Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer (ICSM)
12 lipca 2026 zaktualizowane przez: National Taiwan University Hospital
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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
120
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Taipei
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Taipei, Taipei, Tajwan, 100225
- Rekrutacyjny
- National Taiwan University Hospital
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Kontakt:
- Yeur-Hur Lai, PhD
- Numer telefonu: 288429 +886-2-2312-3456
- E-mail: laiyhwk@ntu.edu.tw
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Taipei, Taipei, Tajwan, 106
- Rekrutacyjny
- National Taiwan University Cancer Center
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Kontakt:
- Yeur-Hur Lai, PhD
- Numer telefonu: 288429 +886-2-2312-3456
- E-mail: laiyhwk@ntu.edu.tw
-
Główny śledczy:
- Yeur-Hur Lai, PhD
-
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: ICSM Plus Oncology Case Manager Care
Participants 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.
|
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.
Inne nazwy:
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.
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Aktywny komparator: Oncology Case Manager Care and Usual Care
Participants 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
Ramy czasowe: 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.
|
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale
Ramy czasowe: 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.
|
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
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Change in Caregiver Strain as Measured by the Caregiver Strain Index
Ramy czasowe: 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.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Change in Caregiver Anxiety as Measured by the Generalized Anxiety Disorder-7 Scale
Ramy czasowe: 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.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
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Change in Caregiver Depressive Symptoms as Measured by the Patient Health Questionnaire-9
Ramy czasowe: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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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.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Change in Caregiver Sleep Quality as Measured by the Pittsburgh Sleep Quality Index
Ramy czasowe: 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.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
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Change in Patient Quality of Life and Lung Cancer-Related Symptoms as Measured by the EORTC QLQ-C30 and EORTC QLQ-LC13
Ramy czasowe: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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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.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Change in Patient Supportive Care Needs as Measured by the Supportive Care Needs Survey-Screening Tool Chinese Version
Ramy czasowe: Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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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.
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Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
8 kwietnia 2025
Zakończenie podstawowe (Szacowany)
1 czerwca 2027
Ukończenie studiów (Szacowany)
1 czerwca 2027
Daty rejestracji na studia
Pierwszy przesłany
12 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
12 lipca 2026
Pierwszy wysłany (Rzeczywisty)
16 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
16 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
12 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 202404134RINC
- NSTC 113-2314-B-002-137 (Inny numer grantu/finansowania: National Science and Technology Council, Taiwan)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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