NCT05885984

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

Effects of Acceptance and Commitment Therapy on Fatigue Interference in Patients With Advanced Lung Cancer and Caregiver Burden: A Pilot Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Advanced Cancer
• Caregiver Burden

Interventions

Type	Name	Description
BEHAVIORAL	Acceptance and Commitment Therapy (ACT) plus health education	Session 1: Reviewing experiences on struggles with CRF, realising consequence of controlling, introducing acceptance as an alternative, adopting virtual mindfulness. Education (patient): epidemiologic features of advanced lung cancer. Session 2: Separate thoughts/feelings related to CRF. Education (patient): treatments and symptoms of advanced lung cancer. Session 3: Reviewing caregiver's experiences of struggling with caregiving burden,introducing acceptance as an alternative. Education (caregiver): epidemiologic features of advanced lung cancer. Session 4: Separate caregivers' thoughts/feelings related to caregiving burden. Education (caregiver): treatments and symptoms of advanced lung cancer. Session 5:Understand the importance of values and clarifying personal values for dyads. Education (dyads): eating suggestions. Session 6: Emphasise ongoing value-based goals and commitment to actions for a meaningful cancer life for dyads. Education (dyads): exercising suggestions.
OTHER	Health education	Session 1: health education on the epidemiologic features of advanced lung cancer will be taught to patients. Session 2: health education on treatments and related symptoms of advanced lung cancer will be taught to patients. Session 3: health education on the epidemiologic features of advanced lung cancer will be taught to caregivers. Session 4: health education on treatments and related symptoms of advanced lung cancer will be taught to caregivers. Session 5: health education on eating suggestions for advanced lung cancer patients and caregivers will be taught. Session 6: health education on exercising suggestions for advanced lung cancer patients and caregivers will be taught.

Timeline

• Start date: 2023-07-01
• Primary completion: 2023-11-01
• Completion: 2024-01-01
• First posted: 2023-06-02
• Last updated: 2023-06-02

Locations

1 site across 1 country: China