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

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

NCT ID: NCT05885984

Condition: Lung Cancer
Advanced Cancer
Caregiver Burden

Conditions: Official terms:
Lung Neoplasms
Fatigue
Caregiver Burden

Conditions: Keywords:
lung cancer
palliative care
Acceptance and Commitment Therapy
cancer-related fatigue
caregiver burden

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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 in addition to health education. Participants in Group B receive health education.

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Masking description: The outcomes assessor who is independent of the research will be trained before formally conducting data collecting.

Intervention:

Intervention type: Behavioral
Intervention name: Acceptance and Commitment Therapy (ACT) plus health education
Description: 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.
Arm group label: ACT group

Intervention type: Other
Intervention name: Health education
Description: 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.
Arm group label: Health eduction control group

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.

Criteria for 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. 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Xiangya Hospital Central South University

Address:
City: Changsha
Country: China

Contact:
Last name: Nina WANG, Master

Phone: +86 13974897928
Email: w.nn@qq.com

Start date: July 2023

Completion date: January 2024

Lead sponsor:
Agency: Chinese University of Hong Kong
Agency class: Other

Collaborator:
Agency: Association for contextual behavioral science
Agency class: Other

Source: Chinese University of Hong Kong

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05885984