Clinical trial NCT05885984: Acceptance and Commitment Therapy on Fatigue Interference in Patients With Advanced Lung Cancer and Caregiver Burden (ACT)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Advanced Cancer
Caregiver Burden
Keywords: lung cancer
palliative care
Acceptance and Commitment Therapy
cancer-related fatigue
caregiver burden
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Association for contextual behavioral science
First posted: 2023-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to two groups in parallel for the duration of the study. Participants in Group A receive Acceptance and Commitment Therapy in addition to health education. Participants in Group B receive health education.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Eligibility rate
timeFrame: Before baseline
measure: Recruimtment rate
timeFrame: Before baseline
measure: Attrition rate
timeFrame: After the 6-week intervention
measure: Adherence rate
timeFrame: After the 6-week intervention
measure: Change from baseline in the score of fatigue interference assessed by The Fatigue Symptom Inventory at one week after the intervention
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
measure: Change from baseline in the score of caregiver burden assessed by The Zarit Caregiver Burden Inventory at one week after the intervention
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
Secondary outcomes:
measure: 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
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
measure: Change from baseline in the score of meanfing of life assessed by The Meaning of Life questionnaire (MLQ) at one week after the intervention
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
measure: 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
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
measure: Change from baseline in the score of mindful attention assessed by Mindful Attention Awareness Scale at one week after the intervention
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 6-week intervention)
Other outcomes:
measure: Acceptability of the intervention
timeFrame: After the 6-week intervention
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
affiliation: The Nethersole School of Nursing, Chinese University of Hong Kong
name: Cho Lee WONG, PhD
role: STUDY_DIRECTOR
affiliation: The Nethersole School of Nursing, Chinese University of Hong Kong
name: Huiyuan LI, PhD
role: PRINCIPAL_INVESTIGATOR
References: