CancerNCT06461780
Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy
An observational study of Cancer and Immunotherapy, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
During the immune checkpoint inhibitor therapy (ICIT), most of the patients stay at home, but there is lacking of the studies to explore their physical and psychological distress, financial toxicity, care needs, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Immunotherapy, IrAE
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Mar 2024to 1 Aug 2028
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited at inpatients and outpatient clinic of department of chest medicine, department of oncology, division of gastroenterology and hepatology, and department of obsterics and gynecology.
Who may be able to join
- (1) Patients diagnose cancer and are informed
- (2) Aged ≥18 years old
- (3) Conscious clear and able to communicate
Who cannot join
None listed.
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
Taipei Veterans General Hospital
Taipei
I-Wen Chang, PHD, 886-2-2875-7193, iwchang@vghtpe.gov.tw
About this study
Official title: Exploring Physical and Psychological Distress, Financial Toxicity, Care Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy in One Year Follow-up: Psychometric Testing and Developing Prediction Models for Immune-related Adverse Events
During the immune checkpoint inhibitor therapy (ICIT), most of the patients stay at home, but there is lacking of the studies to explore their physical and psychological distress, financial toxicity, care needs, and quality of life. Therefore, the aims of this program are to (1) explore the immune-related adverse event (irAE) severity, distress, financial toxicity, and quality of life and examine the psychometric testing of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM); (2) establish the LINE group for assessing irAE severity and change trajectory of quality of life in one-year follow-up and (3) combined retrospective chart review and the finding in aim (2) to develop the risk prediction model in order to identify the high risk population.
Read the detailed description
To achieve aim 1, a cross-sectional design is conducted to explore irAE severity, distress, financial distress, and quality of life in mixed type of cancer patients receiving ICIT. A structural questionnaire will be used including Common Terminology Criteria for adverse events (CTCAE) 33 items, Distress Thermometer (DT), the Comprehensive Score for financial Toxicity (COST), FACT-ICM, and EORTC-QLQ C30. Correlation analysis and exploratory factor analysis will be used to examine the psychometric testing of FACT-ICM.
To achieve aim 2 and 3, a prospective cohort study will be conducted to recruit 200 patients in first course receiving ICIT and follow for 1 year using LINE to report symptoms in weekly reporting within 3 months and once in 3-4 weeks in 4th -12th months during treatment. Data will be collected at five times (Before treatment for baseline, the 3th, 6th 9th 12th months) using a set of questionnaires including CTCAE 33 items, DT, COST, Supportive Care Needs Scale-short form34, and FACT-ICM.
- Conditions
- Cancer, Immunotherapy, IrAE, Distress, Emotional, Care Need, Financial Toxicity
- Medical subject headings
- Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1: Cross-sectional study | A cross-sectional design is conducted to explore irAE severity, distress, financial distress, and quality of life in mixed type of cancer patients receiving ICIT. | |
| Aim 2 and 3: Longitudinal follow-up | The Line-based questionnaire follow-up app will be used to collect and follow patients' condition and syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Report Outcome-- Common Terminology Criteria for adverse events (PRO-CTCAE)
Interviewers graded the severity of adverse events according to the Common Terminology Criteria for adverse events (CTCAE), version 5, from the National Cancer Institute (NCI). In this study, we included 33 important symptoms from PRO-CTCAE in immunotherapy patients.
Measured: The data will be collected once a week within 3 months and once in 3-4 weeks in 4th-12th months during treatment.
Symptom Severity Scale (SSS)
The Symptom Severity Scale (SSS) was used to evaluate the symptom severity of cancer patients. It included 25 common symptoms in cancer patients.The severity was scored by an 11-point numerical rating scale, from 0 (not at all) to 10 (very severe).
Measured: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
Distress Thermometer (DT)
The Distress Theremometer is utilized to assess patients' emotional distress and its sources. The assessment was developed by National Comprehensive Cancer Network (NCCN) and to evaluate the psychological distress level of cancer patients. It a single-item-11-point scale, from 0 to 10 points, which ask patients about their overall distress level over the past week, with higher scores indicating higher levels of distress.
Measured: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
The COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)
The COST-FACIT developed by Souza, is used to assess patients' financial distress. It evaluates the financial situation of patients undergoing treatment for chronic diseases. The scale consists of 12 items rated on a 0 to 4 Likert-type scale, where 0 indicates "not at all important" and 4 indicates "very important." Lower scores indicate greater financial toxicity.
Measured: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
The Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM)
The FACT-ICM is used to assess the quality of life in cancer patients undergoing immunotherapy. It comprises 25 symptom-related items specific to immune checkpoint modulation therapy and 27 items from the Functional Assessment of Cancer Therapy-General (FACT-G), totaling 52 items. Ratings are done on a 0 to 4 Likert-type scale, where 0 indicates no distress at all and 4 indicates extreme distress.
Measured: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)
To assess the convergent validity of the FACT-ICM, we employed this scale to analyze the correlation between two sets of quality of life data. It consists of 30 items assessing five major functional domains in cancer patients. Ratings for most items are done on a 1 to 4 Likert-type scale, where 1 indicates no presence and 4 indicates very severe presence of symptoms, with higher scores indicating poorer quality of life.
Measured: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
Supportive Care Needs Survey-Short Form 34 (SCNS-SF34)
The SCNS-SF34 comprises 34 items and utilizes a 1 to 5 Likert-type scoring system, where 1 indicates no need and 5 indicates the greatest need for assistance. Scores for each domain, based on the total scores of individual items, are standardized to a range of 0 to 100, with higher scores indicating greater unmet needs in that domain.
Measured: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start18 Mar 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Sponsor
- Investigators
- I-Wen Chang, PHD, Study chair, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461780
- Sponsor's protocol ID
- 2023-03-005BC
- Other IDs
- NSTC 114-2314-B-A49 -008 -, NSTC 113-2314-B-A49 -013 -, NSTC 112-2314-B-A49 -077 -
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on the Institutional Review Board of the study site, the patients does not agree to give their data to other study.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Physical and Psychological Distress, Financial Toxicity, Care Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy in One Year Follow-up: Psychometric Testing and Developing Prediction Models for Immune-related Adverse Events
- ClinicalTrials.gov ID
- NCT06461780
- Acronym / sponsor ID
- 2023-03-005BC
- Conditions
- Cancer, Immunotherapy, IrAE, Distress, Emotional, Care Need, Financial Toxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 17 Jun 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.
During the immune checkpoint inhibitor therapy (ICIT), most of the patients stay at home, but there is lacking of the studies to explore their physical and psychological distress, financial toxicity, care needs, and quality of life. Therefore, the aims of this program are to (1) explore the immune-related adverse event (irAE) severity, distress, financial toxicity, and quality of life and examine the psychometric testing of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM); (2) establish the LINE group for assessing irAE severity and change trajectory of quality of life in one-year follow-up and (3) combined retrospective chart review and the finding in aim (2) to develop the risk prediction model in order to identify the high risk population.
Detailed description
To achieve aim 1, a cross-sectional design is conducted to explore irAE severity, distress, financial distress, and quality of life in mixed type of cancer patients receiving ICIT. A structural questionnaire will be used including Common Terminology Criteria for adverse events (CTCAE) 33 items, Distress Thermometer (DT), the Comprehensive Score for financial Toxicity (COST), FACT-ICM, and EORTC-QLQ C30. Correlation analysis and exploratory factor analysis will be used to examine the psychometric testing of FACT-ICM.
To achieve aim 2 and 3, a prospective cohort study will be conducted to recruit 200 patients in first course receiving ICIT and follow for 1 year using LINE to report symptoms in weekly reporting within 3 months and once in 3-4 weeks in 4th -12th months during treatment. Data will be collected at five times (Before treatment for baseline, the 3th, 6th 9th 12th months) using a set of questionnaires including CTCAE 33 items, DT, COST, Supportive Care Needs Scale-short form34, and FACT-ICM.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Cross-sectional study | – | –A cross-sectional design is conducted to explore irAE severity, distress, financial distress, and quality of life in mixed type of cancer patients receiving ICIT. |
| Aim 2 and 3: Longitudinal follow-up | – | –The Line-based questionnaire follow-up app will be used to collect and follow patients' condition and syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited at inpatients and outpatient clinic of department of chest medicine, department of oncology, division of gastroenterology and hepatology, and department of obsterics and gynecology.
Key inclusion criteria (3 listed)
- (1) Patients diagnose cancer and are informed
- (2) Aged ≥18 years old
- (3) Conscious clear and able to communicate
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient-Report Outcome-- Common Terminology Criteria for adverse events (PRO-CTCAE)
Time frame: The data will be collected once a week within 3 months and once in 3-4 weeks in 4th-12th months during treatment.
Interviewers graded the severity of adverse events according to the Common Terminology Criteria for adverse events (CTCAE), version 5, from the National Cancer Institute (NCI). In this study, we included 33 important symptoms from PRO-CTCAE in immunotherapy patients.
Symptom Severity Scale (SSS)
Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
The Symptom Severity Scale (SSS) was used to evaluate the symptom severity of cancer patients. It included 25 common symptoms in cancer patients.The severity was scored by an 11-point numerical rating scale, from 0 (not at all) to 10 (very severe).
Distress Thermometer (DT)
Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
The Distress Theremometer is utilized to assess patients' emotional distress and its sources. The assessment was developed by National Comprehensive Cancer Network (NCCN) and to evaluate the psychological distress level of cancer patients. It a single-item-11-point scale, from 0 to 10 points, which ask patients about their overall distress level over the past week, with higher scores indicating higher levels of distress.
The COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)
Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
The COST-FACIT developed by Souza, is used to assess patients' financial distress. It evaluates the financial situation of patients undergoing treatment for chronic diseases. The scale consists of 12 items rated on a 0 to 4 Likert-type scale, where 0 indicates "not at all important" and 4 indicates "very important." Lower scores indicate greater financial toxicity.
The Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM)
Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
The FACT-ICM is used to assess the quality of life in cancer patients undergoing immunotherapy. It comprises 25 symptom-related items specific to immune checkpoint modulation therapy and 27 items from the Functional Assessment of Cancer Therapy-General (FACT-G), totaling 52 items. Ratings are done on a 0 to 4 Likert-type scale, where 0 indicates no distress at all and 4 indicates extreme distress.
European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)
Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
To assess the convergent validity of the FACT-ICM, we employed this scale to analyze the correlation between two sets of quality of life data. It consists of 30 items assessing five major functional domains in cancer patients. Ratings for most items are done on a 1 to 4 Likert-type scale, where 1 indicates no presence and 4 indicates very severe presence of symptoms, with higher scores indicating poorer quality of life.
Supportive Care Needs Survey-Short Form 34 (SCNS-SF34)
Time frame: The data will be collected at five times (Before treatment for baseline, the 3rd, 6th, 9th, and 12th month)
The SCNS-SF34 comprises 34 items and utilizes a 1 to 5 Likert-type scoring system, where 1 indicates no need and 5 indicates the greatest need for assistance. Scores for each domain, based on the total scores of individual items, are standardized to a range of 0 to 100, with higher scores indicating greater unmet needs in that domain.
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 30 Apr 2026.
- Individual participant dataSharing planned: No. Based on the Institutional Review Board of the study site, the patients does not agree to give their data to other study.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
I-Wen Chang, PHD study chair
Taipei Veterans General Hospital, Taiwan
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 Cancer and Immunotherapy, run by Taipei Veterans General Hospital, Taiwan 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 0 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 30 Apr 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 I-Wen Chang, PHD (886-2-2875-7193, iwchang@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Report Outcome-- Common Terminology Criteria for adverse events (PRO-CTCAE) (time frame: The data will be collected once a week within 3 months and once in 3-4 weeks in 4th-12th months during treatment.). The study lists 7 primary outcomes in all. 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 30 Apr 2026.