Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer (ICSM)
12. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
120
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Taipei
-
Taipei, Taipei, Taiwan, 100225
- Rekrutierung
- National Taiwan University Hospital
-
Kontakt:
- Yeur-Hur Lai, PhD
- Telefonnummer: 288429 +886-2-2312-3456
- E-Mail: laiyhwk@ntu.edu.tw
-
Taipei, Taipei, Taiwan, 106
- Rekrutierung
- National Taiwan University Cancer Center
-
Kontakt:
- Yeur-Hur Lai, PhD
- Telefonnummer: 288429 +886-2-2312-3456
- E-Mail: laiyhwk@ntu.edu.tw
-
Hauptermittler:
- Yeur-Hur Lai, PhD
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
Andere Namen:
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.
|
|
Aktiver 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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale
Zeitfenster: 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
|
|
Change in Caregiver Strain as Measured by the Caregiver Strain Index
Zeitfenster: 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.
|
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
Zeitfenster: 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.
|
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
Zeitfenster: 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.
|
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
Zeitfenster: 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.
|
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
|
Change in Patient Quality of Life and Lung Cancer-Related Symptoms as Measured by the EORTC QLQ-C30 and EORTC QLQ-LC13
Zeitfenster: 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.
|
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
|
Change in Patient Supportive Care Needs as Measured by the Supportive Care Needs Survey-Screening Tool Chinese Version
Zeitfenster: 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.
|
Baseline, 2 weeks, 1 month, 3 months, 6 months, and 12 months after the first treatment
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
8. April 2025
Primärer Abschluss (Geschätzt)
1. Juni 2027
Studienabschluss (Geschätzt)
1. Juni 2027
Studienanmeldedaten
Zuerst eingereicht
12. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Juli 2026
Zuerst gepostet (Tatsächlich)
16. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
16. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 202404134RINC
- NSTC 113-2314-B-002-137 (Andere Zuschuss-/Finanzierungsnummer: National Science and Technology Council, Taiwan)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .