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

2026年7月12日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

120

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 台湾
    • Taipei
      • Taipei、Taipei、台湾、100225
        • 募集
        • National Taiwan University Hospital
        • コンタクト：
      • Taipei、Taipei、台湾、106
        • 募集
        • National Taiwan University Cancer Center
        • コンタクト：
        • 主任研究者：
          • Yeur-Hur Lai, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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.
他の名前：
  • ICSM
他の：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.
アクティブコンパレータ：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.
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

National Taiwan University Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年4月8日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年6月1日

試験登録日

最初に提出

2026年7月12日

QC基準を満たした最初の提出物

2026年7月12日

最初の投稿 (実際)

2026年7月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月16日

QC基準を満たした最後の更新が送信されました

2026年7月12日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 202404134RINC
  • NSTC 113-2314-B-002-137 (その他の助成金/資金番号：National Science and Technology Council, Taiwan)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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