Acceptance and Commitment Therapy in Patients With Advanced Lung Cancer (ACT)

The Chinese University of Hong Kong

Status: Completed

Conditions: Advanced Cancer; Lung Cancer

Treatments: Behavioral: Acceptance and Commitment Therapy (ACT); Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04869267

CREC Ref. No. 2020.581

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

ACT group

Experimental group

Description:

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.

Treatment:

Behavioral: Acceptance and Commitment Therapy (ACT)

Usual care group

Other group

Description:

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.

Treatment:

Other: Usual care