Clinical trial NCT06930313: Compassion-Based Intervention for Lung Cancer Caregivers (CBI-LCC)
Official title: Development and Evaluation of a Brief Compassion-Based Intervention for Managing Depression and Anxiety in Family Caregivers of Lung Cancer Patients: A Mixed Methods Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Compassion
Keywords: compassion-based intervention
lung cancer
family caregivers
caregiver stress
depression
anxiety
mindfulness
self-compassion
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2025-04-16
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Experimental Arm Name: Brief Compassion-Based Intervention (BCI) Description: 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.

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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS) Questionnaire
timeFrame: From baseline through study completion, up to 6 months.
Secondary outcomes:
measure: Kingston Caregiver Stress Scale (KCSS) Questionnaire
timeFrame: From baseline through study completion, up to 6 months.
measure: Five Facet Mindfulness Questionnaire (FFMQ-15)
timeFrame: From baseline through study completion, up to 6 months.
measure: Self-Compassion Scale (SCS) Questionnaire
timeFrame: From baseline through study completion, up to 6 months.
measure: General Self-Efficacy Scale (GSES) Questionnaire
timeFrame: From baseline through study completion, up to 6 months.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
References: