Clinical trial NCT04869267: Acceptance and Commitment Therapy in Patients With Advanced Lung Cancer
Official title: Effectiveness of Acceptance and Commitment Therapy on Fatigue Interference and Health-related Quality of Life Among Patients With Advanced Lung Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Advanced Cancer
Keywords: lung cancer
palliative care
Acceptance and Commitment Therapy
fatigue
health-related quality of life
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 160
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 based on usual care. Participants in Group B receive usual care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lung cancer is a malignant tumor 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 stage. Cancer related fatigue is the most common and distressing symptom reported by lung cancer patients. For cancer patients, fatigue has lasting impact on physical, psychological and social functions, interferes with activities and participating in life events, thereby worsening the health-related quality of life. Acceptance and Commitment Therapy (ACT) is the third-wave cognitive behavioral therapy to improve functioning and health-related quality of life by increasing psychological flexibility. The study aims to examine the effectiveness of ACT on fatigue interference and health-related quality of life in patients with advanced lung cancer.

Detailed description: A two-arm, assessor-blind randomized controlled trial will be conducted to investigate the effects of ACT on advanced lung cancer patients compared to usual care. Participants in the same ward will be randomized 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 size of 4, 6 to avoid selection bias. The study aims to examine the effectiveness of ACT on fatigue interference and health-related quality of life in patients with advanced lung cancer. The Specific objectives are: 1) To investigate the effects of ACT on primary outcomes: fatigue interference and health-related quality of life compared to control group at post-intervention and three months follow-up. 2) To investigate the effects of ACT on the secondary outcomes: cancer-related fatigue, depressive symptoms, anxiety, distress and exercise capacity and process outcomes including psychological flexibility, ACT related variables (acceptance and cognitive defusion) at post-intervention and three months follow-up.

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. experienced unexplained fatigue syndrome: the score of 3 or more on the Fatigue Symptom Inventory (FSI); and
4. able to provide informed consent and effectively collect data.

Exclusion Criteria:

1. diagnosed with cognitive dysfunction or other mental illnesses that may interfere with their completion of treatment;
2. who are with a life expectancy \<3 months, or whose physical conditions are considered ineligible for the present study based on the physician's judgment; and
3. who are receiving or have just completed other lung cancer-related intervention programs within the last six months

Primary outcomes:
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 4-week intervention)
measure: Change from baseline in the score of the score of fatigue interference assessed by The Fatigue Symptom Inventory at three months after the 4-week intervention
timeFrame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
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 4-week intervention)
measure: Change from baseline in the score of health-related quality of life assessed by Functional Assessment of Cancer Therapy - Lung, Version 4 at three months after the 4-week intervention
timeFrame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Secondary outcomes:
measure: Change from baseline in the score of cancer related fatigue assessed by The Multidimensional Fatigue Inventory at one week after the intervention
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
measure: Change from baseline in the score of cancer related fatigue assessed by The Multidimensional Fatigue Inventory at three months after the intervention
timeFrame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
measure: Change from baseline in the score of depressive symptoms assessed by The Patient Health Questionnaire (PHQ-9) at one week after the intervention.
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
measure: Change from baseline in the score of depressive symptoms assessed by The Patient Health Questionnaire (PHQ-9) at three months after the intervention.
timeFrame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
measure: Change from baseline in the score of anxiety assessed by Generalized Anxiety Disorder Scale (GAD-7) at one week after the intervention.
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
measure: Change from baseline in the score of anxiety assessed by Generalized Anxiety Disorder Scale (GAD-7) at three months after the intervention.
timeFrame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
measure: Change from baseline in the score of psychological distress assessed by Impact of Events Scale -Revised version at one week after the intervention.
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
measure: Change from baseline in the score of psychological distress assessed by Impact of Events Scale -Revised version at three months after the intervention.
timeFrame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
measure: Change from baseline in exercise capacity assessed by self-designed questions at one week after the intervention
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
measure: Change from baseline in exercise capacity assessed by self-designed questions at three months after the intervention
timeFrame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
measure: Change from baseline in the score of psychological flexibility assessed by Comprehensive assessment of Acceptance and Commitment Therapy processes at one week after the intervention
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 4-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 three months follow-up (T2, three months after the 4-week intervention)
measure: Change from baseline in the score of acceptance assessed by Acceptance and Action Cancer Questionnaire at one week after the intervention
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
measure: Change from baseline in the score of acceptance assessed by Acceptance and Action Cancer Questionnaire at three months after the intervention
timeFrame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
measure: Change from baseline in the score of cognitive fusion assessed by Cognitive Fusion Questionnaire at one week after the intervention
timeFrame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
measure: Change from baseline in the score of cognitive fusion assessed by Cognitive Fusion Questionnaire at three months after the intervention
timeFrame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
affiliation: Chinese University of Hong Kong
name: Huiyuan LI
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Cho Lee Wong, PhD
role: STUDY_DIRECTOR
References: