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NCT Number: NCT07708870

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Advanced Lung Cancer Behavior Behavioral Symptoms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Caregiver Burden Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Resource Utilization Respiratory Tract Diseases Respiratory Tract Neoplasms Stress, Psychological Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Cancer Center, Taipei, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrating Nurse-Led and Resource Utilization-Based Caregiver Support Model

Behavioral

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.

Other names: ICSM

Oncology Case Manager Care and Usual Care

Other

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.

Primary outcomes

  1. Change in Caregiver Quality of Life as Measured by the Caregiver Quality of Life Index-Cancer (CQOLC)

    Time frame: 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 outcomes

  1. Change in Caregiver Resource Utilization as Measured by the Resource and Utilization Assessment Scale

    Time frame: 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.

  2. Change in Caregiver Strain as Measured by the Caregiver Strain Index

    Time frame: 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.

  3. Change in Caregiver Anxiety as Measured by the Generalized Anxiety Disorder-7 Scale

    Time frame: 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.

  4. Change in Caregiver Depressive Symptoms as Measured by the Patient Health Questionnaire-9

    Time frame: 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.

  5. Change in Caregiver Sleep Quality as Measured by the Pittsburgh Sleep Quality Index

    Time frame: 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.

  6. Change in Patient Quality of Life and Lung Cancer-Related Symptoms as Measured by the EORTC QLQ-C30 and EORTC QLQ-LC13

    Time frame: 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.

  7. Change in Patient Supportive Care Needs as Measured by the Supportive Care Needs Survey-Screening Tool Chinese Version

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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)

Acronym: ICSM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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