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Non-Small Cell Lung CancerICSMNCT07708870

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

A study testing Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model in people with Non-Small Cell Lung Cancer and Advanced Lung Cancer, run by National Taiwan University Hospital at 2 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesTaiwan
Study dates
8 Apr 2025to Jun 2027
Phase
Interventional
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

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan2 sites, 2 recruiting

  • National Taiwan University Hospital

    Taipei, Taipei, 100225

    Yeur-Hur Lai, PhD, +886-2-2312-3456 ext. 288429, laiyhwk@ntu.edu.tw

    Recruiting

  • National Taiwan University Cancer Center

    Taipei, Taipei, 106

    Yeur-Hur Lai, PhD, +886-2-2312-3456 ext. 288429, laiyhwk@ntu.edu.tw

    Yeur-Hur Lai, PhD

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model, Oncology Case Manager Care and Usual Care
Keywords
Older Adults, Family Caregivers, Nurse-Led Intervention, Resource Utilization, Oncology Case Management, Web-Based Platform, LINE-Based Platform, Supportive Care, Psychological Distress, Quality of Life
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrating Nurse-Led and Resource Utilization-Based Caregiver Support ModelBehavioural

    Also called ICSM

    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.

  • Oncology Case Manager Care and Usual CareOther

    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.

Study groups in NCT07708870
Study groupRoleWhat they receive
ICSM Plus Oncology Case Manager CareExperimentalParticipants 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.
Receives: Behavioral: Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model; Other: Oncology Case Manager Care and Usual Care
Oncology Case Manager Care and Usual CareActive comparatorParticipants 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.
Receives: Other: Oncology Case Manager Care and Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)

    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.

    Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment

Secondary outcomes (7)

  1. Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale

    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.

    Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment

  2. Change in Caregiver Strain as Measured by the Caregiver Strain Index

    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.

    Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment

  3. Change in Caregiver Anxiety as Measured by the Generalized Anxiety Disorder-7 Scale

    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.

    Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment

  4. Change in Caregiver Depressive Symptoms as Measured by the Patient Health Questionnaire-9

    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.

    Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment

  5. Change in Caregiver Sleep Quality as Measured by the Pittsburgh Sleep Quality Index

    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.

    Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment

  6. Change in Patient Quality of Life and Lung Cancer-Related Symptoms as Measured by the EORTC QLQ-C30 and EORTC QLQ-LC13

    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.

    Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment

  7. Change in Patient Supportive Care Needs as Measured by the Supportive Care Needs Survey-Screening Tool Chinese Version

    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.

    Measured: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start8 Apr 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Eligible patient-caregiver dyads are 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.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07708870
Sponsor's protocol ID
202404134RINC
Other IDs
NSTC 113-2314-B-002-137
Acronym
ICSM
Status last verified
Jul 2026
First submitted
12 Jul 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model in people with Non-Small Cell Lung Cancer and Advanced Lung Cancer, run by National Taiwan University Hospital at 2 sites 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 12 inclusion and 5 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 16 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 2 sites 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07708870.

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 16 Jul 2026.

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