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Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer (ICSM)

sunnuntai 12. heinäkuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

120

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Taiwan
    • Taipei
      • Taipei, Taipei, Taiwan, 100225
        • Rekrytointi
        • National Taiwan University Hospital
        • Ottaa yhteyttä:
          • Yeur-Hur Lai, PhD
          • Puhelinnumero: 288429 +886-2-2312-3456
          • Sähköposti: laiyhwk@ntu.edu.tw
      • Taipei, Taipei, Taiwan, 106
        • Rekrytointi
        • National Taiwan University Cancer Center
        • Ottaa yhteyttä:
          • Yeur-Hur Lai, PhD
          • Puhelinnumero: 288429 +886-2-2312-3456
          • Sähköposti: laiyhwk@ntu.edu.tw
        • Päätutkija:
          • Yeur-Hur Lai, PhD

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Tukevaa hoitoa
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Käyttäytyminen: Integrating 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.
Muut nimet:
  • ICSM
Muut: Oncology 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.
Active Comparator: 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.
Muut: Oncology 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

National Taiwan University Hospital

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Sunnuntai 12. heinäkuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Sunnuntai 12. heinäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Torstai 16. heinäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 16. heinäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Sunnuntai 12. heinäkuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. heinäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 202404134RINC
  • NSTC 113-2314-B-002-137 (Muu apuraha/rahoitusnumero: National Science and Technology Council, Taiwan)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

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.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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