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NCT06930313Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
84 (estimated)
First submitted
14 Jan 2025
Start date
1 Mar 2026
Primary completion date
31 Dec 2027
Lead sponsor
Taipei Medical University
Diseases
Lung cancer
NCT number
NCT06930313

What you commit to

  • Study type: Interventional
  • Planned participants: 84
  • From 1 Mar 2026 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently receiving psychological therapy
  • Previous experience with mindfulness or self-compassion training

Other illness

  • Diagnosed with a severe mental illness and taking medication for it (e.g.,psychosis, bipolar disorder)

Who the study is looking for

  • 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

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Taipei Medical University
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.