Compassion-Based Intervention for Lung Cancer Caregivers (CBI-LCC)

Not Applicable

Not yet recruiting

• Conditions: Compassion

• Registration Number: NCT06930313
• Lead Sponsor: Taipei Medical University

Brief Summary

Objectives: This 3-year study aims to develop, refine, and evaluate a brief compassion-based intervention specifically designed for family caregivers of lung cancer patients. In the first year, the primary focus will be on developing the intervention content and assessing its feasibility and acceptability. In the second and third years, the goal will be to assess the intervention's effects on depression and anxiety.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Study Start: 2026-03-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Primary family caregiver of a person with newly diagnosed lung cancer (within one year of diagnosis)
• Aged 20 years or older
• Access to a computer or smartphone with internet connection at home

Exclusion Criteria

• Currently receiving psychological therapy
• Diagnosed with a severe mental illness and taking medication for it (e.g.,psychosis, bipolar disorder)
• Previous experience with mindfulness or self-compassion training

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS) Questionnaire	From baseline through study completion, up to 6 months.	Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), a validated self-report questionnaire developed by Zigmond and Snaith in 1983. The HADS comprises 14 items divided into two subscales: anxiety (7 items) and depression (7 items). Participants will rate the frequency of symptoms experienced during the past week on a 4-point Likert scale ranging from 0 ("not at all") to 3 ("most of the time"). Scores on each subscale range from 0 to 21, with higher scores indicating greater levels of anxiety or depression.

Secondary Outcome Measures

Name	Time	Method
Kingston Caregiver Stress Scale (KCSS) Questionnaire	From baseline through study completion, up to 6 months.	Caregiving-related stress will be assessed using the Kingston Caregiver Stress Scale (KCSS), a validated self-report questionnaire developed by Sadak et al. (2017). The KCSS includes 10 items measuring caregivers' perceived stress across three domains: caregiving duties (7 items), family-related pressures (2 items), and financial challenges (1 item). Items are rated on a 5-point Likert scale ranging from 1 ("feeling fine/no stress") to 5 ("extreme stress"). Total scores range from 10 to 50, with higher scores indicating greater levels of caregiving stress.
Five Facet Mindfulness Questionnaire (FFMQ-15)	From baseline through study completion, up to 6 months.	Mindfulness will be assessed using the 15-item Five Facet Mindfulness Questionnaire (FFMQ-15), a validated self-report questionnaire that evaluates five facets of mindfulness: observing, describing, acting with awareness, non-judgment, and non-reactivity. Participants rate their agreement with each item on a 5-point Likert scale ranging from 1 ("rarely true") to 5 ("always true"). Scores from each item are summed to produce a total mindfulness score ranging from 15 to 75, with higher scores indicating greater mindfulness.
Self-Compassion Scale (SCS) Questionnaire	From baseline through study completion, up to 6 months.	Self-compassion will be assessed using the Self-Compassion Scale, a validated 13-item self-report questionnaire developed by Gilbert et al. (2017). This measure evaluates an individual's capacity for self-compassion across two subscales. Participants rate each item on a 10-point Likert scale ranging from 1 ("Never") to 10 ("Always"). The two subscale scores are summed to produce a total score, with higher scores indicating greater self-compassion.
General Self-Efficacy Scale (GSES) Questionnaire	From baseline through study completion, up to 6 months.	Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES), a validated 10-item self-report questionnaire developed by Schwarzer and Jerusalem (1995). The GSES evaluates an individual's perception of their capability to manage daily challenges and cope effectively with stressful life events. Participants rate each item on a 4-point Likert scale ranging from 1 ("not at all") to 4 ("exactly true"). Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan