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

NCT06930313 | Not Yet Recruiting

• 2 other identifiers: N202411055IRB Approval Number
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Compassion

Keywords

compassion-based intervention; lung cancer; family caregivers; caregiver stress; depression; anxiety; mindfulness; self-compassion

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale (HADS) Questionnaire

  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.

  From baseline through study completion, up to 6 months.

Secondary Outcomes (4)

• Kingston Caregiver Stress Scale (KCSS) Questionnaire

  From baseline through study completion, up to 6 months.

• Five Facet Mindfulness Questionnaire (FFMQ-15)

  From baseline through study completion, up to 6 months.

• Self-Compassion Scale (SCS) Questionnaire

  From baseline through study completion, up to 6 months.

• General Self-Efficacy Scale (GSES) Questionnaire

  From baseline through study completion, up to 6 months.

Study Arms (2)

Brief Compassion-Based Intervention (BCI)

EXPERIMENTAL

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.

Behavioral: Brief Compassion-Based Intervention (BCI)

Telephone-Based Support and Education (TSE)

ACTIVE COMPARATOR

Participants in this arm will receive a single-session Telephone-Based Support and Education (TSE), providing general caregiving advice and emotional support.

Behavioral: Telephone-Based Support and Education (TSE)

Interventions

Brief Compassion-Based Intervention (BCI) BEHAVIORAL

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.

Brief Compassion-Based Intervention (BCI)

Telephone-Based Support and Education (TSE) BEHAVIORAL

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.

Telephone-Based Support and Education (TSE)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead
• National Science and Technology Council: collaborator

Study Sites (1)

Taipei Medical University

Taipei, Taiwan, 11031, Taiwan

Location

MeSH Terms

Conditions

Lung Neoplasms; Caregiver Burden; Depression; Anxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Chia-Chen Hsieh, PhD

CONTACT

+886 2 2736 1661; chiachenh@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant Masking Description: Participants will not be informed of their group allocation (Intervention or Control group). While participants will know the specific type of support they are receiving (e.g., Compassion-Based Intervention or Telephone-Based Support), they will not be aware of which group is considered the experimental intervention. Investigator Masking: Investigators responsible for data collection and analysis will be blinded to group allocation to maintain objectivity.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: April 16, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: April 16, 2025

Record last verified: 2025-01

Locations

TW (1)