Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer
ICSM
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)
2 other identifiers
interventional
120
1 country
2
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable nonsmall-cell-lung-cancer
Started Apr 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 8, 2025
CompletedFirst Submitted
Initial submission to the registry
July 12, 2026
CompletedFirst Posted
Study publicly available on registry
July 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
July 16, 2026
July 1, 2026
2.1 years
July 12, 2026
July 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
Secondary Outcomes (7)
Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale
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
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
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
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
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
- +2 more secondary outcomes
Study Arms (2)
ICSM Plus Oncology Case Manager Care
EXPERIMENTALParticipants 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.
Oncology Case Manager Care and Usual Care
ACTIVE 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- \- Severe cognitive impairment that prevents completion of study questionnaires or assessments.
- Unable to communicate sufficiently to complete study assessments.
- Unable or unwilling to provide written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Taiwan University Hospital
Taipei, Taipei, 100225, Taiwan
National Taiwan University Cancer Center
Taipei, Taipei, 106, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking is used because participants and intervention providers are aware of the assigned supportive care intervention.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2026
First Posted
July 16, 2026
Study Start
April 8, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
July 16, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
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.