Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-29 @ 12:08 AM
Study NCT ID:
NCT04869267
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2021-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptance and Commitment Therapy in Patients With Advanced Lung Cancer
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
Effectiveness of Acceptance and Commitment Therapy on Fatigue Interference and Health-related Quality of Life Among Patients With Advanced Lung Cancer: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACT
Brief Summary:
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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: