Lung CancerACTNCT04869267
Acceptance and Commitment Therapy in Patients With Advanced Lung Cancer
A study testing Acceptance and Commitment Therapy (ACT) in people with Lung Cancer and Advanced Cancer, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Advanced Cancer
- What is being tested?
- Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 7 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or over;
- diagnosed with stage III or stage IV lung cancer by pathological section or cytology;
- experienced unexplained fatigue syndrome: the score of 3 or more on the Fatigue Symptom Inventory (FSI); and
- able to provide informed consent and effectively collect data.
Who cannot join
- diagnosed with cognitive dysfunction or other mental illnesses that may interfere with their completion of treatment;
- 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
- who are receiving or have just completed other lung cancer-related intervention programs within the last six months
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Lung Cancer, Advanced Cancer
- Being tested
- Acceptance and Commitment Therapy (ACT), Usual care
- Keywords
- lung cancer, palliative care, Acceptance and Commitment Therapy, fatigue, health-related quality of life
- Medical subject headings
- Lung Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
Session 1:
This session aims to let the participants get familiar with the interventionist. The interventionist will tell them the purpose of the program and basic rules. And the interventionist will promise their privacy protection.
Session 2:
This session includes how to separate thoughts/feelings/sensations related to diagnose with advanced lung cancer and experience of fatigue with facts and see these feelings in an objective way with observing self.
Session 3:
This session mainly aims to help participants understand the importance of values, differentiate values from goals and clarify their personal values.
Session 4:
This session aims at helping patients practice to engaging in committed action based on chosen values, motivated to change behavior in consistency with life direction and health goal.
Usual careOther
The usual care mainly includes treatments and daily care during admission, medication instructions, diet and exercise advice, retest recommendations when discharge
| Study group | Role | What they receive |
|---|---|---|
| ACT group | Experimental | Participants in the intervention group will receive ACT intervention, consisting of four individual sessions (First session by face to face, the last three sessions by Wechat) of 60-90 min each (once/week), in addition to usual care. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
| Usual care group | Other | Participants randomized to the control group will receive usual care, including treatments and daily care during admission, medication instructions, diet and exercise advice, retest recommendations when discharge. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Change= (One week after the intervention score - Baseline score)
Measured: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
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
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.
Change= (Three months after the intervention score - Baseline score)
Measured: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
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)
Measured: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
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
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= (Three months after the intervention score - Baseline score)
Measured: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Secondary outcomes (16)
Change from baseline in the score of cancer related fatigue assessed by The Multidimensional Fatigue Inventory at one week after the intervention
20-item self-reported instrument testing the subjective experience of fatigue. 20 indicates the low level of fatigue and 80 indicates the high level of fatigue. 20 indicates low level of fatigue and 80 indicates the high level of fatigue.
Change= (One week after the intervention score - Baseline score)
Measured: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of cancer related fatigue assessed by The Multidimensional Fatigue Inventory at three months after the intervention
20-item self-reported instrument testing the subjective experience of fatigue. 20 indicates the low level of fatigue and 80 indicates the high level of fatigue. 20 indicates low level of fatigue and 80 indicates the high level of fatigue.
Change= (Three months after the intervention score - Baseline score)
Measured: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in the score of depressive symptoms assessed by The Patient Health Questionnaire (PHQ-9) at one week after the intervention.
A 9-item scale to measure the severity of depressive symptom ranged from 0 to 27, in which each item can be score from 0 (not at all) to 3 (nearly every day). 0 indicates no depression and 27 indicates severe depression.
Change= (One week after the intervention score - Baseline score)
Measured: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of depressive symptoms assessed by The Patient Health Questionnaire (PHQ-9) at three months after the intervention.
A 9-item scale to measure the severity of depressive symptom ranged from 0 to 27, in which each item can be score from 0 (not at all) to 3 (nearly every day). 0 indicates no depression and 27 indicates severe depression.
Change= (Three months after the intervention score - Baseline score)
Measured: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in the score of anxiety assessed by Generalized Anxiety Disorder Scale (GAD-7) at one week after the intervention.
A brief self-report instrument to measure severity of anxiety with 7 items ranged from 0 to 21. 0 indicates no anxiety and 21 indicates severe anxiety.
Change= (One week after the intervention score - Baseline score)
Measured: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of anxiety assessed by Generalized Anxiety Disorder Scale (GAD-7) at three months after the intervention.
A brief self-report instrument to measure severity of anxiety with 7 items ranged from 0 to 21. 0 indicates no anxiety and 21 indicates severe anxiety.
Change= (Three months after the intervention score - Baseline score)
Measured: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in the score of psychological distress assessed by Impact of Events Scale -Revised version at one week after the intervention.
It has 22 items containing three domains: Intrusion, Avoidance, and Hyperarousal subscales using a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely) ranged from 0 to 88. 0 indicates low level of distress and 88 indicates severe distress.
Change= (One week after the intervention score - Baseline score)
Measured: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of psychological distress assessed by Impact of Events Scale -Revised version at three months after the intervention.
It has 22 items containing three domains: Intrusion, Avoidance, and Hyperarousal subscales using a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely) ranged from 0 to 88. 0 indicates low level of distress and 88 indicates severe distress.
Change= (Three months after the intervention score - Baseline score)
Measured: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in exercise capacity assessed by self-designed questions at one week after the intervention
Including the type of exercise (What kind of exercise do you usually do?); the intensity of exercise (What intensity of exercise do you usually do? Low/moderate/high?); frequency of exercise per week (How many times do you exercise on average a week?); and the duration of exercise each time (min) (How long will you take each exercise?) Change= (One week after the intervention score - Baseline score)
Measured: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in exercise capacity assessed by self-designed questions at three months after the intervention
Including the type of exercise (What kind of exercise do you usually do?); the intensity of exercise (What intensity of exercise do you usually do? Low/moderate/high?); frequency of exercise per week (How many times do you exercise on average a week?); and the duration of exercise each time (min) (How long will you take each exercise?) Change= (Three months after the intervention score - Baseline score)
Measured: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
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
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.
Change= (One week after the intervention score - Baseline score)
Measured: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
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.
Change= (Three months after the intervention score - Baseline score)
Measured: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in the score of acceptance assessed by Acceptance and Action Cancer Questionnaire at one week after the intervention
18-item questionnaire to measure experiential avoidance, in which participants response the possibility that they accept or avoid repulsive thoughts and feelings to each item using a 7-point Likert scale (1 = never true to 7 = always true) ranged from 18 to 126. The higher the overall score, the greater level of experiential avoidance or low level of acceptance. 18 indicates low level of acceptance and 90 indicates the high level of acceptance.
Change= (One week after the intervention score - Baseline score)
Measured: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of acceptance assessed by Acceptance and Action Cancer Questionnaire at three months after the intervention
18-item questionnaire to measure experiential avoidance, in which participants response the possibility that they accept or avoid repulsive thoughts and feelings to each item using a 7-point Likert scale (1 = never true to 7 = always true) ranged from 18 to 126. The higher the overall score, the greater level of experiential avoidance or low level of acceptance. 18 indicates low level of acceptance and 90 indicates the high level of acceptance.
Change= (Three months after the intervention score - Baseline score)
Measured: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in the score of cognitive fusion assessed by Cognitive Fusion Questionnaire at one week after the intervention
An instrument to measure cognitive fusion, one of the components in the model of psychopathology of ACT. It has 9 items scored by 7-point Liker scale (1 = never true to 7 = always true) ranged from 9 to 63. 9 indicates low level of cognitive fusion and 63 indicates the high level of cognitive fusion.
Change= (One week after the intervention score - Baseline score)
Measured: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of cognitive fusion assessed by Cognitive Fusion Questionnaire at three months after the intervention
An instrument to measure cognitive fusion, one of the components in the model of psychopathology of ACT. It has 9 items scored by 7-point Liker scale (1 = never true to 7 = always true) ranged from 9 to 63. 9 indicates low level of cognitive fusion and 63 indicates the high level of cognitive fusion.
Change= (Three months after the intervention score - Baseline score)
Measured: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Jul 2021
- Primary completion7 Jan 2022
- Study completion7 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiyuan LI, Chinese University of Hong Kong
- Investigators
- Huiyuan LI, Principal investigator, Chinese University of Hong KongCho Lee Wong, PhD, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869267
- Sponsor's protocol ID
- CREC Ref. No. 2020.581
- Acronym
- ACT
- Status last verified
- Oct 2022
- First submitted
- 27 Apr 2021
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04869267
- Acronym / sponsor ID
- ACT / CREC Ref. No. 2020.581
- Conditions
- Lung Cancer, Advanced Cancer
- Keywords
- lung cancer, palliative care, Acceptance and Commitment Therapy, fatigue, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 3 May 2021 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACT group | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT)Participants in the intervention group will receive ACT intervention, consisting of four individual sessions (First session by face to face, the last three sessions by Wechat) of 60-90 min each (once/week), in addition to usual care. |
| Usual care group | Other | Other: Usual careParticipants randomized to the control group will receive usual care, including treatments and daily care during admission, medication instructions, diet and exercise advice, retest recommendations when discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18 or over;
- diagnosed with stage III or stage IV lung cancer by pathological section or cytology;
- experienced unexplained fatigue syndrome: the score of 3 or more on the Fatigue Symptom Inventory (FSI); and
- able to provide informed consent and effectively collect data.
Key exclusion criteria (3 listed)
- diagnosed with cognitive dysfunction or other mental illnesses that may interfere with their completion of treatment;
- 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
- who are receiving or have just completed other lung cancer-related intervention programs within the last six months
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 |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)Session 1: This session aims to let the participants get familiar with the interventionist. The interventionist will tell them the purpose of the program and basic rules. And the interventionist will promise their privacy protection. Session 2: This session includes how to separate thoughts/feelings/sensations related to diagnose with advanced lung cancer and experience of fatigue with facts and see these feelings in an objective way with observing self. Session 3: This session mainly aims to help participants understand the importance of values, differentiate values from goals and clarify their personal values. Session 4: This session aims at helping patients practice to engaging in committed action based on chosen values, motivated to change behavior in consistency with life direction and health goal. | Behavioural | ACT group |
| Usual careThe usual care mainly includes treatments and daily care during admission, medication instructions, diet and exercise advice, retest recommendations when discharge | Other | Usual care group |
Primary outcome
Change from baseline in the score of fatigue interference assessed by The Fatigue Symptom Inventory at one week after the intervention
Time frame: Baseline (T0) and post-intervention (T1, one week after the 4-week 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. Change= (One week after the intervention score - Baseline score)
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
Time frame: Baseline (T0) and three months follow-up (T2, three months after the 4-week 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. Change= (Three months after the intervention score - Baseline score)
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
Time frame: Baseline (T0) and post-intervention (T1, one week after the 4-week 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)
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
Time frame: Baseline (T0) and three months follow-up (T2, three months after the 4-week 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= (Three months after the intervention score - Baseline score)
16 secondary outcomes
Change from baseline in the score of cancer related fatigue assessed by The Multidimensional Fatigue Inventory at one week after the intervention
Time frame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of cancer related fatigue assessed by The Multidimensional Fatigue Inventory at three months after the intervention
Time frame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in the score of depressive symptoms assessed by The Patient Health Questionnaire (PHQ-9) at one week after the intervention.
Time frame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of depressive symptoms assessed by The Patient Health Questionnaire (PHQ-9) at three months after the intervention.
Time frame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in the score of anxiety assessed by Generalized Anxiety Disorder Scale (GAD-7) at one week after the intervention.
Time frame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of anxiety assessed by Generalized Anxiety Disorder Scale (GAD-7) at three months after the intervention.
Time frame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in the score of psychological distress assessed by Impact of Events Scale -Revised version at one week after the intervention.
Time frame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of psychological distress assessed by Impact of Events Scale -Revised version at three months after the intervention.
Time frame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in exercise capacity assessed by self-designed questions at one week after the intervention
Time frame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in exercise capacity assessed by self-designed questions at three months after the intervention
Time frame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
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
Time frame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
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
Time frame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in the score of acceptance assessed by Acceptance and Action Cancer Questionnaire at one week after the intervention
Time frame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of acceptance assessed by Acceptance and Action Cancer Questionnaire at three months after the intervention
Time frame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Change from baseline in the score of cognitive fusion assessed by Cognitive Fusion Questionnaire at one week after the intervention
Time frame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)
Change from baseline in the score of cognitive fusion assessed by Cognitive Fusion Questionnaire at three months after the intervention
Time frame: Baseline (T0) and three months follow-up (T2, three months after the 4-week intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Huiyuan LI principal investigator
Chinese University of Hong Kong
Cho Lee Wong, PhD study director
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) in people with Lung Cancer and Advanced Cancer, run by Chinese University of Hong Kong at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 4 Oct 2022. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the score of fatigue interference assessed by The Fatigue Symptom Inventory at one week after the intervention (time frame: Baseline (T0) and post-intervention (T1, one week after the 4-week intervention)). The study lists 4 primary outcomes in all. 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 4 Oct 2022.