Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer (ICSM)

July 12, 2026 updated by: National Taiwan University Hospital

Expanding Caregiving Capacities for Caregivers of Older Adults With Newly Diagnosed Advanced Lung Cancer: A Study of Current Status and Evaluation of the Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model (ICSM)

This two-phase study aims to examine the current status of older adults with newly diagnosed locally advanced or advanced non-small cell lung cancer and their primary family caregivers, and to evaluate the effects of the Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model (ICSM). Phase I is a cross-sectional correlational study assessing distress, unmet care needs, resource awareness and utilization, social support, and health promotion practice. Phase II is a two-group randomized controlled trial comparing ICSM plus oncology case manager care with oncology case manager care and usual hospital care. The intervention includes nurse-led education and counseling, symptom management, emotional coping, problem-solving, social resource use, caregiving activity arrangement, and use of a web-based or LINE-based integrated resource system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is designed as a two-phase, three-year study. Phase I is a cross-sectional correlational study conducted to examine physical and psychological distress, daily function, unmet care needs, knowledge and utilization of resources, social support, and health promotion practice among older adults with locally advanced or advanced non-small cell lung cancer and their primary family caregivers.

Phase II is a two-group, 12-month randomized controlled trial. Eligible patient-caregiver dyads will be randomized to either an experimental group receiving the Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model (ICSM) plus oncology case manager care, or a control group receiving oncology case manager care and usual hospital care. The ICSM intervention includes nurse-led education and counseling and use of an information and resource platform designed to support lung cancer care, caregiver self-care, distress management, and health promotion.

The main intervention components include understanding non-small cell lung cancer treatment recommendations, symptom detection and management, care of aging-related problems, coping with emotional distress, problem-solving and social resource use, maintaining social function during caregiving, relaxation skills, and use of information and resources related to cancer care, long-term care, and caregiver support. Outcomes will be assessed at baseline and at follow-up time points after the first treatment. Generalized estimating equations will be used to examine intervention effects over time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
    • Taipei
      • Taipei, Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taipei, Taiwan, 106
        • Recruiting
        • National Taiwan University Cancer Center
        • Contact:
        • Principal Investigator:
          • Yeur-Hur Lai, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patient inclusion criteria:

  • Older adults with newly diagnosed locally advanced or advanced non-small cell lung cancer.
  • Stage III or stage IV non-small cell lung cancer.
  • Aware of their cancer diagnosis.
  • Preparing to receive anti-cancer medical treatment.
  • Able to communicate verbally and complete study assessments.
  • Willing to participate in the study and provide written informed consent.

Caregiver inclusion criteria:

  • Adult aged 18 years or older.
  • Identified by the eligible patient as the fixed primary family caregiver.
  • Able to participate in the study together with the patient as a patient-caregiver dyad.
  • Willing to participate in the study and provide written informed consent.

Exclusion Criteria:

Patient exclusion criteria:

- Severe cognitive impairment that prevents completion of study questionnaires or assessments.

Caregiver exclusion criteria:

  • Unable to communicate sufficiently to complete study assessments.
  • Unable or unwilling to provide written informed consent.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ICSM Plus Oncology Case Manager Care
Participants in this group receive the Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model (ICSM) in addition to oncology case manager care and usual hospital care. The intervention includes nurse-led education and counseling, symptom management, emotional coping, problem-solving, social resource use, caregiving activity arrangement, and use of a web-based or LINE-based integrated resource system.
Behavioral: Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model
The ICSM is a nurse-led supportive care intervention designed for older adults with advanced non-small cell lung cancer and their primary family caregivers. It includes structured education and counseling, symptom detection and management, care of aging-related problems, coping with emotional distress, problem-solving, social resource utilization, maintenance of social function during caregiving, and use of an integrated web-based or mobile messaging-based resource platform.
Other Names:
  • ICSM
Other: Oncology Case Manager Care and Usual Care
Participants receive routine oncology case manager care and usual hospital care according to standard clinical practice. This may include routine cancer care, standard follow-up, clinical consultation, and support provided through the hospital's usual care process.
Active Comparator: Oncology Case Manager Care and Usual Care
Participants in this group receive oncology case manager care and usual hospital care. This includes routine cancer care, standard follow-up, and support provided through the hospital's usual care process.
Other: Oncology Case Manager Care and Usual Care
Participants receive routine oncology case manager care and usual hospital care according to standard clinical practice. This may include routine cancer care, standard follow-up, clinical consultation, and support provided through the hospital's usual care process.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
Time Frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Caregiver quality of life will be assessed using the Caregiver Quality of Life Index-Cancer (CQOLC). The CQOLC is a 35-item instrument using a 5-point Likert-type scale from 0 to 4 to assess quality of life among family caregivers of patients with cancer, including physical, emotional, family, and social functioning. The total score ranges from 0 to 140, with higher scores indicating better caregiver quality of life after reverse scoring of negatively worded items.
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale
Time Frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Caregiver resource utilization will be assessed using the Resource and Utilization Assessment Scale. The scale evaluates caregivers' awareness and use of health-related, social, community, and professional resources. Higher scores indicate greater resource awareness and utilization.
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Change in Caregiver Strain as Measured by the Caregiver Strain Index
Time Frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Caregiver strain will be assessed using the Caregiver Strain Index (CSI). The CSI is a 13-item instrument that measures perceived and reported strain among caregivers across employment, financial, social, physical, and time-related domains. Higher scores indicate greater caregiver strain.
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Change in Caregiver Anxiety as Measured by the Generalized Anxiety Disorder-7 Scale
Time Frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Caregiver anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. The GAD-7 includes 7 items scored from 0 to 3, with a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptoms.
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Change in Caregiver Depressive Symptoms as Measured by the Patient Health Questionnaire-9
Time Frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Caregiver depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 includes 9 items scored from 0 to 3, with a total score ranging from 0 to 27. Higher scores indicate greater depressive symptom severity.
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Change in Caregiver Sleep Quality as Measured by the Pittsburgh Sleep Quality Index
Time Frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Caregiver sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Change in Patient Quality of Life and Lung Cancer-Related Symptoms as Measured by the EORTC QLQ-C30 and EORTC QLQ-LC13
Time Frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Patient quality of life and lung cancer-related symptoms will be assessed using the EORTC QLQ-C30 and EORTC QLQ-LC13. Scores are transformed to a 0 to 100 scale. Higher scores on global health and functional scales indicate better functioning or quality of life, whereas higher scores on symptom scales indicate greater symptom burden.
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Change in Patient Supportive Care Needs as Measured by the Supportive Care Needs Survey-Screening Tool Chinese Version
Time Frame: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Patient supportive care needs will be assessed using the Supportive Care Needs Survey-Screening Tool Chinese Version (SCNS-ST9-C) and study-specific additional items. Higher scores indicate greater unmet supportive care needs.
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202404134RINC
  • NSTC 113-2314-B-002-137 (Other Grant/Funding Number: National Science and Technology Council, Taiwan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because this study collects sensitive health-related and psychosocial information from older adults with advanced lung cancer and their family caregivers. Data access and use will be limited to the approved study team and the purposes specified in the IRB-approved protocol and informed consent documents. Aggregate results may be reported in publications, presentations, or study reports.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings