cancer patients, and serve as essential references for healthcare reimbursement policies. These outcomes may help alleviate patient burden and enhance quality of life. It is expected that demographic characteristics, disease treatment characteristics, quality of life, severity of symptoms, and the extent of care needs will be positively correlated and serve as important predictors of care needs.
- Being tested
- no intervention
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Care Needs in Lung Cancer Patients Receiving Immunotherapy
Measured: 1year
Secondary outcomes (2)
Quality of Life in Lung Cancer Patients Receiving Immunotherapy
Measured: 1year
Symptom Severity in Lung Cancer Patients Receiving Immunotherapy
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start21 Apr 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Immunotherapy, Quality of Life, Symptom Severity, Care NeedsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Ping Hsiao, master, Principal investigator, NTUCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433206
- Sponsor's protocol ID
- 201911078RIND
- Status last verified
- Jul 2026
- First submitted
- 22 May 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life, Symptom Severity, and Care Needs in Lung Cancer Patients Receiving Immunotherapy
- ClinicalTrials.gov ID
- NCT06433206
- Acronym / sponsor ID
- 201911078RIND
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 May 2024 (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.
Lung cancer ranks as the leading cause of cancer-related deaths globally and is among the most common malignancies. In recent years, the advancements in immune checkpoint inhibitors have marked a significant breakthrough in the immunotherapy of lung cancer. However, immunotherapy is a relatively new treatment modality, and ongoing clinical trials continue to explore its efficacy. Due to a lack of knowledge about immunotherapy-related care, patients often experience uncertainty and anxiety regarding its effectiveness, resulting in associated care needs.
A total of 160 lung cancer patients were included in the study. The research findings revealed statistically significant correlations (p < 0.05) between the severity of disease, symptomatology, overall health status, functional capacity, cognitive function, disease progression, mood, and general supportive care needs, as well as specific needs of lung cancer patients.
Regarding factors influencing care needs, it was found that general supportive care needs were significantly influenced by marital status, average personal monthly income, and disease progression. Additionally, age, surgical history, functional capacity, and cognitive function significantly influenced specific care needs. Based on these statistical findings, it is crucial for nursing staff to closely monitor changes in patients' symptoms and mood and provide timely care and support. Furthermore, future interventions should focus on addressing the heightened needs of lung cancer patients, thereby reducing their dissatisfaction along the cancer treatment journey.
Detailed description
Background and Purpose: Lung cancer is a major health concern affecting the Taiwanese population. Immunotherapy represents a novel treatment approach which activates the immune system to combat tumor cells through a series of interactions. However, the side effects associated with immunotherapy can be significant, potentially causing uncertainty and anxiety in patients. Medical decision-making also involves numerous considerations, impacting their psychosocial well-being and subsequent health behaviors. Research in this area remains limited. Therefore, this study aims to (1) explore the quality of life, severity of symptoms, and care needs of lung cancer patients following immunotherapy; (2) investigate the correlations between quality of life, severity of symptoms, and care needs; and (3) identify predictive factors for the care needs of immunotherapy patients.
Research Method: This study adopts a cross-sectional research design, conducted at a medical center and a specialized cancer hospital in Taipei City. Recruitment takes place in hospital wards, treatment rooms, and outpatient clinics, utilizing consecutive sampling. Lung cancer patients who have undergone or are currently undergoing immunotherapy are selected. Structured questionnaires are employed, covering demographics, disease treatment characteristics, severity of symptoms, quality of life, functional disability, supportive care needs, fear of disease progression, and qualitative interviews. Quantitative data are analyzed using descriptive and inferential statistics in SPSS version 22.0. The study aims to enroll 180 participants.
Expected Results: The anticipated findings of this study are expected to provide valuable insights for clinical healthcare professionals. They can aid in understanding patients' needs, contribute to the development of post-immunotherapy care guidelines for lung cancer patients, and serve as essential references for healthcare reimbursement policies. These outcomes may help alleviate patient burden and enhance quality of life. It is expected that demographic characteristics, disease treatment characteristics, quality of life, severity of symptoms, and the extent of care needs will be positively correlated and serve as important predictors of care needs.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Using consecutive sampling, lung cancer patients who have received or are currently undergoing immunotherapy will be selected from a medical center and a specialized cancer hospital in northern Taiwan.
Key inclusion criteria (3 listed)
- Individuals diagnosed with malignant lung tumors based on imaging or post-surgical histopathological examination results by specialized physicians.
- Individuals who have received immunotherapy in the past or are currently undergoing immunotherapy.
- Research participants who are conscious, aged 20 years or older, able to communicate in Mandarin or Taiwanese, capable of completing the questionnaire, willing to participate in the study, and have signed the research consent form.
Key exclusion criteria (2 listed)
- Individuals with significant cognitive impairments who are unable to complete the questionnaire.
- Individuals who are unable to communicate in Mandarin or Taiwanese.
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Care Needs in Lung Cancer Patients Receiving Immunotherapy
Time frame: 1year
2 secondary outcomes
Quality of Life in Lung Cancer Patients Receiving Immunotherapy
Time frame: 1year
Symptom Severity in Lung Cancer Patients Receiving Immunotherapy
Time frame: 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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.
Meng Ping Hsiao, master principal investigator
NTUCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Immunotherapy, Quality of Life, Symptom Severity, Care Needs, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 31 Jul 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Ping Hsiao, master (+886 919865349, A00708@ntucc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care Needs in Lung Cancer Patients Receiving Immunotherapy (time frame: 1year). 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 31 Jul 2026.