Acceptance and Commitment Therapy on Fatigue Interference in Patients With Advanced Lung Cancer and Caregiver Burden (ACT)

Lung Cancer Clinical Trial

Official title:

Effects of Acceptance and Commitment Therapy on Fatigue Interference in Patients With Advanced Lung Cancer and Caregiver Burden: A Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05885984
• Other study ID #: CREC Ref. No. 2023.030
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: January 2024

Study information

• Verified date: May 2023
• Source: Chinese University of Hong Kong
• Contact: Huiyuan LI, PhD
• Phone: 52665977
• Email: huiyuanli[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lung cancer is a malignant tumour that has transformed from a single cancer disease into one of the most striking global health problems. Lung cancer has an insidious onset, and most patients are first diagnosed with the middle and advanced stages. Cancer-related fatigue is the most common and distressing symptom reported by lung cancer patients. For cancer patients, fatigue has a lasting impact on physical, psychological and social functions, and interferes with activities and participating in life events, thereby worsening the health-related quality of life. Family members have a key role in providing advanced lung cancer patients with informational, instrumental, and emotional support, which is crucial to patients' adaptation to the advanced illness and living a meaningful cancer life. Acceptance and Commitment Therapy (ACT) is the third-wave cognitive behavioural therapy to improve functioning and health-related quality of life by increasing psychological flexibility. The study aims to examine test the feasibility and acceptability, and preliminary effects of online ACT on fatigue interference in patients with advanced lung cancer and caregiver burden.

Description:

A two-arm, assessor-blind randomised controlled trial will be conducted to investigate the effects of ACT on advanced lung cancer patients and caregivers compared to educational control. Participants in the same ward will be randomised at a 1:1 ratio to the intervention group or control group. Block randomization will be conducted by an independent research assistant using randomly varying block sizes of 4 and 6 to avoid selection bias. The study aims to examine the feasibility and acceptability, and preliminary effects of online ACT on fatigue interference in patients with advanced lung cancer and caregiver burden. The Specific objectives are: 1. To investigate the feasibility and acceptability of the online 6-week ACT in patients with advanced lung cancer and caregivers in rural areas in China; 2. To investigate the preliminary effects of the online 6-week ACT in patients with advanced lung cancer and caregivers in rural areas in China; 3. To explore how patients and caregivers perceive the ACT experience during the intervention process.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. aged 18 or over;

2. diagnosed with stage III or stage IV lung cancer by pathological section or cytology;

3. lived in rural areas;

4. experienced unexplained fatigue syndrome: the score of 3 or more on the Fatigue Symptom Inventory (FSI);

5. able to provide informed consent and effectively collect data;

6. a consenting primary family caregiver; and

7. working phone service

Exclusion Criteria:

1. diagnosed with cognitive dysfunction or other mental illnesses that may interfere with their completion of treatment;

2. who are at critical condition; and

3. who are receiving or have just completed other lung cancer-related intervention programs within the last six months

Related Conditions & MeSH terms

• Advanced Cancer
• Caregiver Burden
• Fatigue
• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Acceptance and Commitment Therapy (ACT) plus health education
Session 1: Reviewing experiences on struggles with CRF, realising consequence of controlling, introducing acceptance as an alternative, adopting virtual mindfulness. Education (patient): epidemiologic features of advanced lung cancer. Session 2: Separate thoughts/feelings related to CRF. Education (patient): treatments and symptoms of advanced lung cancer. Session 3: Reviewing caregiver's experiences of struggling with caregiving burden,introducing acceptance as an alternative. Education (caregiver): epidemiologic features of advanced lung cancer. Session 4: Separate caregivers' thoughts/feelings related to caregiving burden. Education (caregiver): treatments and symptoms of advanced lung cancer. Session 5:Understand the importance of values and clarifying personal values for dyads. Education (dyads): eating suggestions. Session 6: Emphasise ongoing value-based goals and commitment to actions for a meaningful cancer life for dyads. Education (dyads): exercising suggestions.

Other:
• Health education
Session 1: health education on the epidemiologic features of advanced lung cancer will be taught to patients. Session 2: health education on treatments and related symptoms of advanced lung cancer will be taught to patients. Session 3: health education on the epidemiologic features of advanced lung cancer will be taught to caregivers. Session 4: health education on treatments and related symptoms of advanced lung cancer will be taught to caregivers. Session 5: health education on eating suggestions for advanced lung cancer patients and caregivers will be taught. Session 6: health education on exercising suggestions for advanced lung cancer patients and caregivers will be taught.

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Association for contextual behavioral science

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of the intervention	A convenience sample of 10 dyads in the intervention group will be recruited for focus group interviews to explore their ACT experience and overall satisfaction. The interview guide was developed based on the previous studies.	After the 6-week intervention
Primary	Eligibility rate	The eligiblity rate is defined as the percentage of participants fulfilling the inclusion criteria amongst the participants screened for the eligibility	Before baseline
Primary	Recruimtment rate	The recruitment rate is defined as the percentage of participants who consented to participate in the study amongst the participants eligible for the study	Before baseline
Primary	Attrition rate	The attrition rate is defined as the percentage of participants who withdrew from the study before completion	After the 6-week intervention
Primary	Adherence rate	The adherence rate is defined as the frequency of the practice of mindfulness and session attendance	After the 6-week intervention
Primary	Change from baseline in the score of fatigue interference assessed by The Fatigue Symptom Inventory at one week after the intervention	A 13-item instrument that measures the intensity and interference of fatigue over the previous 7 days. The first four items are used to assess the intensity of fatigue, Item 5 - Item 11 are to assess the degree to which fatigue in the past week was judged to interfere with different aspects, such as general activity, bathe and dress ability, work activity, concentration ability, relation with others, enjoyment of life and mood, using a 11-point Likert scale ranging from 0 (no interference) to 10 (extreme interference). 0 indicates no fatigue and 127 indicates the worst fatigue intensity and interference.	Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
Primary	Change from baseline in the score of caregiver burden assessed by The Zarit Caregiver Burden Inventory at one week after the intervention	12 items score from 1(not always) to 5 (always) to assess caregiver burdens of caregivers of advanced lung cancer patients, including three domains: role strain, self-criticism, and negative emotion. The overall score can be obtained by adding all subscale scores. 12 indicates low caregiver burden and 60 indicates the highest caregiver burden.	Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
Secondary	Change from baseline in the score of health-related quality of life assessed by Functional Assessment of Cancer Therapy - Lung, Version 4 at one week after the intervention	36 items scored from 0 (not at all) to 4 (very much) to assess QoL of lung cancer patients, including 5 domains: physical, social/family, emotional, and functional well-being, and additional concerns about lung cancer. The overall score can be obtained by adding all subscale scores. 0 indicates no quality of life and 144 indicates the highest quality of life.; Change= (One week after the intervention score - Baseline score)	Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
Secondary	Change from baseline in the score of meanfing of life assessed by The Meaning of Life questionnaire (MLQ) at one week after the intervention	8 items score from 0 (not at all) to 7 (totall agree) to assess meaning of life of caregivers of advanced lung cancer patients, including 2 domains: the Presence of Meaning subscale and the Search for Meaning subscale. The overall score can be obtained by adding all subscale scores. 0 indicates no meaning of life and 56 indicates the highest meaning of life.	Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
Secondary	Change from baseline in the score of psychological flexibility assessed by Comprehensive assessment of Acceptance and Commitment Therapy processes at three months after the intervention	A comprehensive ACT process measure to evaluate the level of psychological flexibility (and constituent sub-process) within the ACT model with 18 items ranged from 18 to 90. 18 indicates low level of psychological flexibility and 90 indicates the high level of psychological flexibility.	Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
Secondary	Change from baseline in the score of mindful attention assessed by Mindful Attention Awareness Scale at one week after the intervention	The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, scored from 1 (almost never) to 6 (almost always). 15 indicates low level of awareness and attention to present moment and 90 indicates the high level of awareness and attention to the present moment.	Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)