Compassion-Based Intervention for Lung Cancer Caregivers (CBI-LCC)
NCT ID: NCT06930313
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
84 participants
INTERVENTIONAL
2026-03-01
2028-02-28
Brief Summary
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Method: In the first year, the intervention will be developed in three stages. Initially, the intervention will be created based on compassion-focused theory and evidence-based exercises, incorporating feedback from family caregivers in previous studies and insights from professionals to ensure its relevance to lung cancer caregivers. Next, a pilot study will test the intervention's feasibility and acceptability with 30 family caregivers, using mixed methods to gather session-by-session feedback and assess recruitment, retention, and adherence. Following the pilot, the intervention will be revised based on participant and researcher feedback, preparing it for further study. In the second and third years, a randomized controlled trial (RCT) will be conducted with 84 participants randomly assigned to either the 4-session Brief Compassion-Based Intervention (BCI) or a single-session Telephone-Based Support and Education (TSE) control group. Outcomes, including depression, anxiety, caregiver stress, mindfulness, self-compassion, and self-efficacy, will be measured at baseline, immediately post-intervention, and at 3- and 6-month follow-ups. For data analysis, long-term follow-up quantitative data will be analyzed using the Generalized Estimating Equation (GEE) to examine group differences. Moderation and mediation analyses will be conducted to explore potential moderators and mechanisms of the intervention. Qualitative data from interviews will be analyzed using content analysis.
Expected Results: This study is expected to provide a comprehensive understanding of the feasibility, acceptability, and effectiveness of compassion-based interventions for lung cancer caregivers, contributing to their application in clinical care practice.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Arm 2: Control Arm Name: Telephone-Based Support and Education (TSE) Description: Participants in this arm will receive a single-session Telephone-Based Support and Education (TSE), providing general caregiving advice and emotional support.
SUPPORTIVE_CARE
DOUBLE
Investigator Masking: Investigators responsible for data collection and analysis will be blinded to group allocation to maintain objectivity.
Study Groups
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Brief Compassion-Based Intervention (BCI)
Participants in this arm will receive a 4-session Brief Compassion-Based Intervention (BCI) focused on managing depression and anxiety in family caregivers of lung cancer patients.
Brief Compassion-Based Intervention (BCI)
The intervention program is based on Compassion-Focused Therapy (CFT) and incorporates evidence-based compassion exercises.Drawing on insights from the literature, the program includes:Session 1: Introduction to caregiving challenges and emotional systems. Includes a soothing breathing exercise and group discussion on caregiving stress.
Session 2: Cultivating self-compassion. Includes reflecting on emotions, guided meditation, and a compassionate body scan practice.
Session 3: Transforming self-criticism into self-compassion. Caregivers explore self-critical thoughts, practice reframing, and engage in compassionate dialogue.
Session 4: Building resilience and connections. Focuses on gratitude, setting boundaries, and loving-kindness meditation, ending with daily intention setting.
Telephone-Based Support and Education (TSE)
Participants in this arm will receive a single-session Telephone-Based Support and Education (TSE), providing general caregiving advice and emotional support.
Telephone-Based Support and Education (TSE)
The session will address their questions and concerns, provide psychological support for managing difficult emotions (e.g., anxiety, fear, sadness, and guilt), and emphasize the importance of self-care, encouraging them to take time for themselves and seek support when needed.
Interventions
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Brief Compassion-Based Intervention (BCI)
The intervention program is based on Compassion-Focused Therapy (CFT) and incorporates evidence-based compassion exercises.Drawing on insights from the literature, the program includes:Session 1: Introduction to caregiving challenges and emotional systems. Includes a soothing breathing exercise and group discussion on caregiving stress.
Session 2: Cultivating self-compassion. Includes reflecting on emotions, guided meditation, and a compassionate body scan practice.
Session 3: Transforming self-criticism into self-compassion. Caregivers explore self-critical thoughts, practice reframing, and engage in compassionate dialogue.
Session 4: Building resilience and connections. Focuses on gratitude, setting boundaries, and loving-kindness meditation, ending with daily intention setting.
Telephone-Based Support and Education (TSE)
The session will address their questions and concerns, provide psychological support for managing difficult emotions (e.g., anxiety, fear, sadness, and guilt), and emphasize the importance of self-care, encouraging them to take time for themselves and seek support when needed.
Eligibility Criteria
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Inclusion Criteria
* Aged 20 years or older
* Access to a computer or smartphone with internet connection at home
Exclusion Criteria
* Diagnosed with a severe mental illness and taking medication for it (e.g.,psychosis, bipolar disorder)
* Previous experience with mindfulness or self-compassion training
20 Years
ALL
No
Sponsors
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National Science and Technology Council
FED
Taipei Medical University
OTHER
Responsible Party
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Locations
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Taipei Medical University
Taipei, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB Approval Number
Identifier Type: OTHER
Identifier Source: secondary_id
N202411055
Identifier Type: -
Identifier Source: org_study_id
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