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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

NCT05885984•Chinese University of Hong Kong

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

Xiangya Hospital Central South University

Changsha, Hunan, China

Key Dates

Start Date

July 1, 2023

Primary Completion Date

November 1, 2023

Completion Date

January 1, 2024

Last Updated

June 2, 2023

Enrollment

ESTIMATED participants

Conditions

Lung CancerAdvanced CancerCaregiver Burden

Interventions

Acceptance and Commitment Therapy (ACT) plus health education

BEHAVIORAL

Health education

OTHER

Contacts

Huiyuan LI, PhD

CONTACT

52665977 huiyuanli@cuhk.edu.hk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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