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

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Advanced Cancer; Caregiver Burden; Lung Cancer

Treatments: Behavioral: Acceptance and Commitment Therapy (ACT) plus health education; Other: Health education

Study type: Interventional

Funder types: Other

Identifiers

NCT05885984

CREC Ref. No. 2023.030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated 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. 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

ACT group

Experimental group

Description:

Participants in the intervention group will receive ACT intervention, consisting of six online sessions via video conferencing platform (The first two sessions for patient only, the third and fourth sessions for caregiver only, and the last two sessions for patient-caregiver dyads) of 60-90 min each (once/week), in addition to health education.

Treatment:

Behavioral: Acceptance and Commitment Therapy (ACT) plus health education

Health eduction control group

Other group

Description:

Participants randomised to the health education control group will receive six weekly health education by a video-conferencing platform. The topics mainly include treatments and daily care during admission, medication instructions and side effects, diet and exercise advice, and retest recommendations when discharged.

Treatment:

Other: Health education