CompassionCBI-LCCNCT06930313
Compassion-Based Intervention for Lung Cancer Caregivers (CBI-LCC)
A study testing Brief Compassion-Based Intervention (BCI) and Telephone-Based Support and Education (TSE) in people with Compassion, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Compassion
- What is being tested?
- Brief Compassion-Based Intervention (BCI) and Telephone-Based Support and Education (TSE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University
Taipei, Taiwan, 11031
Chia-Chen Taipei Medical University, +886-2-2736-1661 ext. 27737, chiachenh@tmu.edu.tw
About this study
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
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
- Being tested
- Brief Compassion-Based Intervention (BCI), Telephone-Based Support and Education (TSE)
- Keywords
- compassion-based intervention, lung cancer, family caregivers, caregiver stress, depression, anxiety, mindfulness, self-compassion
- Medical subject headings
- Lung Neoplasms, Caregiver Burden, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Compassion-Based Intervention (BCI)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Telephone-Based Support and Education (TSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline through study completion, up to 6 months.
Secondary outcomes (4)
Kingston Caregiver Stress Scale (KCSS) Questionnaire
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.
Measured: From baseline through study completion, up to 6 months.
Five Facet Mindfulness Questionnaire (FFMQ-15)
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.
Measured: From baseline through study completion, up to 6 months.
Self-Compassion Scale (SCS) Questionnaire
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.
Measured: From baseline through study completion, up to 6 months.
General Self-Efficacy Scale (GSES) Questionnaire
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.
Measured: From baseline through study completion, up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CompassionStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930313
- Sponsor's protocol ID
- N202411055
- Other IDs
- IRB Approval Number
- Acronym
- CBI-LCC
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06930313
- Acronym / sponsor ID
- CBI-LCC / N202411055
- Conditions
- Compassion
- Keywords
- compassion-based intervention, lung cancer, family caregivers, caregiver stress, depression, anxiety, mindfulness, self-compassion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brief Compassion-Based Intervention (BCI) | Experimental | Behavioral: 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. |
| Telephone-Based Support and Education (TSE) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Brief Compassion-Based Intervention (BCI) |
| 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. | Behavioural | Telephone-Based Support and Education (TSE) |
Primary outcome
Hospital Anxiety and Depression Scale (HADS) Questionnaire
Time frame: 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.
4 secondary outcomes
Kingston Caregiver Stress Scale (KCSS) Questionnaire
Time frame: From baseline through study completion, up to 6 months.
Five Facet Mindfulness Questionnaire (FFMQ-15)
Time frame: From baseline through study completion, up to 6 months.
Self-Compassion Scale (SCS) Questionnaire
Time frame: From baseline through study completion, up to 6 months.
General Self-Efficacy Scale (GSES) Questionnaire
Time frame: From baseline through study completion, up to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Compassion-Based Intervention (BCI) and Telephone-Based Support and Education (TSE) in people with Compassion, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia-Chen Hsieh, PhD (+886 2 2736 1661 ext. 6306, chiachenh@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) Questionnaire (time frame: From baseline through study completion, up to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.