Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Unable to communicate sufficiently to complete study assessments.
Unable or unwilling to provide written informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model
BehavioralThe 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 Care
Other interventionParticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: ICSM Plus Oncology Case Manager CareExperimental treatment 2 interventions
Group B: Oncology Case Manager Care and Usual CareActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatmentSecondary outcomes
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.
Time frame
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment2
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.
Time frame
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment3
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.
Time frame
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment4
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.
Time frame
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatmentLocations
2Map coordinates are unavailable for these locations. Locations are shown below instead.
National Taiwan University Cancer CenterRecruiting106, Taipei, Taipei
Taiwan
TaiwanNational Taiwan University HospitalRecruiting100225, Taipei, TaipeiTaiwan
TaiwanSponsors and contacts
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Source ClinicalTrials.gov