Advanced Lung Cancer, Caregiver Burden, Non-Small Cell Lung Cancer, Resource Utilization
Conditions
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
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.
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.
Interventions
BEHAVIORALIntegrating 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.
OTHEROncology 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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
No masking is used because participants and intervention providers are aware of the assigned supportive care intervention.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| Change in Patient Quality of Life and Lung Cancer-Related Symptoms as Measured by the EORTC QLQ-C30 and EORTC QLQ-LC13 | 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. |
| Change in Patient Supportive Care Needs as Measured by the Supportive Care Needs Survey-Screening Tool Chinese Version | 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. |
Countries
Taiwan
Outcome results
None listed