Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer (NCT07708870) | Clinical Trial Compass
RecruitingNot Applicable
Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer
Taiwan120 participantsStarted 2025-04-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
Timeframe: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment